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DIAGNOSTICS & IMAGING WEEKT HE W EEKLY D IAGNOSTICS T ECHNOLOGY N EWSPAPERTHURSDAY, MARCH 2, 2006 VOL. 9, NO. 9 PAGE 1 OF 13Mayo says cardiac test couldassess moderate-risk adultsBy KAREN YOUNGDiagnostics & Imaging Week Staff WriterA research team at the Mayo Clinic (Rochester, Minnesota)used a non-invasive tool, called an arterial tonometer,to discover an association between stiffness in arteries andthe presence and amount of coronary artery calcium, whichthe clinic said could lead to the accurate assessment of heartdisease risk in adults with no symptoms.Iftikhar Kullo, MD, of the Mayo Clinic and lead author ofthe study, told Diagnostics & Imaging Week that the test isfor people determined to be at intermediate risk based onrisk factors outlined by the guidelines published by theNational Cholesterol Education Project and assessed ascore based on the Framingham Risk Score.“About 40% of the American public is considered to beat moderate risk for heart disease,” said Kullo in a preparedstatement. “Nearly half the heart attacks come without3rd of 3 partsPoint-of-care testing seen asgrowing Asian market sectorBy MICHAEL SIMONSEN, PhDDiagnostics & Imaging Week Contributing WriterSINGAPORE – Sophisticated point-of-care tests arebecoming important factors in the Asian in vitro diagnosticsmarket, as discussed at the inaugural Diagnostics Asia2006 conference, organized by IBC Asia Pte Ltd. (Singapore)and held here in mid-January.William Cao of NeuPro Technology Co. Ltd. (Taipei,Taiwan) described a new POC test system based on thecompany’s NeuChip sensor, a low-cost biosensor that isbeing developed for time-critical diagnostic testing applicationssuch as cardiac testing, rapid pathogen identification,and food toxicology. The sensor is fabricated usingscreen-printed electrode technology, and features electrochemicaltechniques using enzyme labels to achieve highsensitivity and low cost.See Mayo, Page 8 See Asia, Page 9Study: Angiography may notID cardiac disease in womenBy KAREN YOUNGDiagnostics & Imaging Week Staff WriterAngiography for female patients who have presentedwith symptoms of cardiac distress appear to be not effectivein determining the possible extent of coronary arterydisease that may actually exist, according to new research.Therefore, new ways of diagnosing women need to bedeveloped or perfected, according to a series of studiesresulting from the Women’s Ischemia Syndrome Evaluation(WISE) study sponsored by the National Heart, Lung andBlood Institute (Bethesda, Maryland).The series was published in a supplement to the Feb. 7issue of the Journal of the American College of Cardiology.“[Researchers] conclude that about one-half of thewomen referred to a cardiology practice for suspectedischemia do not have obstructive coronary disease, yettheir prognosis is not benign in terms of future events andpersistent symptoms,” according to the introduction to theInternational reportPublic-private fund createdfor early investing in FranceA Diagnostics & Imaging Week Staff ReportInserm-Transfert, the venture capital subsidiary ofFrance’s National Institute for Health and <strong>Medical</strong> Research(Inserm) has teamed up with three other funds tocreate a new venture capital firm to provide seed capitaland proof-of-concept financing to biotechnology firms.Known as the Inserm-Transfert Initiative, the fund hasbeen established with a capital of EUR 4.2 million ($5 million)for an initial period of 10 years, which could be extendedfor two further periods of two years.Inserm-Transfert’s associates are Sofinnova Partners,CDC Enterprises and Ventech, all of Paris, each with a 25%interest in the new fund. Inserm-Tansfert Initiative expectsto announce its first investments in the near future.Its investment director, Jean-Pierre Loza, said thatmany would-be entrepreneurs have trouble finding preseedand seed capital, and that Inserm-Transfert had “chosento provide early stage support to innovative projects in series.See International, Page 11See Angiography, Page 10<strong>INSIDE</strong>:SARBANES-OXLEY CHANGES ARE PROPOSED BY SEC COMMITTEE................2ISRAELI FIRMS PUSH FOR NON-INVASIVE BLOOD GLUCOSE MONITORING .......3To subscribe, please call DIAGNOSTICS &IMAGING WEEK Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited.


THURSDAY, MARCH 2, 2006 DIAGNOSTICS &IMAGING WEEK PAGE 2 OF 13Sarbanes-Oxley changes areproposed by SEC committeeBy AARON LORENZODiagnostics & Imaging Week Washington WriterWASHINGTON – Smaller life sciences companies sooncould see some relief from one of the Sarbanes-Oxley Act’smore burdensome regulations, if the SEC adopts recommendationsput forth by an advisory committee last week.Importantly for the industry, the SEC’s 21-memberAdvisory Committee on Smaller Public Companies has proposedchanges to Section 404 of the corporate governancelaw, which has been criticized for its sweeping approach.The <strong>Medical</strong> <strong>Device</strong> Manufacturers Association(MDMA; Washington), which counts among its membersmostly smaller device firms and has been active in pushingfor reforms because of its charge that Sarbanes-Oxley waswritten without forethought to such companies, is largelybehind the recommendations.Mark Leahey, the association’s executive director, toldDiagnostics & Imaging Week that the proposals are “a stepin the right direction.” He added that the intent underlyingSarbanes-Oxley “is pure,” but stressed that the resultingunintended consequences have placed “extremely burdensomehurdles and costs associated with them” on smallercompanies, funds that instead would go toward researchand development.Therefore, he said it was critical that the committeerecognized that the law’s one-size-fits-all approach is notthe solution to better corporate governance. Section 404reform is atop the committee’s list of the draft report recommendations.Notable are definitions of smaller public companies,which if adopted would encompass 80% of all U.S. publiccompanies, though reforms would impact only a few ofthem. Specifically, the committee proposed that micro-capcompanies have common stock (or equivalent) equal to thelowest 1% of total U.S. equity market capitalization (cur-rently about $128 million), and small-cap companiesinclude those with common stock (or equivalent) thattotals the next lowest 5%. Therefore, smaller public companies– micro-cap and small-cap – would comprise the lowest6% of U.S. market cap.Certain smaller public companies would benefit fromthe committee’s recommendations for reforming Section404 of Sarbanes-Oxley, viewed by many as its most onerousaspect. Section 404 calls for upper management to attest tofinancial statements and employ external auditors.The management attestation provision is essentiallyrepetitive, as Section 302 of Sarbanes-Oxley alreadyrequires the filing of financial reports, and the externalaudit provision has proven overly costly to companies withlittle to no revenue.The committee’s endorsements include an outrightexemption to Section 404’s requirements to micro-capcompanies with less than $125 million in annual revenueand small-cap companies with less than $10 million inannual revenue, provided that their corporate governancecontrols include adherence to additional standards underearlier laws. The committee further suggested that smallcapcompanies be exempt from external auditor involvementin the Section 404 process if their annual revenueranges between $10 million and $250 million, subject tocompliance with the same aforementioned corporate governancestandards. An additional category would excusecompanies with revenues of less than $10 million but witha market cap up to $787 million.The SEC commissioned the advisory committee morethan a year ago to consider Sarbanes-Oxley reforms. Acommittee meeting scheduled for this week will include avote on this draft, followed by a 30-day public commentperiod. Leahey said MDMA would use that period to submitfurther thoughts on Sarbanes-Oxley reform. A final reportto the SEC is due by April 30.MDMA’s efforts are borne in part through a coalitionformed by the Biotechnology Industry OrganizationSee Sarbanes-Oxley, Page 7DIAGNOSTICS &IMAGING WEEK is published weekly by Thomson BioWorld ® , 3525 PiedmontRoad, Building Six, Suite 400, Atlanta, GA 30305. Opinions expressed are not necessarilythose of this publication. Mention of products or services does not constitute endorsement.DIAGNOSTICS &IMAGING WEEK is a trademark of Thomson BioWorld ® , a Thomson HealthcareCompany. Copyright © 2006 Thomson BioWorld ® . All Rights Reserved. No part of this publicationmay be reproduced without the written consent of Thomson BioWorld ®ATLANTA NEWSROOM: Executive Editor: Jim Stommen. Managing Editor: Don Long.Associate Managing Editor: Holland Johnson. Staff Writer: Karen Young.Production Editor: Kim Urquhart.BUSINESS OFFICE: Vice President/Group Publisher: Donald R. Johnston.Marketing Manager: Chris Walker.Account Representative: Steve Roberts.REPRINTS:For photocopy rights or reprints, please call Stephen Vanceat (404) 262-5511 or e-mail him at stephen.vance@thomson.com.SUBSCRIBER INFORMATIONPlease call (800) 688-2421 to subscribeor if you have fax transmissionproblems. Outside U.S. and Canada,call (404) 262-5476. Our customerservice hours are 8:30 a.m. to 6:00p.m. EST.EDITORIALDon Long, (404) 262-5539Fax: (404) 814-0759VP/GROUP PUBLISHERDonald R. Johnston, (404) 262-5439INTERNETwww.ahcpub.comTo subscribe, please call DIAGNOSTICS &IMAGING WEEK Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited.


THURSDAY, MARCH 2, 2006 DIAGNOSTICS &IMAGING WEEK PAGE 3 OF 13Report from IsraelRace still on for non-invasiveblood glucose monitoringBy RAE FISHMANDiagnostics & Imaging Week Contributing WriterZICHRON YAAKOV, Israel – A feverish race continues fora stand-alone, non-invasive monitoring device that doesnot need to be used along with conventional blood glucosemonitoring of blood samples, and three Israel companiesare among the participants.Start-up OrSense (Nes Ziona, Israel) just completed a$6 million private financing for its non-invasive electroopticaltechnology that provides spot or continuous monitoringof blood constituents such as glucose, hemoglobin(Hb), hematocrit (Hct) and oximetry (SpO 2 ), using the fingeras a testing site.Israel Healthcare Ventures (IHCV; Tel Aviv, Israel) ledthe in-vestment, along with STAR Ventures and Lewis TrustGroup and others.OrSense Chairman Shimon Eckhouse is enthusiastic.Eckhouse, who recently was voted Ernst & Young’s entrepreneurof the year for Israel in life sciences, said, “Webelieve that this additional investment will help us establishOrSense as the world leader in non-invasive glucosemonitoring, able to eliminate multiple needlepricks tomonitor blood sugar levels throughout the day. This is asignificant improvement in the quality of life for peoplewith diabetes, a trend we see extending into the future.”So far OrSense is on track to become another Eckhouseblockbuster. Even if it does not take all, there is plenty ofspace to maneuver in this $8 billion monitoring market.The company’s intellectual property portfolio consistsof 18 granted patents, with another 25 in process. OrSenseproducts are based on its occlusion spectroscopy technology.Other of its products focus on non-invasive monitoringof other critical blood parameters, such as hemoglobin.Carlo Salvi, a director at Teva PharmaceuticalIndustries (Petach Tikva, Israel), has been named to theOrSense board. He said, “The prospect of working withOrSense as a director and an advisor is exciting. I have alsodecided to increase my investment in the companythrough IHCV, because I believe that their unique non-invasivemonitoring systems address major unmet medicalneeds and represent a potential for rapid market acceptanceand profitability.OrSense is running in this race of tell-but-don’t-touchblood sugar monitors with two other Israeli-born endeavors.Glucon (Boulder, Colorado), developing a continuous,non-invasive, glucose monitoring technology for home andclinical use, was founded in 2000 by two Israelis, companypresident Ron Nagar and vice president for R&D, BennyPesach. Glucon has R&D offices in Petach Tikva, Israel.The company’s technology uses photoacoustics toread glucose levels directly from a blood vessel. Gluconwas granted a patent and its flagship product, the GlucoseMonitoring Watch, a digital watch/meter that constantlychecks the glucose level in the bloodstream, is currently inclinical trials.Called Aprise, it will display a continuous reading ofthe patient’s real-time blood glucose level, enabling thepatient to take the necessary measures to remain withinglucose-safe limits. Ultrasound imaging is employed toidentify a blood vessel and optical spectroscopy is used toquantify the glucose concentration within the blood vessel.Pesach said the company has demonstrated excellentprospective clinical results. These include the most recentstudy of 23 subjects, 309 capillary blood tests yielding precise(20mg/dL) and accurate results.The start-up raised $14.8 million financing in round C.NetRegulus, an established provider of enterprise compliancesoftware for regulated industries, said that Gluconhas selected the new NetRegulus NetRM Software as aService (SaaS) Study solution to manage the next phase ofits aggressive clinical trial schedule.“NetRegulus’ experience and significant knowledge ofregulated life sciences was a key factor in our decision process.The NetRegulus SaaS solution promises to helpreduce time to market while simultaneously improving theability to successfully manage critical data in preparationfor successful FDA submissions,” said Glucon CEO DanGoldberger.Another group of Israeli entrepreneurs saw the marketpotential and founded Integrity Applications in September2001. Its non-invasive device for measuring bloodglucose levels, GlucoTrack, has a triple cross-checkingdevice for measuring blood glucose levels.Integrity Applications co-founder, CEO Avner Gal, saidthe three separate measuring technologies are neededbecause “the human body is a complex target, as well asone that demands extreme accuracy.” The technology forseparate cross-checking and the processing algorithm thatsupports them has a U.S. patent for the combination of thethree technologies.Gal said that more than 10 companies worldwide aretrying to develop a viable solution. “We have a final modelwith 100 units ready for clinical trials,” he said, developed ata cost of under $2 million invested from private investors.Integrity Applications is holding another financinground of $1.5 million, “which ought to be our last roundbefore we go to market,” he said. “We prefer strategicinvestors with strategic capabilities.”Israeli firm in telemedicine effortVisonic (Tel Aviv), a maker of electronic security systemsand home management systems, reported strengtheningits position in home healthcare by entering theSee Israel, Page 7To subscribe, please call DIAGNOSTICS &IMAGING WEEK Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . 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THURSDAY, MARCH 2, 2006 DIAGNOSTICS &IMAGING WEEK PAGE 4 OF 13Financings roundupIntermagnetics General filesshelf registration with SECA Diagnostics & Imaging Week Staff ReportIntermagnetics General (Latham, New York) reportedfiling a shelf registration with the Securities andExchange Commission (SEC) enabling it to offer preferredstock, common stock, senior and subordinated debt andwarrants, as well as units and purchase contracts that mayinclude one or more of those securities. It did not specifythe number of shares or proposed pricing.“It is both timely and appropriate to add a shelf registrationstatement to our portfolio of tools to pursue ourstrategic objectives,” said Glenn Epstein, CEO and chairman.“While we have no imminent needs or present plansto issue securities, we are positioning ourselves to beincreasingly nimble and flexible . . .”Intermagnetics offers products in the MRI market, pluswhat it terms “expanding businesses within medicaldevices that encompass in vivo diagnostic imaging . . . andin vivo patient care.” The company also participates insuperconducting applications for energy technology.Medwave (Danvers, Massachusetts) said it has closedon more than $4.43 million of additional capital to help furtherfund its growth and “aggressive market entry” with thePrimo system, Legato OEM Developer’s Kit and other newproducts expected to be released during 2006.The terms of the financing included the sale of morethan 1.6 million shares of common stock at a price of $2.74per share with additional investment rights (warrants) forup to 404,403 shares of common stock at an exercise priceof $3.29 per share.The additional warrants are exercisable only after sixmonths from the closing date and have a five-year life.Canaccord Adams Inc. was placement agent.The financing was led by H&Q Healthcare Investorsand H&Q Life Sciences Investors (San Francisco). Additionalinvestors included Heartland Advisors (Milwaukee), NiteCapital (Chicago), Paragon Capital (New York) and certainother smaller investors.Medwave develops sensor-based non-invasive bloodpressure solutions.In other financing news:• Cepheid (Sunnyvale, California), said it has filed apreliminary prospectus supplement with the Securities andExchange Commission relating to an underwritten publicoffering of 10 million primary shares of common stock plusan option to purchase up to an additional 1.5 million sharesto cover any over-allotments.The book-running manager of the proposed offering isUBS Investment Bank, and co-managers are William Blair &Co. and Robert W. Baird & Co.Cepheid is a molecular diagnostics company thatdevelops integrated systems for genetic analysis in theclinical, industrial and biothreat markets. The company’ssystems are designed to enable rapid, sophisticatedgenetic testing for organisms and genetic-based diseasesby automating otherwise complex manual laboratory procedures.• HealthSouth (Birmingham, Alabama) said it plans toissue up to $300 million of convertible perpetual preferredstock through an offering to qualified institutional buyersvia a private placement exemption under the Securities Actof 1933.This new offering follows on the heels of the company’sproposed $445 million class- action settlement forfederal securities and fraud claims.This preferred stock will be convertible intoHealthSouth common stock.The company said that the purpose of the preferredstock issuance is to reduce HealthSouth’s outstandingindebtedness.If the company successfully completes its previouslydisclosed recapitalization transactions, the amount ofsenior unsecured interim term loans the company will bepermitted to borrow in connection with the recapitalizationtransactions will be reduced by the amount of grossproceeds that HealthSouth receives from the preferredstock issuance.If the recapitalization transactions are not completed,the company will use the net proceeds that it receives fromthe preferred stock issuance to repay a portion of its outstandingsenior unsecured indebtedness.HealthSouth is one of the nation’s largest providers ofoutpatient surgery, diagnostic imaging and rehabilitativehealthcare services, operating facilities nationwide.• Imagin Molecular (Oakbrook, Illinois) reported thatthe company’s wholly owned subsidiary, Positron Acquisition,has reached an agreement with Positron (Houston)to convert a convertible promissory note into about70 million shares of Positron common stock.The transaction will be effective immediately upon ratificationof Positron’s increase of its authorized stock. Theshares will be restricted and at current prices have a valueof about $14 million.Imagin is dedicated to business opportunities in positronemission tomography manufacturing. ■Advances in Diagnostics & Imaging: Emerging Markets for the 21st CenturyThis new report features more than 300 pages of information to help you understand the diagnostics and imaging markets andseize opportunities in this fast-paced industry. Order today by calling 1-800-688-2421 or 1-404-262-5476.To subscribe, please call DIAGNOSTICS &IMAGING WEEK Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited.


THURSDAY, MARCH 2, 2006 DIAGNOSTICS &IMAGING WEEK PAGE 5 OF 13Court reportPatent dispute ending withInverness buy of ACON unitA Diagnostics & Imaging Week Staff ReportA nearly three-year-long patent dispute between twomedical diagnostics companies reached an unexpectedending recently with one company agreeing to buy theother’s rapid diagnostics business.Inverness <strong>Medical</strong> Innovations (Waltham, Massachusetts)has agreed to acquire the rapid diagnostics businessfrom ACON Laboratories (San Diego) for $175 million. Thedeal ends a patent infringement case brought by Invernessin 2004 over some of ACON’s core rapid test technology.ACON’s lateral-flow immunoassay business, which iswhat Inverness is acquiring, had 2005 revenue of $50 millionand operating income of $17 million. As part of the announcedsettlement, Inverness also will acquire ACON’s newly-constructedmanufacturing facility in Hangzhou, China.The acquisition is expected to close in the first or secondquarter, with the Hangzhou manufacturing facility tobe acquired through a separate closing expected to occurby the end of 2Q06.The aggregate purchase price for the acquired business,including the manufacturing facility, will be $175 million,subject to adjustment for working capital and netindebtedness with Inverness assuming, on a consolidatedbasis, up to $4 million in indebtedness related to theHangzhou facility.Inverness will pay ACON about $75 million at the closingof the acquisition and $20 million upon closing on theHangzhou facility. The remainder of the aggregate purchaseprice will be paid on completion of certain milestonesrelated to achievement of functional manufacturing targetsrelated to the products sold in each of the territories.The purchase price will be paid by issuing an aggregateof up to $50 million of Inverness common stock toACON, with the remainder being paid in cash.The deal involves ACON’s business in the U.S., Canada,Western Europe, Israel, Australia, Japan and New Zealand.The two companies said they also expect to enter into anagreement at the time of the closing under which Invernesswould agree to acquire ACON’s rapid diagnostic businessin the rest of the world in about three years, subject to satisfactionof certain future financial performance and operationalconditions.Inverness CEO Ron Zwanziger said that by acquiring themajority of the rapid diagnostic test business of ACON, “whohas proven to be an efficient manufacturer of both consumerand professional diagnostic products, we are adding significantrevenues at attractive margins as well as manufacturingcapabilities that will benefit us companywide.”Zwanziger said, “We are pleased to fully settle our infringementclaims against ACON,” adding that the strengthof the company’s patents “will be validated in several keyjurisdictions through the issuance of permanent injunctions,including findings of infringement.”He said that in order to leverage the ACON business’s“unique and successful operating philosophy,” Invernessintends to continue that business as a stand-alone salesunit operating through its existing distribution channels.David Doyle, a partner in the New York law firm ofMorrison & Foerster, which represented ACON in the underlyingpatent litigation, said, “This is a tremendous outcomefor both companies, one that we have been hoping for eversince the patent litigation commenced several years ago.We are pleased that the company has forged a partnershipwith Inverness to advance its innovative diagnostic capabilitiesinternationally.”In other legalities:• The U.S. District Court in Denver has dismissed alongstanding patent infringement lawsuit filed by Medtronic(Minneapolis) against BrainLAB (Westchester, Illinois).The suit originally was filed in 1998.The court ruled that, as a matter of law, BrainLAB’s imageguidedsurgery/radiotherapy products do not in-fringe anyof the patents involved in the suit, determining that the evidencedoes not support a finding of infringement.In September, a Denver jury had reached a verdict findingthat BrainLAB infringed four patents held or licensed byMedtronic, and determined that a reasonable royalty onBrainLAB product sales in the U.S. amounted to $51 million.The court’s ruling set aside that jury verdict and precludesthe injunction Medtronic had been seeking.“We are pleased to see that the court has confirmed theuniqueness of our image-guided technology and that ourtechnology does not infringe Medtronic’s patents,” said StefanVilsmeier, BrainLAB founder and CEO. “We look forward tocontinued success in our surgical navigation business and tosupplying our partners with our advanced technology.”• The Birmingham News last week reported that a federaljudge has denied the latest attempt by RichardScrushy, former CEO of HealthSouth (Birmingham, Alabama)to have the Securities and Exchange Commission(SEC) lawsuit against him dismissed, paving the way for atrial in 2007.It reported that in a one-page order, without elaboration,U.S. District Court Judge Inge Johnson denied Scrushy’smotion for dismissal and said that the SEC lawsuit canproceed – almost three years after its filing. The chargesinclude two counts of fraud and four counts of fraudrelatedclaims.The SEC is attempting to recover hundreds of millionsof dollars it describes as ill-gotten gains as the result of theaccounting fraud at HealthSouth while Scrushy headed therehabilitation chain.Johnson previously set a schedule for depositions andexpert witness preparation to last through this year, with atrial slated to begin April 2, 2007.See Court, Page 6To subscribe, please call DIAGNOSTICS &IMAGING WEEK Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited.


THURSDAY, MARCH 2, 2006 DIAGNOSTICS &IMAGING WEEK PAGE 6 OF 13Deals roundupSchering in radiopharma sale;Legacy assets to CornerstoneA Diagnostics & Imaging Week Staff ReportSchering (Berlin) reported that its French subsidiary,Schering SAS, would transfer the radiopharmaceuticalbusiness of CIS bio international to a consortium formedby the Belgian companies Ion Beam Applications and theInstitut National des Radioelements. An agreement wassigned by the parties on last week.As part of the transaction, the consortium acquiresSchering’s current radiopharmaceutical business, whileSchering will continue to focus on the diagnostic fields ofMRI, computed tomography, and optical as well as molecularimaging.Closing of the transaction is expected in the first halfof 2006.About 750 employees in different countries will continueemployment under the ownership of the consortium.This divestment is part of Schering’s FOCUS initiativeand will contribute to further improve the company’s profitability,it said.The transaction will have a negative one-time effect ofabout EUR 50 million on Schering’s operating profit for fiscal2006.“We are highly committed to drive innovation in thefield of diagnostic imaging,” said Karin Dorrepaal, memberof the executive board of Schering responsible for itsDiagnostic Imaging business. “We realign our strategy inthe area of diagnostic imaging to focus on innovativegrowth opportunities and to increase our operating performancein this area at the same time.”MedMira (Halifax, Nova Scotia), a developer of rapiddiagnostic solutions, has closed on its acquisition ofSensorChem International (Toronto), which initially wasannounced in mid-December.Stephen Sham, chairman and CEO, said, “Our new division,Maple BioSciences, will focus on the commercializationof the breakthrough technologies developed bySensorChem, bringing to market a new product line and furtherstrengthening MedMira’s suite of diagnostic products.”MedMira has acquired all of the outstanding commonshares of SensorChem and retired $1,374,129 in that company’sdebt and preferred share interests, for a total considerationof $2,063,729. MedMira has issued 2,948,184common shares at a price of 70 cents a share, including409,973 common shares to a director of MedMira.Under the terms of the acquisition agreement, certainshareholders have agreed to trading restrictions where2,373,042 of the shares issued cannot be traded for 180 daysfrom the date of closing and 470,000 shares will be restrictedfrom trading for up to three years from the date of closing.MedMira said it is the leading global manufacturer of invitro flow-through rapid diagnostic tests, providing resultsin just three minutes for the detection of antibodies inhuman serum, plasma or whole blood for diseases such asHIV and hepatitis C.In other deal-related news:• Siemens <strong>Medical</strong> Solutions (Malvern, Pennsylvania),with its subsidiary PETNET Pharmaceuticals (Knoxville,Tennessee), reported acquiring New England PET-NET Manufacturing & Distribution Center (Woburn,Massachusetts), enabling the provision of biomarkers forclinical and pre-clinical positron emission tomography(PET) imaging to the New England region through PETNET’sSafetyNet international network of more than 45 manufacturingand distribution centers.Siemens bills PETNET as the world’s leading producerof PET biomarkers, with the largest U.S. network ofcyclotron-equipped radiopharmacies. Molecular imagingbiomarkers – small tracers that monitor biological processes– enable identification of the biological mechanismsof disease to determine personalized therapies.“PETNET customers in the New England region will haveaccess to an array of programs to support and enable thecontinuous development of their skills, productivity andtechnology,” said Michael Reitermann, president, MolecularImaging Division, Siemens <strong>Medical</strong> Solutions.A unit of Siemens (Erlangen, Germany), Siemens<strong>Medical</strong> operates in more than 120 countries and reportedsales of EUR 7.6 billion in 2005• CytoCore (formerly Molecular Diagnostics; Chicago)said it has entered into an agreement to purchase a contractfrom a private individual giving the holder the right toreceive a 10% undiluted interest in Diamics, a privatelyheld company founded by Peter Gombrich, former CEO andchairman of Molecular Diagnostics. Diamics was foundedwhile Gombrich was working at Molecular Diagnostics.CytoCore is developing the InPath cancer-screeningsystem for use in a laboratory or at the point of care toassist in the early detection of cervical, endometrial andother cancers. ■CourtContinued from Page 5The SEC amended its lawsuit against Scrushy threetimes after the case was put on hold pending the outcomeof a criminal fraud trial against him. Scrushy was acquittedof all charges in that case last June.In the SEC lawsuit, Scrushy’s lawyers had argued theSEC failed to justify its charges with enough evidence thatwould cause a reasonable person to have a strong inferencethat the HealthSouth founder was involved in theaccounting fraud. That fraud produced a false inflation ofthe organizations revenues by about $2.6 billion over theperiod 1996 to 2002.HealthSouth is one of the nation’s largest providers ofoutpatient surgery, diagnostic imaging and rehabilitativehealthcare services, operating facilities nationwide. ■To subscribe, please call DIAGNOSTICS &IMAGING WEEK Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited.


THURSDAY, MARCH 2, 2006 DIAGNOSTICS &IMAGING WEEK PAGE 7 OF 13Agreements roundupGenetic Technologies formsalliance with MetaMorphixA Diagnostics & Imaging Week Staff ReportGenetic Technologies (GTG; Melbourne, Australia)reported forming an alliance with MetaMorphix (MMI;Beltsville, Maryland), a developer of new genetic markers.In 2004, MMI took a license to the GTG non-codingpatents, and since then the two companies have maintainedclose contact. GTG and MMI have both pursued thedevelopment of new technologies with applications inhuman health and diagnostics and also in animal geneticsand genomics.GTG and MMI recently identified several overlappinginterests and now will explore joint commercialization ofthese new opportunities, utilizing the combined power ofthe intellectual property held by each. The companies saidthey also would explore ways to optimize the geographicadvantage of GTG’s testing lab and MMI’s testing lab inDavis, California.BD Diagnostics (Baltimore), a segment of BD (Becton,Dickinson and Co.; Franklin Lakes, New Jersey) reported thesigning of a multi-year agreement with Quest Diagnostics(Lyndhurst, New Jersey) to supply instrumentation andreagents for testing and diagnosis of sexually transmitteddiseases (STD).This enterprise-wide adoption of the BD Viper Systemby Quest Diagnostics “takes full advantage of the BD ViperSystem’s robust industrial-class robotic design,” BD said.Pipetting, incubations, amplification and detection alloccur on the deck of the BD Viper System, with the majorityof labor delegated to the robot.The BD Viper System is designed to minimize technologisthands-on-time, enabling walkaway or “load and go”workflow. The new system is expected to help facilitaterapid turn-around of test results and provide more flexibilityin sample types for testing.In other agreements:• Acacia Research (Newport Beach, California) reportedthat its CombiMatrix (Mukilteo, Washington) grouphas established a Cooperative Research and DevelopmentAgreement (CRADA) with the U.S. Air Force ResearchLaboratory, Human Effectiveness Directorate, Biosciencesand Protection Division, Applied Biotechnology Branch(AFRL/HEPB).The CRADA will focus on “Development of a Biomonitor<strong>Device</strong> with Biomarker-based Microarrays.”AFRL/HEPB and CombiMatrix will develop a personalhealth monitoring system utilizing the company’s Custom-Array technology. The goal of the program is to develop aminiaturized device capable of analyzing multiple biomarkers(either DNA or protein) that would aid the Departmentof Defense in its mission to effectively monitor thehealth status of military service personnel before, during,and after deployment where untoward exposures mayimpact on their performance or health.• Laboratory Corporation of America Holdings(LabCorp; Burlington, North Carolina) reported that it hasentered into an exclusive license agreement with YaleUniversity (New Haven, Connecticut) to commercializethe university’s new blood testing technology for epithelialovarian cancer.Under the terms of the agreement, Yale will receivesigning, milestone and royalty fees. Additional terms werenot disclosed.The Yale technology is based on a collection of knownserum proteins associated with cancer biology. Each proteinmarker is analyzed using a routine ELISA assay, and astraightforward statistical analysis is then performed toscore the combined results. In published research, multiplestatistical analyses on preliminary sample sets for a populationof 206 women, including 24 patients with early stage(I/II) EOC and 76 with later stage (III/IV) EOC, showed veryfavorable sensitivity and specificity, as well as positive predictivevalue.Yale expects to conduct additional clinical studies onthe test technology prior to its commercial introduction byLabCorp. ■Sarbanes-OxleyContinued from Page 2(also Washington), to fight for reform on behalf of biotechnology,healthcare technology, high technology and venturecapital industries. The coalition, which includes theother Washington-based device industry trade association,the Advanced <strong>Medical</strong> Technology Association, representsmore than 5,300 companies from all 50 states andaround the world.Opposition to Sarbanes-Oxley reforms has come fromthe four major accounting firms in the U.S., which have saidthat Section 404 audit costs would come down after a year,as well as from some consumer groups. ■IsraelContinued from Page 3telemedicine sector through a partnership agreement withTMT Telemedicine Web <strong>Medical</strong> Center.The agreement signed with the controlling shareholdersof TMT establishes a partnership between Visonic andTMT, within the framework of a company called Visonic-TMT Telemedicine (Lyon, France).In exchange for an investment of EUR 711,366, Visonichas gained a 12.15% stake in the newly formed company.Visonic said the alliance will give it an enhanced marketingand sales platform with which to expand into thetelemedicine field, on the basis of TMT’s package of solutionsin the area of home healthcare and telemedicine. ■To subscribe, please call DIAGNOSTICS &IMAGING WEEK Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . 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THURSDAY, MARCH 2, 2006 DIAGNOSTICS &IMAGING WEEK PAGE 8 OF 13MayoContinued from Page 1warning, which means we need to do a better job of screeningpeople. This test has that potential.”The study was published in the current edition ofHypertension, a publication of the American Heart Association(Dallas).The test, which is called aortic pulse wave velocity(aPWV), measures how fast the pulse wave travels downthe aorta, or the major artery arising from the heart. Mayosaid it is a potential screening tool because it is quick, takingonly 10 to 15 minutes, painless and likely to be lessexpensive compared with other cardiac screening tests.For the test, the patient lies on a bed and a tonometeris placed on the skin over the carotid artery in the neck andthen the femoral artery, which is located in the upper thigh.The tonometer measures the pressure wave inside theartery, and the information is fed into a computer for calculationof aPWV.Kullo said a slower pulse means the artery is more elasticand healthier, while a faster wave means the artery isstiffer and less healthy.“If you have an electrocardiogram running [simultaneously]. . . then you can tell from when the heart pumpsblood [where] it is at a particular phase in the electrocardiogramwhen the actual pressure wave reaches a particularartery,” Kullo told D&IW.To get a measurement, one measures the onset of thetime of the blood in the heart to cycle to the waveform, hesaid.“So if you subtract that time delay, that’s the time portionof this equation, and then the distance is simply measuredby a measuring tape from the heart to the groin;[and] then we have time, we have distance, so we calculatethe velocity, and that’s the aortic pulse wave velocity,” Kullosaid.Researchers tested 401 patients, including 213 men and188 women, between the ages of 32 and 84 – none of whomhad a history of heart attack or stroke – for the researchconducted between 2002 and 2004. The median age was60. The study used a device called the SphygmoCor Systemby AtCor (West Ryde, Australia).The research found that study participants with stifferarteries had a greater amount of calcium in the coronaryarteries, an indicator of atherosclerosis.“Previous research showed an APWV predicts cardiovasculardisease in older adults, but the association ofaPWV and the amount of coronary artery calcium (CAC) inthe general population had been “unknown,” Kullo said.Kullo also said the association between artery stiffnessand CAC “strengthens the case for using aPWV as a screeningtool,” such as in adults with moderate risk, those with afamily history of heart disease, patients with high bloodpressure and those with kidney disease.In addition to publication, Kullo said Mayo hopes thathis particular non-invasive test will ultimately become partof a panel of non-invasive tests: the first test would be theaPWV; the second test would relate to endoluminal functionto ensure that the lining of the vessels is healthy; while thethird test would be designed to assess plaque in thecarotid arteries.“What we’re hoping is that we [can] try and evaluatethe function of the arteries in a comprehensive fashion,” hesaid, later adding, “Between these three tests, we can get agood idea of the health of the arterial system, so that’s howwe plan to use it.” ■Advances in Cardiovascular Technology Vol. 3:State of the Industry and Emerging MarketsAdvances in Cardiovascular Technology features more than 200 pages of information to help you understandthe primary markets in this keystone area of medical technology in order to seize the opportunities in this fastpacedindustry:• Overview of the sector — disease data and sector opportunities• New data for 2006 — company/market info; tables and charts• Major technology developments — a review of 15 sub-sectors ranges from drug-eluting stentsto artificial hearts to advances in tissue engineering for repair of the heart• Patent and regulatory data — legal perspectives and clinical trial• Dealmaking and financing — consolidations and major funding• Major firms — review of large players in cardiovascular technology• Emerging companies — highlighting new companies with potential breakthrough technologiesGo to <strong>Medical</strong><strong>Device</strong><strong>Daily</strong>.com to order!To subscribe, please call DIAGNOSTICS &IMAGING WEEK Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited.


THURSDAY, MARCH 2, 2006 DIAGNOSTICS &IMAGING WEEK PAGE 9 OF 13AsiaContinued from Page 1The test system consists of a test cartridge and areader that connects to a Personal Digital Assistant fordata storage and analysis. Total test turnaround time isless than three minutes for cardiac marker tests nowunder development. A rate-sensing method is used inthe analysis, minimizing background effects. Additionaltests for infectious disease are in the pipeline. Thecompany is interested in licensing the technology fordiagnostic applications, and is searching for strategicpartners.Another company focusing on point-of-care testing forinfectious agents, the Foundation for Innovative NewDiagnostics (FIND; Geneva, Switzerland), is developingnew POC tests for tuberculosis with funding from theWorld Health Organization (WHO; also Geneva). FIND isa non-profit company founded in 2003 and has beenfunded through a $30 million initial investment by WHO asa spin-off from that organization. FIND is focused on thepublic health sector, with a goal of helping to reducedeaths due to infectious disease, which accounts for 45% ofall deaths in Asia.As discussed at the conference by Giorgio Roscigno,CEO of FIND, the initial focus of development efforts is onTB and malaria diagnosis. Existing TB test methods have alow diagnostic yield, with only 19% of all incident TB casesdetected and reported as smear-positive in spite of the factthat over $1.2 billion is spent annually on TB diagnostictests, as shown in the accompanying table.Worldwide, 8.7 million new cases of TB occur annually,mostly in East Asia and Africa. One new test that isbeing developed by Proteome Sytems (North Ryde,Australia) is the DiagnostiQ antigen-based assay for usein developing countries. The test is designed to detect apanel of 62 proteins that are expressed in patients withTB infection. The target patient population for the test isthe 16 million patients worldwide who are co-infectedwith HIV and TB. The test uses sputum, blood or plasmasamples to detect active TB infections and has an analyticalsensitivity of 100 pg/mL. Diagnostic sensitivity,however, for detection of TB infection is only 70%, andefforts are under way to improve sensitivity prior tolaunching the test. Jenny Harry, PhD, of Proteome Systems,who discussed the new TB test at the conference,said a prototype test is to be available by December ofthis year.FIND also is also evaluating low-cost nucleic acidamplification technology for TB testing, and is working inpartnership with BD (Franklin Lakes, New Jersey) to introducerapid blood culture testing in Asia using the BD BBLMGIT system, which allows a reduction in turnaround timefrom 45 days to 14 days. Another TB test under evaluationby FIND uses phage technology combined with nucleic acidamplification for three- to four-day direct (non-culture)Current Global Direct Expenditureson Tuberculosis Diagnostic TestsTest TypeAnnual WorldwideExpendituresMicroscopy $324,906,257Culture $376,258,898*X-ray $509,406,090Mantoux (skin testing) $580,955,889Nucleic acid testing $35,119,542*Total>$1.2 billion*Manufacturers' cost applied. Reimbursement cost may be higher.Source: Roscigno, G., Foundation for Innovative NewDiagnostics, presented at Diagnostics Asia 2006detection of TB in sputum.FIND also is targeting development of improved diagnostictests for malaria, a disease affecting 40% of theglobal population with a prevalence of 300 million cases,mostly in Africa, Southeast Asia and India, and the northerncountries in South America. Although microscopy is thestandard method used in malaria diagnosis, it is highlyuser-dependent and requires skilled personnel in order toobtain reliable results. There is an increased demand foraccurate remote diagnostic malaria tests that can be usedby non-skilled personnel.As discussed at the conference by Dr. Mark Fukuda,chief of the department of immunology & medicine at theArmed Forces Research Institute of <strong>Medical</strong> Sciences(Bangkok, Thailand), dipstick tests for malaria-specificantigens are available at prices ranging from 60 cents to$2.50 (vs. a cost of 12 cents to 40 cents for microscopy), butsuch tests cannot differentiate lethal vs. non-lethal formsof the parasite that causes malaria. A new immunochromatographictest developed by Binax (Scarborough,Maine), the Malaria P.f./P.v. NOW ICT, provides subtyping ofthe parasite using a fingerstick blood sample. The testtakes 20 minutes to perform, and the required skill level islow. However, sensitivity is considerably less thanmicroscopy at over 100 parasites per microliter vs. 50 formicroscopy.Nucleic acid amplification tests for malaria havebeen developed for research use, and look promising,since sensitivity is less than 5 parasites per microliterand all subspecies can be detected, but at present suchtests are research tools, not clinical products. Real-timePCR tests have been evaluated by Fukuda that appearpromising, and that can potentially allow therapy to bemonitored. However, he said he believes that antigencapture or immunochromatographic methods will proveto be the best methods for future malaria diagnostic testing.See Asia, Page 10To subscribe, please call DIAGNOSTICS &IMAGING WEEK Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited.


THURSDAY, MARCH 2, 2006 DIAGNOSTICS &IMAGING WEEK PAGE 10 OF 13AngiographyContinued from Page 1In a recent article in the Los Angeles Times, Dr. C. NoelBairey Merz of Cedars-Sinai <strong>Medical</strong> Center (LosAngeles) said, “One of the biggest take-home messagesfrom this study is that we must stop falsely reassuringwomen when their arteries are open.”Instead of large blockages, postmenopausal womenare more prone to a condition that leads to a narrowing ofthe microvasculature throughout the coronary artery system,rather than a large clump of plaque in one artery thatcan easily be seen with angiography.“The WISE study has further demonstrated thatmicrovascular ischemia is frequently associated with thesigns and symptoms of this large cohort of women withnonobstructive coronary arteries,” the researchers said.That’s important to know, since more than a quarter ofa million women die each year in the U.S. from ischemicheart disease “and its related conditions, and current projectionsindicate that this number will continue to rise withour aging population.”Specifically, according to the State-of-the-Art portion ofthe series, the Duke Activity Status Index (DASI), a 12-questionself-report, “provides valid information predictive ofadverse cardiovascular outcomes . . .”“Perhaps this instrument, if validated in other femalepopulations, should be administered in the office as a partof our diagnostic evaluation,” according to the study introduction.The study also suggested that exercise testing on atreadmill to increase heart rate, often called “stress testing,”may be questionable when it comes to its ability to predictadverse events in women.Also, the study suggests that using positron emissiontomography (PET) and MR may work better than the currentlyused single-photon emission computed tomography(SPECT) testing in women.The study said that because SPECT perfusion techniquesmeasure deficits based upon “differences inregional distribution of blood flow that is comparativelyassessed . . . across the myocardium,” it is possible that “inthe setting of global coronary vascular dysfunction(endothelial or microvascular dysfunction), the SPECTstudy could show no regional differences in the distributionof flow and appear normal,” even when there wascause for concern.However, researchers also suggested that the preferreduse of PET and MRI had yet to be established in thecurrent literature.The study said, “recent estimates from the Centersfor Disease Control and Prevention [CDC; Atlanta]reveal that 38% of all deaths in women are related to coronaryheart disease, as compared with 22% resulting fromcancer.“Indeed, since 1984, more women than men have diedannually from IHD, refuting the notion that this is a ‘man’sdisease’ and suggesting that it might be relabeled a‘woman’s affliction,’” according to the State-of-the-Art portionof the study.The goal of the studies is to create a “heightenedawareness of women at risk of IHD and a different approachthan that used in men, [which is] necessary to allowfor diagnosis before late stages develop,” the introductionreported.The study also offers some instruction of its own, suggestingthat with the information gleaned from the WISEstudies, “consensus need to be reached on an algorithm ofdiagnostic testing to better assure an accurate early diagnosisof IHD.”As the number of women dying from ischemic heartdisease outpaces men, there is a suggestion that additionalresearch must focus on “gender-specific issues” in order toaddress the societal burden and costs related to thesedemographic shifts in IHD that place women in the majorityof those impacted.”For example, there are differences in the way womenwho are menopausal vs. premenopausal respond to varioustesting methods.“This significant burden of the disease in womenplaces unique diagnostic, treatment and financial encumbranceson our society that are only further intensified bya lack of public awareness about the disease on the part ofpatients and clinicians alike.” ■AsiaContinued from Page 9Other important infectious disease testing applicationsin Asia include detection of Dengue infection andtracking transmission of Avian flu viruses (HN51). As discussedby Dr. Bijan Kumar Sil of the National EnvironmentAgency, Environmental Health Institute (Singapore), anumber of tests for dengue virus have been developed byhis laboratory that use monoclonal-based competitiveELISA, real-time PCR or antigen ELISA to detect dengueinfections at various stages of the disease, improving theability of public health agencies to monitor infection outbreakswithout the need for cell culture facilities.Dr. Sze-Wee Tan, CEO of Rockeby Biomed Ltd. (Singapore),described a new rapid test for Avian flu that wasintroduced by his company last November. Rockeby hasdeveloped additional tests for vaginal infection in partnershipwith Pacific Biotech (Thailand). The existing Avianflu test is designed for testing of birds, and has been usedin Southeast Asia, the Middle East, Eastern Europe andJapan. A human test also has been developed. The marketfor a human test, however, is very small due to the fact thatonly a few cases have so far been diagnosed. That situationcould change if the virus mutates and begins to generate ahuman pandemic. ■To subscribe, please call DIAGNOSTICS &IMAGING WEEK Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited.


THURSDAY, MARCH 2, 2006 DIAGNOSTICS &IMAGING WEEK PAGE 11 OF 13InternationalContinued from Page 1human health and give real help to business creation at thetime when entrepreneurs most need it.”CDC Entreprises is the equity capital arm of the Frenchgovernment’s bank, Caisse des Dépôts et Consignations,and manages funds totaling EUR 4.2 billion, half of which isinvested by CDC itself. Sonfinnova Partners is an independentventure capital fund set up in 1998, which currentlymanages investments totaling EUR 900 million, whileVentech was spawned by Natexis Private Equity, a subsidiaryof Natexis Banques Populaires, and manages investmentsof EUR 173 million divided between two funds.MedMira signs Dutch distributor for HIV testMedMira (Halifax, Nova Scotia) said it has signed a distributionagreement with Clindia Benelux of the Netherlandsfor the MiraCare Rapid HIV Antibody Test. Clindia willbegin sales of the rapid test in late March.Initially, MedMira’s instant HIV test, which detects antibodiesin whole blood, serum and plasma, will enter themarket via hospitals and public health clinics, where demandis highest.“Clindia has an excellent reputation and solid experiencein diagnostic sales to the healthcare market. We remainexcited about the overall potential in Europe and now theopportunity to develop current and future markets for instantHIV tests in the Netherlands with Clindia,” said Giles Crouch,vice president of global sales and marketing for MedMira.The company said the Netherlands will be an importantentry point for MiraCare HIV into the European over-thecounter(OTC) market, since healthcare advancements suchas OTC rapid HIV tests “are more readily accepted by thecountry’s healthcare system and consumer population.”“To finally have a reliable and instant HIV test availablein the Netherlands is an asset to our healthcare system,”said Clindia CEO Peter Langens. “MedMira’s reputation forquality and their strong technical support team will be ofgreat help as we work together to grow the market.”Two more countries add Zonda testsZonda (Moraga, California), which is focused on developmentof test products that serve the medical diagnostic,bacterial food testing and environmental surfaces testingmarkets, reported that it has received the first order for itsHandiLab-C chlamydia test for Holland and Belgium.The order for the over-the-counter version of theHandiLab-C test, which will be distributed to pharmaciesand other retail locations throughout Holland and Belgium,will be shipped along with re-orders that were placedrecently for Swedish and Norwegian pharmacies.Zonda said its HandiLab-C test is the only over-thecounterchlamydia test that carries the CE mark.Tammy Dunn, CEO of CLX Investment Co. (TemeculaCalifornia), which holds a 31% equity interest in Zonda, said,“With the addition of Belgium and Holland, the distributionof Zonda’s products continues to grow, as do the revenuesfrom the sale of these products across Europe. We arepleased with the progress that has been made with expandingproduct distribution in a relatively short period of timeand look forward to additional countries being suppliedwith Zonda testing products over the coming quarters.”Zonda’s gonorrhea, yeast and Strep A tests carry CE marksfor professional point-of-care use, and Zonda is seeking similarapprovals for over-the-counter sales of those products.Radiology meeting features DOBI systemDOBI <strong>Medical</strong> International (Mahwah, New Jersey)said it would exhibit its latest Dynamic Optical BreastImaging (DOBI) technology, the ComfortScan system, at theEuropean Congress of Radiology, which begins Friday andruns through next Monday at the Austria Center Vienna.Participants from more than 90 countries are expectedto participate in the 18th annual conference, which is one ofthe most prominent radiology events in Europe andaccording to the organizers is one of the largest scientificmeetings in the world.According to the European Network of Cancer Registries,breast cancer is the most common cancer amongfemales in Europe and is estimated to be responsible for18% of all cancer deaths in Europe.The ComfortScan system is a near-infrared-based, noninvasiveand non-ionizing imaging system designed to beused along with mammography to improve the diagnosisof breast cancer, by identifying tumor angiogenesis, or thegrowth of new blood vessels, often associated with cancer.DOBI said it has distribution agreements in place in 16countries, and several others pending. Its European distributionnetwork includes the Czech Republic, Switzerland,Italy, Greece, the Netherlands and Russia.The ComfortScan system has CE-mark and UL designations,and DOBI <strong>Medical</strong> is an ISO-certified company.More distributors for DiaSysDiaSys (Waterbury, Connecticut) said it has signedthree-year exclusive distribution agreements with RochemBiocare for territories that cover Colombia, Peru, Ecuadorand Panama.The agreements guarantee minimum orders of $1.46million for the company’s parasitology and urine sedimentworkstations and consumable products over the periodcovered by the agreement.Jose Puig, sales manager, Latin America, for Diasys,said, “In addition to our recent agreement in Mexico andthe award in Venezuela, these new transactions provideDiaSys with a network of capable, experienced diagnosticdistributors in each market.”DiaSys manufactures laboratory equipment, consumablesand infectious disease test-kits to healthcare and veterinarylaboratories worldwide. ■To subscribe, please call DIAGNOSTICS &IMAGING WEEK Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . 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THURSDAY, MARCH 2, 2006 DIAGNOSTICS &IMAGING WEEK PAGE 12 OF 13B RIEFLYN OTEDUT Imaging opens in HoustonUT Imaging (Bellaire, Texas), a partnership between UTPhysicians, the medical practice of the University of Texas<strong>Medical</strong> School at Houston, and Outpatient ImagingAffiliates (Nashville, Tennessee), has officially opened.UT Imaging provides MRI and computed tomographyscans, ultrasound studies, X-rays and DEXA for bone densitymeasurement. In addition to advanced diagnosticimaging equipment, UT Imaging offers wide sub-specialtymedical expertise, provided by UT radiologists, and quickreport turnaround times.UT Imaging also offers physicians a secure and convenientway to access information about the status ofpatients referred to UT Imaging for imaging studies.Through its referring practice web portal, UT Imaging providesreal-time, secure and convenient access to patientreports and images - both current and historical - as well aspatient appointment availability and status.“UT Imaging will expand our faculty’s scope of clinicalpractice and make their specialized expertise more widelyavailable to Houston-area patients and physicians,” said Dr.Susan John, professor and chair of the department of diagnosticand interventional imaging at the University ofTexas <strong>Medical</strong> School.Accuray expands facilitiesTo meet the growing worldwide demand for itsCyberKnife Robotic Radiosurgery System, robotic radiosurgerymanufacturer Accuray (Sunnyvale, California) reportedthe opening of an expanded manufacturing facilityin Sunnyvale. The facility immediately doubles Accuray’sproduction capacity and is sized to support the company’sgrowth over the next decade, it said.In addition, the company strengthened its internationalpresence by opening expanded regional offices inParis and Hong Kong to address the surge in sales andinstallations of the CyberKnife System worldwide.“Accuray’s global expansion is further evidence that theCyberKnife System is recognized as an essential tool in thefight against cancer, treating tumors anywhere in the body,”said Euan Thomson, PhD, president and CEO of Accuray.Accuray’s expanded manufacturing plant strengthensthe company’s R&D efforts. The new facility enablesAccuray to accelerate the pace of product development andto continue to bring the latest innovations in robotic radiosurgeryto current and future CyberKnife customers, it said.The company also opened a new training center inFebruary. The center is located in Accuray’s corporateheadquarters in Sunnyvale and allows the company to providemore clinicians with the critical information requiredto make radiosurgery an option for every cancer patient.VivoMetrics to conduct space sleep studyVivoMetrics (Ventura, California), in partnership withthe University of Limerick and with sponsorship fromthe European Space Agency, said it would be conducting astudy to evaluate and determine the quality of sleep ofastronauts while in orbit, with the goal of providing ahealthier sleep environment for astronauts in the future.As part of the study, Thomas Reiter, a German astronaut,will wear the VivoMetrics LifeShirt System aboard theInternational Space Station, after traveling there on theDiscovery Space Shuttle later this year.In the experiment, astronauts will wear the lightweight,machine-washable garment with embedded sensorsto record sleep activity by assessing cardiac activityfrom an electrocardiogram and other physiological parameters.They will use an integrated PDA to answer a series ofsleep-related questions as part of a subjective “sleep diary.”Analysis software will then produce a sleep spectrogramthat researchers will use to measure the astronauts’ stabilityof sleep.VivoMetrics describes the LifeShirt as the first noninvasive,ambulatory monitoring system that continuouslycollects, records, and analyzes a broad range of cardiopulmonaryparameters.HealthTronics opens anatomical pathology labHealthTronics (Austin, Texas) reported that it hasopened its anatomical pathology laboratory, which has asits primary focus service to the urology community. Thelab is located in a life sciences building on the campus ofthe <strong>Medical</strong> College of Georgia (Augusta, Georgia).John Barnidge, interim president and CEO, said, “Ourcustomers and physician partners will benefit from technologicalinnovations, including web-based reporting capabilitiesand bar code assisted workflow. With input from ourphysician partners, we have also developed a unique,patent-pending biopsy kit to maximize efficiencies andquality assurance for both the physician and lab personnel.”HealthTronics provides healthcare services primarilyto related to urology in addition to making medicaldevices. The company also manufactures specialty vehiclesused for the transport of high-technology medicaldevices and broadcast and communications equipment.Digital X-ray units gaining acceptanceWith the wealth of clinical applications and diverse systemschoices, digital X-ray units are steadily gaining acceptanceby technologists and physicians alike for the ease ofuse of digital images over film-based X-ray, according to astudy by Frost & Sullivan (Palo Alto, California).Though system prices still limit wide-scale market penetration,manufacturers are responding with decreasingselling prices annually as well as offering a range of systemsthat can benefit both large hospitals and smaller privatepractice groups, the study reported.To subscribe, please call DIAGNOSTICS &IMAGING WEEK Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited.


THURSDAY, MARCH 2, 2006 DIAGNOSTICS &IMAGING WEEK PAGE 13 OF 13P RODUCTB RIEFS• Clinical Data (Newton, Massachusetts), which iscommercializing pharmacogenomics to guide drug utilization,reported that its Vital Diagnostics division has receivedFDA clearance to market a wide-range C-reactive protein(wrCRP) assay, trademarked as the Nanopia wrCRPAssay. The Nanopia wrCRP is an in vitro diagnostic used forthe quantitative measurement of C-reactive protein inserum or plasma. C-reactive protein is a blood componentthat increases rapidly in infections, tissue trauma, surgeryor other injury to the body.• Dade Behring (Deerfield, Illinois) reported that it haslaunched the Cyclosporine Extended Range test for use onits Dimension family of chemistry analyzers and the V-Twinand Viva-E drug testing analyzers. The CyclosporineExtended Range test, or the C2 monitoring test, is a new,more clinically sensitive method used to monitorCyclosporine in transplant patients. It is monitored withintwo hours of patients having ingested the immunosuppressantdrug, which some studies have shown to be a betterpredictor of patient outcome. Dade Behring said itwould continue to offer the original Cyclosporine test. TheP EOPLE IN P LACES• Eastman Kodak (Rochester, New York) has namedtwo vice presidents in health solutions-related units. DavidKiser has been named director and vice president, health,safety and environment, and Anne LeGrand general manager,output systems and mammography solutions inKodak’s Health Group. Kiser joined the company in 1981, andtoday leads Kodak’s global emphasis on sustainability andhealth, safety and environmental stewardship as directorsince 2004. LeGrand joined Kodak in 1999 and assumed hercurrent position in January. She previously worked asregional business general manager, greater Asia region, forcompany said its two Dimension Cyclosporine tests are theonly automated Cyclosporine tests on the market, requiringno manual pretreatment steps.• SenoRx (Aliso Viejo, California), which makes minimallyinvasive devices for the diagnosis and treatment ofbreast cancer, reported that it has made available a new 7-Gauge size probe for its recently launched breast biopsydevice, EnCor. EnCor probes were previously only availablein a 10-gauge size. According to the company, EnCor is thefirst fully programmable, automated, multi-modality, modularbreast biopsy system available, and is the first thatoffers the benefits of both open and closed tissue collection.• Stereotaxis (St. Louis) reported that Central BaptistHospital (Lexington, Kentucky) became the first U.S. centerto treat a patient’s cardiac arrhythmia using the company’spartnered 3-D Localized Ablation Catheter. This diagnosticand ablation catheter recently received FDA approval foruse with the Stereotaxis Niobe Magnetic NavigationSystem. The company said the approval provides StereotaxisNiobe system users in the U.S. with 3-D localizationof the catheter tip, a function that offers physicians preciseand efficient control of the catheter tip with constant feedbackas to the exact location of the catheter in theanatomy.Health Imaging, with responsibility for the business across22 countries. She also was regional business general manager,EAMER for Health Imaging. In October 2005, shebecame general manager, digital output systems, HealthGroup.• L. David Tomei, PhD, co-founder of Xenomics (NewYork), has been appointed CEO of the company. Tomei willremain in his post as co-chairman. He replaces former CEORandy White, PhD, who has left the company to pursueother interests. The company said the appointment ofTomei to the senior management position is the latest stepin its strategic plan to commercialize its Transrenal-DNA(Tr-DNA) technology as a basis to develop a suite of noninvasive,DNA-based diagnostic tests for a range of majordiseases, genetic disorders and other serious healthcareconditions. Tr-DNA can be obtained through urine samples.REPRINTS?For high-quality reprints of articles about your company that have appeared inDiagnostics & Imaging Week, please call Stephen Vance at (404) 262-5511,or e-mail him at stephen.vance@thomson.comTo subscribe, please call DIAGNOSTICS &IMAGING WEEK Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited.

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