INSIDE: - Medical Device Daily

More documents

Recommendations

Info

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 MedicalDeviceDaily.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 Medical 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.
Page 1 and 2: DIAGNOSTICS & IMAGING WEEKT HE W EE
Page 3 and 4: THURSDAY, MARCH 2, 2006 DIAGNOSTICS
Page 7: THURSDAY, MARCH 2, 2006 DIAGNOSTICS
Page 13: THURSDAY, MARCH 2, 2006 DIAGNOSTICS

INSIDE: - Medical Device Daily

Create successful ePaper yourself

Delete template?

Save as template?