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78 Luminex gets 510(k) clearance for xTAG cystic fibrosis test By LYNN YOFFEE Medical Device Daily Staff Writer Luminex (Austin, Texas) reported that it has received FDA 510(k) clearance for a new cystic fibrosis (CF) test: the xTAG Cystic Fibrosis 39 Kit v2, which is designed to detect the 39 CF-causing gene mutations. It is used to screen potential parents to determine if they are carriers of CF mutations, as an aid in newborn screening and in confirmatory diagnostic testing in newborns and children. This test is actually a new, improved version for Luminex. The first iteration was cleared by the FDA in 2005. “Compared to the previous version, this is faster and requires less labor,” Jeremy Bridge-Cook, PhD, senior VP, Assay Group at Luminex, told Medical Device Daily. “The previous version took about 6.5 hours and this version takes about 4.5-5 hours depending on the model of thermocycler used. And the labor time goes down from one hour and 20 minutes to 50 minutes. The second difference is that the previous versions of the product recommended which enzymes to use, but didn’t provide them. In this version, all of the reagents needed are incorporated in the kit.” There are about 70,000 people worldwide who have the disease with 30,000 in the U.S. There is no cure and the median predicted age of survival is 37.4 years, according to the Cystic Fibrosis Foundation (CFF; Bethesda, Maryland). CF is inherited from parents who carry the mutated genes but are not sick with the disease. It causes mucus to build up and clog the lungs, making it difficult to breathe. That sticky overproduction of mucus can also cause bacteria to stick to airways, leading to infections and lung damage. But the problems with CF don’t stop in the lungs. Mucus can also affect the digestive tract and pancreas, wreaking havoc on the body’s ability to digest nutrients. It is caused by mutations in the CF transmembrane conductance regulator (CFTR) gene. More than 1,500 such mutations have been identified to date. Carrier screening is recommended for couples planning a pregnancy as it is possible for a person to carry a CFcausing gene mutation and have no symptoms of the disease. CFF reports that more than 10 million Americans are symptomless carriers of a CFTR gene mutation. Early diagnosis of CF in babies allows for earlier treatment intervention and can help improve a child’s long-term health and quality of life. With no cure in sight, the value of a test can be put to question. But Bridge-Cook said that prospective parents should be tested because, “If both parents have a CF mutation, there’s a one in four chance that a baby would have CF. The utility of information in that context is that it enables people to make more informed choices from a reproductive MEDICAL DEVICE INNOVATION 2010 standpoint. “The other intended indication for the tests is as an aid in diagnosis of newborns,” he said. “Babies who are diagnosed early do better and live longer than kids who are diagnosed later. One of the other aspects of CF is pancreatic insufficiency. That condition means babies or young children with CF start to have digestive problems. If its diagnosed early, dietary measures can be taken that lead to much better outcomes and longer survival.” The xTAG Cystic Fibrosis 39 Kit v2 screens for the 23 CFTR gene mutations and four variants (polymorphisms) recommended by the American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG), and 16 additional CFTR gene mutations from human blood specimens in a few hours. The xTAG Cystic Fibrosis 39 Kit v2 offers physicians the ability to select the CFTR gene mutations for which they want to test. Doctors can choose to test a patient for the 23 ACMG/ACOG-recommended gene mutations or the entire panel of 39 CFTR gene mutations. This newer version of the xTAG Cystic Fibrosis 39 Kit v2 will allow labs to avoid having different platforms for various testing purposes and save time and resources. And like the first generation xTAG CF test, the new xTAG Cystic Fibrosis 39 Kit v2 does not require reflex testing. All results are revealed and available for analysis at each run, if necessary. Although Bridge-Cook would not discuss the cost of the test, he did say that CPT coding for reimbursement is well established and that the cost of the tests is less than the current reimbursement level, making it “fairly attractive.” Earlier this year Luminex launched the xTAG Cystic Fibrosis 39 Kit v2 and xTAG Cystic Fibrosis 71 Kit v2, as CEmarked in vitro diagnostics under the European Directive on In Vitro Diagnostic Medical Devices. According to the European Cystic Fibrosis Society, as many as one in 30 Europeans are carriers of a CF-causing gene mutation. The xTAG Cystic Fibrosis 71 Kit v2 can screen for all of the genetic mutations in the xTAG Cystic Fibrosis 39 Kit v2 plus an additional 32 mutations including those that are typically found in specific ethnic populations (MDD, June 11, 2009). Bridge-Cook said a version of the xTAG Cystic Fibrosis 71 Kit is on the way for FDA review and U.S. launch. (This story originally appeared in the Sept. 8, 2009, edition of Medical Device Daily) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
MEDICAL DEVICE INNOVATION 2010 Luminous still in 510(k) path with glucose monitor By OMAR FORD Medical Device Daily Staff Writer Imagine being the CEO of a small med-tech company with a surefire product and nearly $35 million in venture capital. The company is all set to get the green light from the FDA and start clinical trials. Then it happens. The FDA throws the company a curveball and says that the technology the company is appropriating isn’t something they’ve dealt with before and they’re not quite so sure how to evaluate it. The chances of a 510(k) diminish and a PMA seems to be the only option. It’s a scenario that small startup Luminous (Carlsbad, California) faced when it went to get approval for its automated glucose monitor. Previously, Luminous was planning to use a sensing technology based on near-infrared spectrometry. Infrared spectrometry was untested waters when it came to using a glucose monitor, so that’s where the issue came with the FDA, the company said. “The technology worked,” Dave McMahon VP of Marketing for Luminous told Medical Device Daily. “We went and met with the FDA over a year ago about the device. The outcome was that [FDA] said this is technology that they weren’t sure how to evaluate. They also told us that if we went that route it was going to be a pretty large clinical trial that was needed to show efficacy of the device. The bottom line was that we could go ahead and file the device for a 510(k) application but it sounded like we would have had to take the PMA route and a PMA wasn’t in our timeline. Fortunately for us we had a backup plan.” That plan included a deal with a major supplier (that the company hasn’t yet revealed) of electrochemical sensors for exclusive rights to incorporate its glucose sensor into Luminous’ automated blood glucose monitor. This sensor has already been FDA-approved and would put Luminous in a better position to get its entire product approved. As of press time the company had not settled on a name for the device. “It was not an easy decision for us to make,” McMahon said. “The company was founded on this technology. Luminous said that it is preparing for pivotal clinical trials and a 510(k) application in 2010. If the company has favorable results in trials and gets an FDA approval, it plans to launch the device at the end of 2010. Glucose oxidase electrochemistry has been used to measure glucose with near laboratory accuracy in point-ofcare devices for many years. The FDA has recently expressed concern about the use of test strip-based glucose meters that are not cleared to manage glucose in hospitalized patients. The Luminous product is being designed to automate the process of glucose monitoring while simultaneously raising the bar for measurement accuracy at the point of care. And it has had significant support in funding to do so. Last year Luminous reported completing a $23.5 million round Series B financing. Adams Street Partners led the investment, joined by new investors RiverVest Venture Partners, and Finistere Ventures. Existing investors De Novo Ventures and Latterell Venture Partners also participated in the round. The company previously completed a $9 million round of Series A funding in 2005. “We’re seeking a Series C round in 1Q10 to get us onto the market,” McMahon told MDD. To further garner support for the device Luminous will be displaying it at the Society of Critical Care Medicine’s (Mount Prospect, Illinois) Post-Congress Conference to be held in Key West, Florida from January 13th January 15th, 2010. If successful the company could become a huge player in a market with a strong clinical demand for glycemic control. To date, multiple clinical studies have demonstrated significant morbidity and mortality benefits from controlling glucose levels in critical care patients. As a result, clinicians have rapidly adopted glycemic control procedures but struggle with inadequate and time consuming manual methods. The device would eliminate these time consuming methods and eliminate a lot of human error introduced into the process the company says. (This story originally appeared in the Oct. 19, 2009, edition of Medical Device Daily) 79 To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
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