IVDT_In Vitro Diagnostics Technology

IVD Technology, Spring 2013

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trends & perspectives their instruments and IT systems, and the IICC has been working to refne the LAW. Adoption of the LAW interface will provide a plethora of benefts to all stakeholders in the feld of laboratory medicine and beyond, notes the IICC. Te consortium cites error reduction, enhanced patient care, more streamlined specimen through- put, and improved data fow to hospital information and other IT systems among the advantages. Additionally, the LAW interface will assist in regulatory compliance with rules such as Meaningful Use (MU). Te IICC's success in development of the LAW has led to further challenges, including addressing LOINC code standardization to comply with MU2. A global, nonproft organization founded in 2008 by industry leaders and the clinical laboratory community, the IICC's mission is to create and ensure the adoption of a unifed connectivity standard. To schedule one-on-one meetings with the organization at the AACC Annual Meeting, contact Jean Rhame via e-mail at jrhame3@gmail.com. Your Osteoporosis Test Is in the Nail Consumers worried about their risk for osteoporosis soon will have a new resource at their fngertips. By the end of Q2 2013, Crescent Diagnostics (Dublin) will launch its Bone Quality Test (BQT), which measures keratin levels in nail clippings as a surrogate marker for collagen, an indicator of Brendan Farrell bone quality. Te consumer-to-lab kit initially will be available in Ireland and the United Kingdom, with other European markets, notably Germany and Sweden, to follow. Te test will allow people to assess their risk of contracting osteoporosis in a simple, cost-efective way, says CEO Brendan Farrell, and is not designed to replace traditional tests, such as DXA. But that was not always the case. "Initially, we were looking to mimic DXA scanning," says Farrell. "But our test predicts the probability of having an osteoporosis-related fracture in the next 10 years by means of a statistical linkage between the integrity of the keratin molecule and osteoporosis," he explains. DXA screenings are costly and conducted in clinical settings, and it became apparent that it made more commercial sense to market BQT directly to consumers who could then determine if they are at risk and, if so, seek further medical attention. "We reposiivd tech n o lo gy.com magenta cyan yellow black tioned ourselves in the last six months or so as a pre-DXA test," says Farrell, who adds that the growing ranks of people at risk for osteoporosis will create demand for an inexpensive DXA prescreening tool. BQT combines two technologies in a novel way, at least in the IVD space, says Farrell. Te consumer buys the kit at the local pharmacy and mails a nail clipping to the lab using the included vial and prepaid envelope. Te lab inserts the clipping into a Raman spectrometer, where the sample is excited and produces a spectrum. Proprietary algorithms tag the sample according to the osteoporosis risk. "Te lab reports back to the patient using a simple greenamber-red type of system," says Farrell. "Green means you're fne; amber means you are at risk of osteoporosis and might consider making some lifestyle changes; red indicates that you could have a problem and should see your general practitioner." Te test itself takes about four minutes of lab time and the cost to the consumer will be in the neighbourhood of £39 (approximately $60). A DXA scan, by contrast, requires the services of a clinician, can take up to one hour, and costs around £200 ($300). Osteoporosis is often called the silent disease because people frequently don't know they have it until they break a bone, at which point they will have lost signifcant bone strength and are at risk for more fractures. "Te condition is underdiag- nosed and undertreated," says Farrell, and it is largely preventable if treated early. It is also a huge economic burden on healthcare systems. In the United Kingdom alone, the combined annual cost of hospital and social care for patients with hip fractures is estimated at £2.3 billion ($3.5 billion), according to a number of national studies. In the United States, more than 10 million people have been diagnosed with the disease, and 34 million more are at risk of developing it. Faced with such numbers, a Surgeon General's report from 2004 declared the disease had reached epidemic proportions. Tere are currently no plans to market the BQT in the United States, however. "You don't see consumer-to-lab tests in the United States. Te tests you do fnd in drugstores tend to be self-test types of products," says Farrell. Consequently, while he is not ruling out launching the kit across the pond, it is low on his list of priorities. Te United States is not completely of his radar, however. Farrell has been known to beat a path to Laramie, Wyoming, where the U.S. manufacturer of the Raman spectrometer that Crescent uses is developing a desktop version of the test using the algorithm. "A prototype is well underway," says Farrell. "It is the length and width of an iPhone, although substantially thicker. If they can get the cost low enough, the device could end up in physicians' ofces." ––Norbert Sparrow IVD i vd t ec H n O LO G Y | s pr i nG 2 0 1 3 1 1 ES236959_IV1305_011.pgs 04.24.2013 23:37 UBM

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