Trends & Perspectives
Your Osteoporosis Test Is in the Nail
  Consumers worried about their risk for osteoporosis soon will have a new resource at their fingertips. By the end of Q2 2013, Crescent Diagnostics' CEO Brendan Farrell 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 bone quality. The consumer-to-lab kit initially will be available in Ireland and the United Kingdom, with other European markets, notably...
Idaho Technology Becomes BioFire Diagnostics, Advances Clinical Diagnostics Goals
The former Idaho Technology Inc. now sports a new name and a new logo. The former Idaho Technology Inc., a Salt Lake City−based manufacturer of diagnostics for the clinical, biodefense, and research markets, has renamed itself BioFire Diagnostics Inc. and is in the process of rebranding, a task vice president of sales and marketing Rachel Jones estimates will take 12 months from start to finish. The company was formed in Idaho Falls, Idaho, in 1990 but moved to its current...
European Commission Publishes Guidance on Medical Software Used in IVDs
The decision tree is designed to assist manufacturers in the qualification of stand-alone software as an IVD device. The European Commission recently published “Guidelines on the Qualification and Classification of Stand Alone Software Used in Healthcare within the Regulatory Framework of Medical Devices.” The MEDDEV guidance document addresses all of the medical device directives and includes two convenient decision trees to determine whether particular software is...
Ventana Strikes Numerous Deals With Pharma Firms This Year
The INFORM HER2 Dual ISH DNA Probe cocktail assay was approved as an aid in the assessment of patients considered for treatment with Herceptin (trastuzumab). Image: Roche Among the American IVD manufacturers working to make personalized medicine a day-to-day reality in healthcare, none appears busier than Ventana Medical Systems in Tucson, Arizona. Since the beginning of 2012, Ventana, a Roche company, has made six announcements (at last count) of collaborations with...
Our Most-Read Story of 2012: U.S. IVD Market to Exceed $9.5 Billion by 2017
Molecular diagnostics, POC diagnostics, and hematology are expected to see continued growth. The current IVD market includes immunochemistry, molecular diagnostics, blood donor screening, hematology, hemostasis, and point-of-care testing. As the IVD market evolves to become more efficient and less costly, a shift from manual testing to automated methods is essential. Furthermore, as patient care shifts from the hospital to the alternate care setting, IVD is likely to follow. Overall...
Bill proposes modernizing IVD regulations
Congressman Leonard Lance (R-NJ) introduced legislation to promote the development of meaningful treatments for patients with chronic or rare diseases. The “Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network (MODDERN) Cures Act” (HR 3497) would modernize the U.S. drug and diagnostics evaluation and regulatory network by encouraging the discovery and development of new treatments for the many diseases that have few or no options. It would also create a...
FDA To Exempt Some IVDs from 510(k) Clearance
Late last year, FDA issued its guidance for industry and FDA staff titled “Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.” In the guidance document’s introduction, FDA states that it proposes the “downclassification” and exemption from 510(k) requirements of the Class II devices that are the subject of the document because the safety and effectiveness of those devices is sufficiently...
Report offers insights into IVD M&A activity
Last December, PwC released a new report, “Diagnostics 2011: M&A Surges, Companion Diagnostics Accelerate, and Early Detection Offers New Prospects.” This report provides an overview of merger and acquisition deal activity in the IVD industry during the past two years and the factors driving it, an assessment of the development of new prospects for early detection testing, and a review of significant events for the development of personalized medicine. The report also...
Samsung Electronics Lengthens its Dx Reach
Samsung Electronics Company, Ltd., a globally recognizable brand of semiconductor, telecommunication, digital media, and digital convergence technologies based in Seoul, South Korea, has acquired the Nexus division of ITC Nexus Holding Company (ITC), a provider of cardiac point-of-care testing products. Nexus, based in San Diego and founded not quite three years ago, manufactures and markets the Cardiac STATus, DECISION Point, and VYENT lines of rapid test kits that aid in the diagnosis and...
OCD’s “Know Your Numbers” campaign pushes forward
Ortho Clinical Diagnostics (OCD), in partnership with the National Association of Chronic Disease Directors (NACDD), published consumer-survey results and a report revealing the state of blood test health literacy in the United States, with strategies to support patient education and empowerment. The survey and report are part of the Know Your Numbers campaign, which was launched in conjunction with National Health Literacy Month last year. Among the survey’s findings were that nearly 90...