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There has been a recent influx of U.S. Food and Drug Administration (FDA) approvals in the in-vitro diagnostics market. Here is a rundown of some of the new developments.
Biophor Diagnostics, Inc. announced that they received FDA 510(k) clearance for sale and distribution of its seventh oral fluid screening assay based on the RapidFRET® IVD Platform technology. This clearance completes the company’s flagship panel for drugs of abuse screening in oral fluid.
“We are extremely pleased to reach this significant milestone for the company and for oral fluid drug testing. Biophor’s RapidFRET IVD Platform raises the bar for accuracy and efficiency of in vitro diagnostic solutions and is a versatile system for continued IVD development,” said Dr. Todd Corneillie, President of Biophor.
Cepheid announced that it has received clearance from the FDA to market Xpert® TV, a qualitative in vitro diagnostic test for accurate and reproducible identification of Trichomoniasis in symptomatic and asymptomatic female patients, using urine, endocervical swab or vaginal swabs collected by the patient in a clinical setting. Xpert TV becomes the 18th test available to run on Cepheid’s GeneXpert® System in the US, and is an important addition to the Xpert women’s health portfolio which already includes Xpert CT/NG, Xpert Group B Strep and Xpert HPV.
“The commercial launch of Xpert TV is particularly timely given the CDC’s recently revised recommendation to use highly sensitive and specific NAAT testing for the detection of Trichomonas vaginalis in both symptomatic and asymptomatic patients,” said David Persing, M.D., Ph.D, Cepheid’s Chief Medical and Technology Officer. “Xpert TV provides reference laboratory levels of performance in an on-demand, easy to use format. For the first time, clinicians can offer same-day consultation and treatment for TV, with results available in about an hour, in most cases.”
Avant Diagnostics, Inc., an in vitro diagnostics company, was notified by DOCRO, its independent clinical research organization, that it has received notification that the previously purchased specimens have been approved and are available for use in the forthcoming validation study to be used to support a pre-Submission package to the FDA.
Gregg Linn, Avant’s Chief Executive Officer and President, noted, “Avant continues to make steady progress towards its goal of obtaining FDA 510(k) clearance for OvaDx®. We intend to periodically communicate with our shareholders and markets as we progress through the FDA negotiations and through FDA’s review of our 510(k) submission.”
The FDA has given BioFire Diagnostics a de novo clearance for the FilmArray Meningitis/Encephalitis Panel. This panel is designed to address the need for quick and accurate identification of central nervous system infectious agents by using a comprehensive panel to test cerebrospinal fluid for the 14 most common pathogens responsible for community-acquired meningitis or encephalitis in about an hour. Now, testing CSF for multiple organisms is not always possible because it can be difficult to obtain enough fluid from each patient to run multiple tests.
“The ME Panel highlights the clinical impact the FilmArray brings to infectious disease testing,” Randy Rasmussen, BioMerieux corporate vice president of molecular biology and BioFire Diagnostics CEO, said in the statement. “It quickly and efficiently provides physicians complex diagnostic information, helping them to rapidly diagnose severe infections.”
For Further Information
More on the in vitro market in the U.S. can be found in the report series published by iData entitled US Market for In-Vitro Diagnostics Report Suite – 2016. This report covers the U.S. market segments for the Immunochemistry Market, Molecular Diagnostics Market, Molecular Blood Donor Screening Market, Hemostasis Market, Hematology Market, and Point of Care Diagnostic Device Market.
Full reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment.
Register online or email us at [email protected] for a US Market for In-Vitro Diagnostics Report Suite – 2016 report brochure and synopsis.
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