NEWS

   Download PDF        
October 19, 2015

FOR IMMEDIATE RELEASE

Lumiphore's Partner, Biophor Diagnostics, Inc. Receives 7th FDA 510k Clearance for Drugs of Abuse Assays

Biophor Diagnostics, Inc. (http://www.biophor.com) announces that it has 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. Biophor is a pioneer in the oral fluid diagnostics industry developing immunoassays for undiluted or neat oral fluid specimens obtained with the RapidEASE Oral Fluid Collector. Oral fluid is a preferred sample type as it is easy to collect, hard to adulterate, and does not have the privacy issues associated with urine samples. Biophor will leverage the globally accelerating growth of oral fluid diagnostics (7.7% CAGR) relative to urine (4.6% CAGR) and other matrices to capture a significant portion of the $2.8B worldwide drugs of abuse testing market.