News-2011-12-20

BD Selected Alverix as a Partner to develop and Supply Digital Reader, a Key Component of New System that Offers Users Strong Performance, Coupled With Easy-to-Read Results

San Jose, CA, December 20, 2011 – Alverix announced today that its partner BD (Becton, Dickinson and Company) has received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for the BD Veritor™ System for Rapid Detection of Flu A+B. It is the first rapid influenza test system incorporating a digital read out of results to receive CLIA waiver.

The BD Veritor System was developed by BD who partnered with Alverix for the development of the digital reader which employs Alverix’s unique and proprietary near-patient testing platform. The BD Veritor System reader utilizes Alverix’s novel optoelectronic and signal detection technologies. The BD Veritor System delivers very good positive and negative percent agreement when measured against polymerase chain reaction (PCR) results, the highest sensitivity standard currently available. Following a simple, convenient procedure, objective test results are provided on an easy to read digital display, unlike current CLIA-waived rapid influenza tests, which require a subjective visual test interpretation to determine a positive or negative test result. Alverix manufactures and supplies the BD Veritor System reader to BD.

“ We congratulate our partner BD on the achievement of these important milestones,” said Ric Tarbox, CEO of Alverix. “ In particular, we are gratified to see this important validation of Alverix’s mission to play a key role in helping to create systems that offer a combination of speed, accuracy, and convenience, and we share with BD the belief that the BD Veritor System has the potential to change the way that doctors view in-office rapid flu testing.”

Alverix is a leader in providing next-generation instrument and connectivity platforms for diagnostic Point-of-Care (POC) testing. Building upon a 30-year legacy within Hewlett Packard and Agilent, Alverix was spun off as a privately held company in 2007 and is based in San Jose, CA. Alverix’s systems enable laboratory class performance in a mobile, inexpensive format, extending testing beyond high volume sites to physician office labs, retail clinics, emerging markets and the home. Alverix’s target markets include infectious disease, drugs of abuse (DOA), cardiac markers, cholesterol/lipids, glucose and hemoglobin, among others. With strength in product design, product development and high volume manufacturing, Alverix is leading the transition of diagnostic testing from the laboratory to all locations where immediate results are critical to patient care. www.alverix.com

For more information on the BD Veritor™ System, please see: http://www.bd.com/ds/veritorsystem