FRIDAY, JUNE 22, 2018

FDA approves BD Diagnostics' novel StaphSR Assay

BD Diagnostics, a subsidiary of Becton, Dickinson and Company, announced on Tuesday that it has received approval from the U.S. Food and Drug Administration to market its BD MAX StaphSR Assay.

The BD MAX StaphSR Assay is part of BD Diagnostics' automated BD Max System for the rapid detection of diseases. The new assay uses BD Diagnostics' proprietary eXTended Detection Technology to rapidly and accurately detect Staphylococcus aureus and methicillin-resistant Staphylococcus aureus.

The assay works by using DNA samples taken from nasal swabs. Traditional testing methods take up to two days for results. The new BD Diagnostics Assay can detect SA or MRSA infections within two hours.

The new assay is also more accurate than existing models, which can save health care facilities up to $40,000 in treatment costs per patient that is incorrectly diagnosed with SA or MRSA infection.

"Increased accuracy in determining patient colonization with either S. aureus or MRSA can enable clinicians to implement appropriate pre-surgical prophylaxis and direct appropriate utilization of isolation and decolonization," BD Diagnostics Medical Affairs Worldwide Vice President Dr. Tobi Karchmer said. "With results available in approximately two hours compared to two or more days for culture methods, the BD MAX StaphSR Assay provides accurate and timely information to help physicians ensure safe and appropriate management of surgical patients."