S. aureus assay cleared for marketing

BD Diagnostics announced that it has received FDA clearance to market an assay for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aureus from nasal swabs.

The BD MAX StaphSR assay is the only commercially available molecular test that can identify MRSA strains with the mecC gene, which account for approximately 3% of MRSA cases, according to a company press release. Detection of these strains may reduce inappropriate surgical prophylaxis in patients who should receive vancomycin and help avoid unnecessary isolation of the patient.

"Increased accuracy in determining patient colonization with either S. aureus or MRSA can enable clinicians to implement appropriate presurgical prophylaxis and direct appropriate utilization of isolation and decolonization," said Tobi Karchmer, MD, vice president of medical affairs at BD Diagnostics. "With results available in approximately 2 hours compared to 2 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."

Surgical site infections are the most common health care-associated infections in the United States, and nasal carriage of S. aureus is a known risk factor for surgical patients. According to data in one study, the estimated treatment costs associated with surgical site infections caused by MRSA are more than $40,000 per patient, and MRSA infections increase the length of hospital stay for patients by an average of 23 days.

For more information:

Zimlichman E. JAMA Intern Med. 2013;doi:10.1001/jamainternmed.2013.9763.