BD gains EU and US approval for rapid MRSA test

16 January 2008

BD Diagnostics, a division of BD (Becton, Dickinson and Company) has gained European approval for its BD GeneOhm StaphSR assay for nasal and wound specimens and is now marketing the product in Europe.

The assay gives rapid and simultaneous identification and differentiation of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) directly from nasal and wound specimens.

BD has also won US FDA 510(k) clearance of the test for positive blood cultures. It was CE marked for positive blood cultures earlier in 2007. BD has recently submitted applications to the US FDA for clearance of the  BD GeneOhm StaphSR assay for nasal swab and wound specimens in the US.

The assay helps physicians rapidly administer the right antimicrobial treatment for patients infected with SA or MRSA. It will also allow patients colonized with SA or MRSA to be decolonised and receive appropriate prophylactic antibiotics prior to surgery. It can provide results within two hours, compared to the 24-72 hours required for traditional microbiology cultures.

"Preoperative screening for nasal carriage of Staphylococus aureus and subsequent treatment of carriers with mupirocin nasal ointment is associated with significant reduction in the postoperative Staphylococcus aureus infection rate by more than 50 percent," said Jan Kluytmans, MD, Consultant Microbiologist, Amphia Hospital Breda/Oosterhout, and Professor of Medical Microbiology and Infection Control, VUmc, Amsterdam.

"Healthcare workers around the world are diligently attempting to control transmission and infection caused by multidrug-resistant organisms, such as MRSA," said Vince Forlenza, Executive Vice President, BD. "CE marking for all three specimen claims for the BD GeneOhm StaphSR assay reflects BD's commitment to providing high-quality diagnostic tests in the battle against staphylococcal infections."

A recent study reported in the Journal of American Medical Association estimates that 94,360 patients acquire an invasive MRSA infection each year, leading to an estimated 18,650 deaths in the United States. MRSA has become the most common cause of skin and soft tissue infections (SSTIs), often presenting as a 'spider bite', but has also been associated with sepsis and necrotizing pneumonia.

Recent studies have shown a dramatic increase in patients suffering from SSTIs, with SA found to be the causative pathogen in 76% of cases. Of these SA isolates, 78% were MRSA. Although the vast majority of patients with MRSA SSTIs in the studies received empirical antimicrobial therapy, more than half of the time the prescribed agent was not active against MRSA.

BD is also developing rapid molecular tests for the detection of two other organisms that cause severe healthcare-associated infections. These tests will identify the vanA and vanB genes associated with vancomycin-resistant enterococci and the toxin gene associated with Clostridium difficile.