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.
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
"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
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
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.