FDA Okays Cepheid’s Test for MSRA
PDF FDA signed off yesterday on a new test for identifying Methicillin-resistant Staphylococcus aureus (MSRA), the leading cause of hospital-acquired infections. The Xpert MSRA test, made by Sunnyvale, CA-based Cepheid, runs on the company’s GeneXpert System and delivers results in just over one hour.
According to the CDC, more than 2 million infections occur in hospitals annually, and more than 100,000 hospital patients die each year as a result of contracting an infection while being treated for another condition. The Veterans Health Administration is taking a lead role in improving policies to reduce MRSA infection. In January 2007, it issued a directive requiring all VHA facilities to implement MRSA surveillance programs. Cepheid is currently working with VA hospitals to potentially deploy Xpert MRSA in compliance with this mandate.
MRSA is a bacterium that is resistant to antibiotics including methicillin, oxacillin, penicillin and amoxicillin; it affects those with weakened immune systems, such as hospital patients and nursing home residents. When MRSA enters the body through the skin, it can cause serious skin infections, and if it enters the bloodstream or lungs, it can cause critical blood infections, pneumonia and death.
One Response to “FDA Okays Cepheid’s Test for MSRA”
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[...] gained FDA approval for its MRSA blood, skin and soft tissue diagnostics back in April. This week, the company announced that they’ll be launching GeneXpert in Europe as well. The [...]
I am glad to hear the above. My father just died from MSRA2 that he obviously got while in Rehab. He lived in Europe. What saddens me the most is that we saw a pimple like sore on his leg at midnight 4/15/08 which had grown to a size of a baseball by 3am and busted open by 6am to where we called the ambulance and he had emergency surgery on having the wound cleaned. It was noted it was MSRA2 infection. He died on April 20, 08. I keep wondering, had we known what it looked like, had we called the ambulance at 12 or 3 at first sight, would it have made a difference. And, why was he released to home from Rehab, with this infection? Would this test have saved his life?
[...] of Cepheid’s Xpert MRSA test (FDA approved in April 2007) increased 35% from the first quarter, reaching approximately $11 million – a figure I find [...]