Cepheid Tackles a Major Hospital Expense
Using genetics to contain costly drug-resistant diseases.
Cepheid (CPHD) announced on Wednesday that it received clearance from the FDA to market Xpert VanA, a test developed to detect the vanA gene in patients. The test allows doctors to determine which patients will be resistant to treatment with the high-strength antibiotic vancomycin.
Since the saturation of antibiotics into the population began in the 1960s, more and more types of infections are becoming resistant to treatment with antibiotics. Methicillin-resistant Staphylococcus aureus (MRSA) infections have become one of the most prevalent hospital-acquired infections, also known as health care-associated infections (HAI), in the last two decades. MRSA infections don't respond to most antibiotics and may only be sensitive to vancomycin, usually the antibiotic of last resort.
Vancomycin-Resistant Enterococcus (VRE), another form of bacteria that's resistant to all forms of treatment, has become one of the most serious issues in hospitals because it attacks people with weak immune systems -- patients in the burn ICU, the neonatal ICU, and the pediatric ICU being the most susceptible, according to the Centers for Disease Control and Prevention.
The test by Cepheid produces results in less than an hour and allows doctors and hospitals to take extra precautions when dealing with patients who won't respond to treatment with vancomycin; giving these patients a higher chance for a successful recovery.
"Many patients in the areas of oncology, hematology, nephrology, transplant, and abdominal surgery units are at highest risk for contracting VRE. Therefore, it's imperative to prevent potential outbreaks by testing for vanA upon admission of high-risk patients," said Cepheid's Chief Medical and Technology Officer Dr. David Persing. "Several recent studies have demonstrated that a policy of recognition, prevention, and control of vancomycin-resistant organisms that colonize patients in health-care settings can lead to a reduction in transmission rates. A rapid test mitigates perceived drawbacks to preemptive isolation and maximizes medical value by delivering actionable results almost immediately."
According to the CDC, data collected in 2006 and 2007 showed that one in eight hospital-acquired infections was caused by the enterococcus bacteria, with 30% of those being vancomycin-resistant. The report, done in March 2008 by the CDC, showed that health care-associated infections cost US hospitals between $28.4 billion and $33.8 billion annually.
This is the ninth test by Cepheid to be cleared by the FDA. The genetic test-making company, which has a market cap of $804 million, jumped on the Xpert VanA test news, gaining more than 5% to trade above $13.80 by midday Wednesday. The stock has traded between $4.93 and $15.98 over the last 52 weeks.
Earlier this week, Cepheid also got emergency use authorization from the FDA for its Xpert Flu A Panel test that detects the 2009 H1N1 influenza virus in less than one hour.
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