FDA clears MicroPhage's test for drug-resistant Staph

Longmont, CO-based MicroPhage has received 510(k) clearance from the FDA to market its KeyPath MRSA/MSSA blood culture test--BT, which returns same-day antibiotic susceptibility results for Staphylococcus aureus infections. Staphylococci bacteria can cause a number of maladies, including pneumonia, blood poisoning and certain skin infections, as HealthDay notes.

As many as half of all patients with S. aureus infections are initially prescribed inappropriate antibiotics before traditional test methods return information about the bacteria's antibiotic susceptibility, the company notes in a release. The KeyPath test provides data that enables doctors to prescribe the most appropriate antibiotics for a patient's infection up to two days sooner than is possible with current test methods.

"MRSA and other antibiotic-resistant 'superbugs' represent one of the greatest public health challenges of our century, and identifying those dangerous bacteria early is crucial in both treating patients and limiting the spread of the infection to others," said Don Mooney, president and CEO of MicroPhage. "This test is a timely and a much-needed improvement to an important area of hospital and laboratory medicine."

The KeyPath test was evaluated in a study of 1,116 blood samples at four major U.S. hospital centers. The test was 98.9 percent accurate for MRSA identification and 99.4 percent accurate in determining MSSA within the organisms identified as S. aureus.

- get the MicroPhage release
- check out the HealthDay report