FDA Clears Test to Diagnose and Distinguish MRSA and MSSA

May 6, 2011

The U.S. Food and Drug Administration has cleared the first test for quickly identifying whether Staphylococcus aureus (S.aureus) infections are methicillin resistant (MRSA) or methicillin susceptible (MSSA).  The significance lies in the fact that there are many different kinds of Staphylococci bacteria.  Some can be easily treated with antibiotics, while others (MRSA) are resistant to commonly prescribed antibiotics like penicillin and amoxicillin.

The test cleared by the FDA is called the KeyPath MRSA/MSSA Blood Culture Test.  It gives healthcare providers the ability to determine if bacteria of a patient’s positive blood culture sample are MRSA or MSSA.  The determination can be made within approximately five hours after any bacterial growth is first detected.  The test does not require special instruments to obtain results.

According to Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics Device Evaluation and Safety of the FDA, the test “not only saves time in diagnosing potentially life-threatening but allows health care professionals to optimize treatment and start appropriate contact precautions to prevent the spread of the organism.”

The test is manufactured by MicroPhage, Inc. of Longmont, Colorado.

According to a FDA Press Release, the agency based the clearance on a clinical study of 1,116 blood samples after an evaluation at four major U.S. hospital centers.

To view the FDA press release, visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm254512.htm.

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