New Early Recognition Staph Infection Test Now FDA Approved

Do you know what a S. aureus, or staph infection is? Well read on, but up front, there is a new same day test approved by the FDA this week that can determine if you have the infection and if it is potentially resistant to common treatments.

Staphylococcus is a group of bacteria that can cause a number of diseases as a result of infection of various tissues of the body. Staph-related illness can range from mild and requiring no treatment to severe and potentially fatal.

The name Staphylococcus comes from the Greek staphyle, meaning a bunch of grapes, and kokkos, meaning berry, and that is what Staph bacteria look like under the microscope, like a bunch of grapes or little round berries.

Over 30 different types of Staphylococci can infect humans, but most infections are caused by Staphylococcus aureus. Staphylococci can be found normally in the nose and on the skin (and less commonly in other locations) of 25%-30% of healthy adults. In the majority of cases, the bacteria do not cause disease. However, damage to the skin or other injury may allow the bacteria to overcome the natural protective mechanisms of the body, leading to infection.

MicroPhage, Inc., developers of quick, easy-to-use diagnostic products for bacterial identification, antibiotic susceptibility and resistance testing, announced Monday it has received clearance from the U.S. Food and Drug Administration to market its KeyPath MRSA/MSSA Blood Culture Test, which returns same-day antibiotic susceptibility results for deadly S. aureus infections.

Don Mooney, President and Chief Executive Officer at MicroPhage stated:


“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. This test is a timely and a much-needed improvement to an important area of hospital and laboratory medicine.”

As many as half of all patients with S. aureus infections are initially prescribed inappropriate or sub-optimal antibiotics before traditional test methods return information about the bacteria’s antibiotic susceptibility. The new test provides key diagnostic information 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.

The test was 98.9 percent accurate (178/180) for MRSA identification and 99.4 percent accurate (153/154) in determining MSSA within the organisms identified as S. aureus.

Richard Proctor MD, Professor Emeritus at the University of Wisconsin Medical School continues:


“The mortality rate for S. aureus bloodstream infections is in the range of 30 to 40 percent and patients are typically placed on a combination of antibiotics to fight the infection prior to obtaining the culture results. The information provided by this test will allow physicians to more rapidly optimize therapy, which is strongly correlated with better patient outcomes. Increasing rates of antibiotic resistance in most bacterial pathogens makes antibiotic selection difficult. This test provides significant advantage over existing alternatives.”

The MicroPhage product pipeline includes rapid single-pathogen and multi-pathogen diagnostic tests for simultaneous detection and determination of antibiotic susceptibility.

Drew Smith, Ph.D., Chief Science Officer at MicroPhage concludes:


“Other methods, such as PCR, mass spectrometry and immunoassays have been introduced but only provide bacterial identification and, in some cases, markers for antibiotic resistance. However, these methods are affected by genetic mutations and other biological variables that can impact their accuracy. In contrast, the MicroPhage BAT platform provides a phenotypic result that directly assesses the organism’s response to an antibiotic. The platform can be extended to a broad range of bacterial pathogens and sample types thus enabling development of a long pipeline of clinically useful susceptibility tests and test panels.”

Source: U.S. Food and Drug Administration

Written by Sy Kraft

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