Diagnostics Company Launches New Molecular Test to Identify Deadly Superbug, Candida auris.
CARROLLTON, Texas, April 22, 2019 /PRNewswire/ -- Answering the call from the Centers for Disease Control and Prevention for laboratories to provide early and rapid detection of the emerging superbug, Candida auris, Texas-based MycoDART, Inc. has developed a test to provide doctors highly accurate results in hours, not days.
According to the CDC's fact sheet and website, C. auris (a yeast) presents a serious global health threat. It first appeared in Japan in 2009 and has spread to over a dozen countries, including the United States. C. auris mainly affects patients who are hospitalized or in nursing homes, as outbreaks often occur in medical facilities. It is highly resistant to most antifungal medications, can be easily misidentified by traditional testing methods, and is deadly, claiming more than 1 in 3 patients who contract an invasive C. auris infection.
Environmental tests in hospitals have shown that this yeast can be pervasive and has been found in hospital rooms, intensive care units, and the ER. C. auris first presented in three US cases in 2017. Since then, nearly 600 confirmed cases have been reported here, with dozens more suspected. Additionally, over 1,000 Americans have been found to be colonized with C. auris, which means they were carrying the yeast on their body and possibly spreading it, even though they weren't sick with the infection.
MycoDART's patented test, named MycoDART-PCR, is a Dual Amplification Realtime Polymerase Chain Reaction DNA test. C. auris is one of 6 species of Candida the test will detect. MycoDART-PCR offers sensitivity and specificity above 95% and is validated for blood, body fluids, and tissue. The test can also be run to detect the presence of C. auris on environmental surfaces.
"MycoDART's senior medical and clinical staff recognized several years ago that yeast and mold infections were on the rise among cancer patients, transplant patients, and other immunosuppressed individuals. When we saw how seriously the CDC took C. auris, we put it straight into R&D, so we could add it to our Candida panel as soon as possible," said Dave Murcott, CEO.
While it will take regulatory approval from the FDA to allow MycoDART to manufacture and market test kits directly to hospitals, the company is able to offer the test immediately, when ordered through a single licensed laboratory. To this end, MycoDART teamed up with its affiliate, RealTime Laboratories, Inc., a Texas based clinical laboratory, accredited by CLIA and College of American Pathology.
The test can be conducted on suspected patients but must have a doctor's order. Environmental samples can be tested with no doctor's order required.
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SOURCE MycoDART, Inc.