MycoDart Inc, Carrollton, Texas, has developed a test for early and rapid detection of the emerging superbug Candida auris. Offered as a laboratory-developed test through a certified laboratory affiliate, the test provides ordering physicians with highly accurate results in hours, rather than the days required for microbiology culture testing.
According to the US Centers for Disease Control and Prevention, the yeast C. auris represents a serious global health threat.1 The pathogen was first identified in Japan in 2009, and has since spread to more than a dozen countries, including the United States. 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.1 Auris mainly affects patients who are hospitalized or in nursing homes, as outbreaks often occur in medical facilities. Environmental tests in hospitals found C. auris to be a pervasive threat, and identified its presence in emergency departments, hospital rooms, and intensive care units.
In the United States, C. auris was first presented in three cases in 2017. Since then, nearly 600 confirmed US cases have been reported, with dozens more suspected. Additionally, more than 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, MycoDart PCR, is a dual-amplification real-time polymerase chain reaction DNA test. C. auris is one of six Candida species detected by the test, which offers sensitivity and specificity above 95%, and is validated for use with blood, body fluids, and tissue specimens. The test can also be run to detect the presence of C. auris on environmental surfaces.
Dave Murcott, CEO, MycoDart.
“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,” says Dave Murcott, CEO of MycoDart. “When we saw how seriously CDC took C. auris, we put it straight into R&D, so we could add it to our Candida panel as soon as possible.”
While it will take regulatory authorization from FDA to allow MycoDart to manufacture and market test kits directly to hospitals, the company is able to offer the test immediately, when it is ordered through a single licensed laboratory. To perform ordered tests, MycoDart has teamed up with a Carrollton-based affiliate, RealTime Laboratories Inc, which is registered under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathology.
When ordered by a physician, the MycoDart PCR test can be conducted on specimens from patients suspected of having a C. auris infection. Environmental samples can be tested without a doctor’s order.
For further information, visit MycoDart.
Reference
- Candida auris: a drug-resistant germ that spreads in healthcare facilities [online]. Atlanta: Centers for Disease Control and Prevention, n.d. Available at: www.cdc.gov/fungal/diseases/candidiasis/pdf/Candida_auris_508.pdf. Accessed June 2, 2019.
