MycoDART, Inc., developer of proprietary DNA tests, announced its second patented assay has been granted a CPT code from the American Medical Association. MycoDART-PCR for Aspergillus joins MycoDART-PCR for Candida as one of very few diagnostic devices without FDA clearance to be recognized by the AMA.
MycoDART’s rapid diagnostic tests allow for the early detection of invasive fungal infections in immune-compromised patients, such as those undergoing transplants, as well as those with cancer and AIDS. Both tests have been clinically validated and are available for physicians to order from the company’s affiliate, RealTime Laboratories, Inc., a Texas based clinical lab accredited by CLIA and the College of American Pathology. MycoDART has also teamed up with several prestigious university hospitals to conduct dual clinical studies.
University of Augusta, UC Davis, University of Pennsylvania, Henry Ford Health, and the University of Texas at Houston are currently at work on a study to collect samples from patients with suspected exposure to Candida. The study will compare results of MycoDART-PCR with those of blood cultures, the current gold standard. The purpose of the studies is to demonstrate efficacy in the clinical environment. Baylor Health System will lead the second study, which will employ the Aspergillus assay.
Dr. Jose Vazquez is an infectious disease specialist at the University of Augusta and is the principal investigator on Candida study. According to Dr. Vazquez, “A reliable diagnostic to quickly and accurately identify these deadly infections is long overdue. Relying on blood culture, which is a hundred year old technology that is often wrong, puts the patients at further risk.”
MycoDART-PCR uses a unique process to detect very small amounts of DNA in human samples. Unlike blood cultures, which can take days to get results and are only 50% accurate, MycoDART’s accuracy is as high as 95%, and results are available within hours of receiving the specimen. Early and rapid diagnosis of invasive fungal infections is key to saving lives and driving down the cost of treatment.
Immune-compromised patients face mortality within hours of being infected if not treated appropriately. Without an accurate diagnosis, doctors must treat with costly and toxic broad-spectrum antifungals. This treatment leads to lengthier hospital stays and more complications. Targeting the right organism with the most effective drug provides the best possible outcome for the patient, the hospital and the third-party payer.