27 May 2020 - - Los Angeles-based molecular genetics company MiraDx has transitioned its CLIA-certified laboratory to provide COVID-19 PCR testing, is further expanding access to skilled nursing facilities in California, the company said.

This will help these facilities provide fast and accurate COVID-19 testing for health care personnel and residents in accordance with recently released guidelines issued by the California Department of Public Health.

The MiraDx lab, which is now exclusively processing COVID-19 tests, has capacity of up to 5,000 tests per day for SNFs to ensure they are able to comply with the state's guidelines, which include: exclusive use of PCR testing with 48-hour turnaround time; baseline testing for all residents and healthcare personnel in facilities that do not currently have a positive case; and testing of 25 % of healthcare personnel every seven days, including staff from multiple shifts and facility locations, with 100 % of each facility's staff being tested each month.

MiraDx's analysis technique can identify as little as four copies of coronavirus RNA in an individual sample, meaning that the virus can be detected at even the early stages of infection and/or in asymptomatic individuals.

Other types of tests currently on the market are either less sensitive (resulting in false negatives) or they do not tell patients when they are no longer contagious, which either leaves them in quarantine too long or presents the risk of them coming out of quarantine too soon.

MiraDx's COVID-19 test has been developed in line with the FDA's Emergency Use Authorization requirements.

Dr. Joanne Weidhaas, MD, PhD, MSM is the co-founder of MiraDx and a professor and vice-chair in the department of radiation oncology at UCLA.

MiraDx is a Los Angeles-based molecular genetics company that identifies, validates, develops, and delivers novel germline biomarker tests for individualized cancer treatments, and now performs COVID-19 testing.

Its goal is to improve human health and advance personalized medicine through the application of novel functional germline biomarkers.