LOS ANGELES--(BUSINESS WIRE)--MiraDx, a Los Angeles-based molecular genetics company that transitioned its CLIA-certified lab to provide COVID-19 tests for essential workers, is now expanding access to its PCR viral testing to public and private universities and colleges across the country. MiraDx aims to enable students, faculty, and staff to resume on-campus education later this year in an environment that provides a clear framework and easy and comprehensive access to highly accurate testing for the COVID-19 virus.
MiraDx is able to develop testing programs customized to the needs of an individual institution. Notably, the MiraDx lab, which is now exclusively processing COVID-19 tests, has dedicated reserved capacity for college programs, both to optimize turnaround time and mitigate the backlog many other labs are currently experiencing. With specific days allocated to individual schools, MiraDx will be able to deliver test results back to school officials through a secure server within 48 hours of receipt at the lab.
“Accurate and sensitiveCOVID-19 testing of all Americans is of the utmost importance,” said Dr. Joanne Weidhaas, co-founder of MiraDx. “As our company continues to provide testing for thousands of first responders and essential workers, we have also turned our attention to another matter of national importance: enabling our youth to continue their on-campus education as safely and as soon as possible. Our goal is to contribute in a meaningful way to institutions of higher learning to allow students, faculty, and staff to return to campus in good health and give parents peace of mind that their children are safe.”
MiraDx’s discussions with over 100 schools across the country, along with guidance from health officials, have helped to inform the development of emerging testing protocols, to include day one clearance testing of the entire student body and faculty, followed by repeat “sentinel” testing throughout the semester.
“We are focused on delivering the highest quality, most sensitive and dependable testing programs possible,” said Dr. Weidhaas, herself an educator at UCLA. “We are only going to commit to programs today we know we can achieve in the fall — we are not going to sell capacity we do not have, and in fact, we are building in a buffer of capacity in each college testing day.”
MiraDx has a CLIA-certified lab with a “high complexity molecular processing” designation that allows it to conduct PCR testing, a highly sensitive approach that results in over 90 percent accuracy in COVID-19 testing and is considered the gold standard in testing. To determine whether an individual is infected with COVID-19, a sample is collected from a swab of the back of the throat, where the highest viral load exists for this coronavirus. The MiraDx test includes an air-tight vial, collection swab, a biohazard bag, and simple instructions for collecting the sample, which is collected under the supervision of a healthcare professional. MiraDx’s analysis technique can identify as little as four copies of COVID-19 RNA in an individual sample, meaning that the virus can be detected even during the early stages of infection and/or in asymptomatic individuals. Non-PCR based testing approaches are either less sensitive (resulting in more false negatives) or 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 treatment, 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. To learn more about MiraDx, please visit miradx.com. Please send inquiries to firstname.lastname@example.org