MicroGenDx Laboratories, Lubbock, Texas, has received FDA emergency use authorization (EUA) for its validated real-time reverse transcriptase polymerase chain reaction (rRT-PCR) assay for detecting the SARS-CoV-2 virus.
The test allows patients to self-collect sputum, a mucus-like mixture of saliva and other elements from the respiratory tract. Additionally, the emergency use authorization is granted for the lab’s testing with nasopharyngeal swabs, of which the lab has performed more than 16,000 tests. However, due to supply shortages for swabs and personal protective equipment and in light of mounting scientific validation, the lab sees greater potential for increased sputum and saliva testing. MicroGenDx is currently performing the requested paired-sample analysis for its saliva-only test and anticipates FDA support on it in the near future.
As a high-complexity lab developing and processing its own validated laboratory-developed test, and not a test kit, all of MicroGenDx’s covid-19 tests are validated under its Clinical Laboratory Improvement Amendments certification. However, MicroGenDx sought EUA from FDA to further clarify the validity of the test for hospitals, clinicians, and patients.
“We continue to work tirelessly to make a significant impact on the testing crisis. The hurdles to covid-19 testing have been daunting. We speak daily with governors, business owners, and hospitals administrators looking for better options,” says Rick Martin, chief executive officer of MicroGenDx. “The additional support of FDA through its EUA opens the door for us to meet the demand and utilize our full testing capacity. We have bolstered our existing diagnostic teams to scale testing in accordance with the growing influx of tests we’ve started performing since last month.”
For more information, visit MicroGenDx Laboratories.