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MicroGenDX Receives FDA Emergency Use Authorization for COVID-19 Test to Expand Testing Capacity

Laboratory ramps up to full capacity of more than 10,000 tests per day with a 24-hour turnaround time

by MicroGenDX Laboratories
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ORLANDO, FL — April 26, 2020 — MicroGenDX Laboratories, the world leader in providing PCR and next generation DNA sequencing in microbial identification, has received FDA Emergency Use Authorization for its validated real-time reverse transcriptase PCR (rRT-PCR) assay for detecting the SARS- CoV-2 virus.

Increasing evidence supports the use of sputum and saliva for rapid and accurate detection of  SARS-CoV-2. Since late March 2020, MicroGenDX has collected and tested the largest sampling of saliva and sputum (more than 14,000 tests) and ongoing analysis continues to find these samples to be high-quality and more sensitive than nasal samples. A recent study out of Yale also found saliva to be more sensitive for SARS-CoV-2 detection in patients than nasopharyngeal swabs. 

The test allows patients to self-collect sputum, a mucus-like mixture of saliva and other elements that come from the respiratory tract. Additionally, the EUA is granted for the lab’s testing with NP swabs, of which the lab has performed more than 16,000 tests. However, due to supply shortages for swabs and PPE (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. 

MicroGenDX is listed on the FDA Website as a resource laboratory for COVID-19 Testing as “Southwest Regional PCR dba MicroGenDX Laboratory.” 

MicroGenDX was one of the first national laboratories to validate and compare the testing of a variety of sample sources: sputum, saliva and nasopharyngeal (nasal). As a high-complexity lab developing and processing its own validated laboratory developed test (LDT), and not a test kit, all of the lab’s COVID-19 tests are validated under its Clinical Laboratory Improvement Amendments (CLIA) license. However, MicroGenDX sought EUA from the 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. The additional support of the 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,” said Rick Martin, CEO of MicroGenDX. 

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Additional Test Information

The benefits for increased saliva and sputum testing are immense. These tests do not require swabs and other supplies that are experiencing a shortage. A provider does not have to perform the sample collection, thus decreasing patient-to-provider transmission of the virus. The patient does not suffer an uncomfortable collection experience. 

In addition to a simplified collection process, MicroGenDX’s testing turnaround is 24 hours, eliminating the chances that the RNA will break down waiting for processing, which has led to false negatives for tests at other laboratories. 

MicroGenDX runs its COVID-19 Rapid PCR Test at its diagnostic laboratory in Lubbock Texas, and accepts samples from every state.

MicroGenDX Laboratories

MicroGenDX Laboratories