FDA awards EUA to Alphadera Labs’ COVID-19 test
August 2, 2023
AlphaDERA Labs has received an emergency use authorization (EUA) for a COVID-19 test from the U.S. Food and Drug Administration (FDA).
The FDA awarded the EUA for the ALPHADx SARS-COV-2 RT-PCR Test. Under the terms of the EUA, AlphaDERA Labs can test for COVID-19 using the molecular diagnostic at its laboratory in Houston. The site is certified to perform high-complexity tests under the the Clinical Laboratory Improvement Amendments (CLIA) regulation of 1988.
AlphaDERA Labs received the EUA after evaluating its test on 60 clinical nasopharyngeal swabs specimens, half of which were positive. ALPHADx provided the same results, reporting 30 positive samples and 30 negative samples, as a “highly sensitive” FDA-authorized molecular SARS-CoV-2 test.
AlphaDERA Labs - Precision in Diagnostics, Trusted by Professionals
AlphaDERA Labs is a certified name when it comes to clinical lab testing and diagnostic services. Since our inception in 2018, we have been at the forefront of innovation, delivering accurate and reliable results and helping professionals, individuals, and communities make informed health decisions. Our commitment to excellence has positioned us as a trusted partner in the field of laboratory services.
