SCOTTSDALE, AZ — May 2021 — PathogenDx, Inc., an Arizona based biotechnology company which has developed a multiplexed microarray DNA-based pathogen testing platform, announced that it received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its patented COVID-19 multiplexed viral diagnostic assay, DetectX-Rv.
PathogenDx’s DetectX-Rv microarray utilizes nasopharyngeal swabs and nasal aspirate or fluid to detect SARS-CoV2, with a RNA isolation step that saves on consumables, time and labor. DetectX-Rv analyzes the N1 and N2 target areas of the SARS-CoV-2 viral genome in triplicate per sample, ensuring no dropouts associated with variants.
The test uses off-the shelf standard lab equipment and the application of a specialized 96-well plate developed to meet the varying daily test volumes that small and medium CLIA labs experience, without incurring economic loss on unused wells.
“The entire PathogenDx team is committed to applying our deep knowledge of clinical diagnostics technology to develop accurate tests that can help contain the COVID-19 pandemic,” said Milan Patel, co-founder and CEO of PathogenDx. “We’ve developed a robust platform that can test for COVID-19 across various levels. Our FDA-authorized DetectX-Rv tests at the individual level while DetectX-Cv RUO tests for identification of community spread of variants. We’ve also enabled testing at the environmental level with our EnviroX-Rv technology. We believe that by offering this holistic capability, we will have the tools to rapidly isolate, treat and secure the health and safety of the public and the environment we live, work and socialize in. This suite of tests is critically needed to safely send children back to school as well as bring some level of normalcy back into our communities and workplace.”
The FDA is responsible for regulating medical devices used to diagnose, prevent, and treat COVID-19. Since January, the federal agency has been fast-tracking tests for COVID-19 under the Emergency Use Authorization.
- This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
- This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
- The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.