PathogenDx, Inc., an Arizona based biotechnology company, announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its patented COVID-19 multiplexed viral diagnostic assay, DetectX-Rv.
DetectX-Rv is a RT-PCR and DNA microarray hybridization test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal (NP) swabs, oropharyngeal (OP) swabs, mid-turbinate swabs, anterior nasal swabs, nasal aspirates, nasopharyngeal wash/aspirates and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
DetectX-Rv offers high-throughput capability and can process controls and 94 samples in a single run.
“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.
The FDA is responsible for regulating medical devices used to diagnose, prevent and treat COVID-19. 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.
Source: Company Press Release
