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.Since January, the federal agency has been fast-tracking tests for COVID-19 under the Emergency Use Authorization. The FDA is responsible for regulating medical devices used to diagnose, prevent and treat COVID-19. 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.” 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. We’ve also enabled testing at the environmental level with our EnviroX-Rv technology. Our FDA-authorized DetectX-Rv tests at the individual level while DetectX-Cv RUO tests for identification of community spread of variants. “We’ve developed a robust platform that can test for COVID-19 across various levels. “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 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. 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. 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. Food and Drug Administration (FDA) for its patented COVID-19 multiplexed viral diagnostic assay, DetectX-Rv.
, an Arizona based biotechnology company which has developed a multiplexed microarray DNA-based pathogen testing platform, announced today that it received Emergency Use Authorization (EUA) from the U.S. SCOTTSDALE, Ariz., May XX, 2020 - PathogenDx, Inc. Receives FDA Emergency Use Authorization for Industry’s First Microarray-Based COVID-19 TestĭetectX-Rv is ideally suited for small and medium Clinical/CLIA labs to accurately detect COVID-19 easily, cost-effectively and with high throughput
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