Microarray-Based COVID-19 Test Analyzes Sample in Triplicate for Each Patient Swab Within Each Array For 100% Specificity

PathogenDx, Inc. (Scottsdale, AZ, USA) has received the CE-IVD Mark for the sale and distribution of its patented DetectX-Rv Microarray Assay for COVID-19 testing across Europe. PathogenDx's DetectX-Rv microarray utilizes nasopharyngeal swabs and nasal aspirate or fluid to detect SARS-CoV2 within three hours after RNA extraction, and has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Its multiplex system also has the capability of pooled sample testing for the detection of SARS-CoV2 in multiple samples at one time, dramatically increasing COVID-19 testing throughput.

DetectX-Rv delivers superior accuracy based on its proprietary technology of analyzing dozens of probes in COVID-19 regions of the viral genome, delivering a Limit of Detection of 1,000 copies/mL. The test also ensures 100% specificity by analyzing the sample in triplicate for each patient swab within each array, not just once as conducted in currently approved COVID-19 tests.

"Receiving the CE-IVD Mark for our DetectX-Rv test is a massive milestone for our company and will not only help detect COVID-19 in Europe as the pandemic sweeps on, but with the company's follow-on Detect-Cv Clade variant test helps identify the Variant of Concern and/or Variant of Interest from any positive result processed either from DetectX-Rv or any other molecular platform," said Milan Patel, Co-founder and CEO of PathogenDx. "Although we are in the second year of the pandemic and vaccine distribution has greatly improved, COVID-19 and its variants persist in our global community. The virus will continue to mutate and we need to be able to identify if an infected patient has a particular variant in order to provide the most effective clinical and therapeutic treatment. Global distribution of diagnostic tests like our DetectX-Rv test is crucial in helping limit the spread of COVID-19 and its variants."

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PathogenDx, Inc.