NEW YORK – PathogenDx said on Wednesday that its DetectX-Rv assay for COVID-19 has received CE-IVD marking.
The reverse-transcriptase PCR and DNA microarray hybridization assay uses nasopharyngeal swabs and nasal aspirate or fluid to detect targets in the SARS-CoV-2 genome within three hours of RNA extraction, the Scottsdale, Arizona-based company said in a statement. It can also be used to perform pooled sample testing for the virus and is intended for use at small and midsize laboratories that need low-cost testing, the firm said.
The test has a limit of detection of 1,000 copies per milliliter, and it obtains 100 percent specificity by analyzing the sample in triplicate for each patient swab within the array, the company added. It also analyzes "dozens of probes" in COVID-19-specific regions of the viral genome, PathogenDx said.
The test received Emergency Use Authorization from the US Food and Drug Administration in April.
PathogenDx also has a follow-on Detect-Cv Clade variant test to determine variants of concern or interest from a positive SARS-CoV-2 test result, CEO Milan Patel said in a statement. "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," he said.