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PathogenDx Nabs CE Mark for RT-PCR Test to Detect SARS-CoV-2, Variants

NEW YORK ─ PathogenDx on Wednesday announced it has obtained CE marking for its DetectX-Cv+ test to simultaneously detect SARS-CoV-2 as well as variants of concern, variants of interest, new mutations, and emerging variants.

PathogenDx's DetectX-Cv+ couples asymmetric, endpoint RT-PCR with DNA microarray hybridization. Its fluorescence signals are measured by a plate reader and analyzed by proprietary software that can detect new variants of concern and variants of interest using an algorithm update, the firm said.

"DetectX-Cv+ can identify both COVID-19 and its variants in just a few hours, while offering accuracy equivalent to [NGS] but with the simplicity of running on standard laboratory equipment that does not require high-end bioinformatics," Milan Patel, cofounder and CEO of PathogenDx, said in a statement.

The PathogenDx test is available to routine molecular biology laboratories in Europe and, as a result, variant testing is not limited to regional or national sequencing centers, the firm said.

In a blind test coordinated by the National Institutes of Health, the test detected all variants with an assay limit in the 30 Ct range, the firm said, adding that the assay has a limit of detection of 3,000 copies/mL.

Last July, the Scottsdale, Arizona-based firm said it had obtained CE marking for its DetectX-Rv test, an RT-PCR and DNA microarray hybridization assay that uses nasopharyngeal swabs and nasal aspirate or fluid to detect targets in the SARS-CoV-2 genome within three hours of RNA extraction.

The test received Emergency Use Authorization from the US Food and Drug Administration in April.