NEW YORK — Applied DNA Sciences said on Tuesday that it has received conditional approval from the New York State Department of Health for its Linea 2.0 COVID-19 assay as a laboratory-developed test.
Although a final review of the assay's validation data by the NYSDOH is pending, the conditional approval — which covers testing in individuals, as well as pooled testing with up to five samples — allows Applied DNA to roll out the RT-PCR-based test to support clients of New York state's SafeCircle program for the diagnostic testing of COVID-19, the company said.
Stony Brook, New York-based Applied DNA said it also intends to submit the Linea 2.0 assay, along with an unsupervised, at-home sample collection kit, for Emergency Use Authorization from the US Food and Drug Administration.
The Linea 2.0 test is designed to detect conserved regions of the SARS-CoV-2 E and N genes in respiratory samples. It is a next-generation version of the company's Linea assay, which detects the SARS-CoV-2 S gene and received EUA from the FDA in mid-2020.
Last year, Applied DNA's Applied DNA Clinical Labs subsidiary received CLIA certification from the NYSDOH, allowing it to perform high-throughput SARS-CoV-2 testing.