Applied DNA Sciences’ clinical laboratory subsidiary, Applied DNA Clinical Labs, has submitted a request seeking Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for two products.
These products are the Linea 2.0 COVID-19 Assay and Linea Unsupervised At-Home Sample Collection Kit.
The Linea 2.0 Assay is a multiplex RT-PCR assay designed to target the E and N genes of SARS-CoV-2. It can detect all known SARS-CoV-2 variants.
The company stated that the assay is validated for single-sample and robotic-pooled testing.
