Applied DNA Clinical Labs has received conditional approval from the New York State Department of Health for use of its Linea 2.0 assay as a laboratory-developed test to detect COVID-19 infection.
With the conditional approval, Applied DNA Clinical Labs, a clinical laboratory subsidiary of Applied DNA Sciences, can immediately employ the Linea 2.0 assay to support New York-based safeCircle clients for the diagnostic testing of COVID-19. The assay is conditionally approved for individual and pooled testing.
Concurrently, the firm announced it plans to submit an emergency use authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the Linea 2.0 assay and a recently developed at-home sample collection kit. If the FDA authorizes the EUA, the at-home test could be used for safeCircle clients outside of New York.
