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Applied DNA Sciences Garners FDA Emergency Use Authorization for SARS-CoV-2 Kit

NEW YORK – Applied DNA Sciences announced Thursday its Linea COVID-19 RT-PCR test received Emergency Use Authorization from the US Food and Drug Administration.

The company's patent-pending single-well multiplex test can now be used by CLIA-certified labs. The real-time, reverse-transcriptase PCR-based assay is designed to detect target sequences of the SARS-CoV-2 Spike gene and is approved to run on Thermo Fisher Scientific's Applied Biosystems QuantStudio Dx PCR instrument. The QuantStudio Dx can run 94 samples per hour, or more than 2,000 tests per day. The rapid test delivers results in less than one hour, the Stony Brook, New York-based firm said.

The test can be used with nasal swabs, nasopharyngeal and oropharyngeal swabs, nasopharyngeal wash, or nasal aspirates, the firm said.

"We developed the Linea COVID-19 assay kit for high-throughput operations where accurate and rapid high-volume testing is requisite," said Mohan Chellani, the company's director of diagnostic regulatory affairs. "In addition, we have worked closely with our supply chain partners to evolve safeguards to ensure a steady supply of inputs necessary for the construction of our kit.”

Last month, the firm announced it was partnering with Stony Brook University Hospital to validate the test.