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Applied DNA Sciences Subsidiary Gets CLIA Certification From NY State Department of Health

NEW YORK — Applied DNA Sciences said on Tuesday that its Applied DNA Clinical Labs subsidiary has received CLIA certification from the New York State Department of Health for SARS-CoV-2 testing.

With the certification, the lab can now perform high-throughput SARS-CoV-2 testing with assays that have received Emergency Use Authorization from the US Food and Drug Administration including Applied DNA Sciences' Linea COVID-19 RT-PCR test.

The CLIA certification, Applied DNA Sciences said, includes limited service laboratory certification for point-of-care testing using SARS-CoV-2 molecular and antigen assays and communication screening applications for SARS-CoV-2 and influenza.

The Stony Brook, New York-based company said it can now also offer SARS-CoV-2 testing for regional healthcare providers and overflow business from third-party and hospital clinical labs, as well as handle confirmatory testing for its SafeCircle pooled SARS-CoV-2 surveillance program.

"With certification in hand, we believe our capacity to process thousands of samples a day consistently, paired with the accuracy of our assay kit and its capacity for variant discrimination, and typically same-day-to-24-hour turnaround times, give us a very compelling market presence moving forward," said James Hayward, president and CEO of Applied DNA Sciences, in a statement.

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