Applied DNA Receives New York State Department of Health Conditional Approval for Linea™ 2.0 COVID-19 Assay as Laboratory Developed Test

Key Facts

• STONY BROOK, N.Y.--()--Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, announced today that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs (ADCL), has received conditional approval from the New York State Department of Health (NYSDOH) for its Linea™ 2.0 Assay (the “Linea 2.0 Assay”) as a Laboratory Developed Test (LDT), pending a final review of the assay’s validation data by NYSDOH.
• Concurrently, ADCL announced its intention to submit a request for EUA to FDA for the Linea 2.0 Assay and a recently developed unsupervised at-home sample collection kit that, if authorized under EUA, would allow for the service of safeCircle clients beyond ADCL’s New York-centric operating area and to support an expansion of safeCircle’s scope of COVID-19 testing services to include enterprise-based, unsupervised at-home sample collection programs, such as those anticipated under the OSHA ETS (Emergency Temporary Standard).
• Dr. James A. Hayward, president and CEO of Applied DNA, stated, “We are grateful to the NYSDOH for conditional approval of our Linea 2.0 Assay with which to combat Omicron infectivity in New York at a time when the variant is driving single-day COVID-19 cases to record levels almost daily.
• Further, the uncertainties inherent in research and development, future data and analysis, including whether any of Applied DNA’s or its partner’s future diagnostic candidates will advance further in the research process or receiving authorization, clearance or approval from the FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health (NYSDOH), and whether and when, if at all, they will receive final authorization, clearance or approval from the FDA, equivalent foreign regulatory agencies and/or NYSDOH, the unknown outcome of any applications or requests to FDA, equivalent foreign regulatory agencies and/or the NYSDOH, the unknown limited duration of any EUAs from the FDA, changes in guidance promulgated by the CDC, FDA, CMS an/or NYSDOH relating to COVID-19 testing, disruptions in the supply of raw materials and supplies, continued mutations of the SARS-CoV-2 virus, shifting review priorities of FDA for COVID-19 EUA requests and when, if at all, any EUA request will be reviewed by FDA, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 9, 2021, and other reports we file with the SEC, which are available at www.sec.gov.

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