- Submitted by Clinical Lab Subsidiary for its Use; Subsidiary to Manufacture the Diagnostic Kit if Approved -
Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, announced today that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC ("ADCL"), has submitted to the New York State Department of Health (NYSDOH) a validation package for its Company-developed monkeypox virus test in support of a request for full approval as a form of NYSDOH Laboratory Developed Test (LDT). The PCR-based diagnostic is designed to identify the genetic signature of the Clade II variant of the monkeypox virus that is currently prevalent in the U.S. If approved by NYSDOH, the test will be used to power ADCL's monkeypox testing services.
Named the Linea™ Monkeypox Virus 1.0 Assay, the test would be ADCL's second successful LDT in less than one year if approved by the NYSDOH. The test is part of ADCL's high-throughput infectious disease testing offering centered on high-volume testing for infectious diseases that can reoccur within a population. ADCL's Linea™ 2.0 COVID-19 Assay received conditional approval as an LDT from NYSDOH in January 2022 and currently powers ADCL's COVID-19 testing services. If approved, monkeypox testing will be performed at ADCL's CLEP/CLIA molecular diagnostics laboratory in Stony Brook, N.Y., utilizing proven workflows to ensure accurate results and competitive turnaround times.
"Our pursuit of monkeypox testing via LDT combines what we believe to be the quickest regulatory path for diagnostic approval with our proven ability to deliver short turnaround time-to-results that, as COVID-19 has taught us, can help contain virus spread," stated Dr. James A. Hayward, president and CEO of Applied DNA. "Upon NYSDOH approval, ADCL has the testing capacity to deploy to help keep New Yorkers safe. Moreover, as the test kit manufacturer, we maximize the control over our own supply chain to ensure both quality and availability."
About Applied DNA Sciences
Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid ("DNA"). Using PCR to enable both the production and detection of DNA, we operate in three primary business markets: (i) the manufacture of DNA for use in nucleic acid-based therapeutics; (ii) the detection of DNA in molecular diagnostics testing services; and (iii) the manufacture and detection of DNA for industrial supply chain security services.
The Company's common stock is listed on NASDAQ under the ticker symbol 'APDN,' and its publicly traded warrants are listed on OTC under the ticker symbol' APPDW.'
The statements made by Applied DNA in this press release may be "forward-looking" in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA's future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance, the possibility that Applied DNA's testing services could become obsolete or have their utility diminished and the unknown amount of revenues and profits that will results from Applied DNA's testing services. Further, the uncertainties inherent in research and development, future data and analysis, including whether any of Applied DNA's current or future diagnostic candidates will advance further in the research and/or validation process or receiving authorization, clearance or approval from the FDA, equivalent foreign regulatory agencies and/or the 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, disruptions in the supply of raw materials and supplies, 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, its Quarterly Report on Form 10-Qs filed on February 10, 2022, May 12, 2022, and August 11, 2022, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.