Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the "Company"), announced that the Company’s wholly owned diagnostics testing subsidiary, Applied DNA Clinical Labs, LLC (“ADCL”), has completed all compliance and clinical data submissions required under the Clinical Laboratory Evaluation Program (CLEP) administered by the New York State Department of Health’s (DoH) Wadsworth Center to secure a clinical laboratory permit to conduct COVID-19 testing. Upon approval of certain submissions by CLEP, the Company anticipates an on-site inspection by DoH personnel in the coming weeks that, if successful, would complete the permitting process. Certification as a CLEP- approved clinical lab would initiate the launch of ADCL’s testing-as-a-service (Taas) offering that will utilize the Company’s Linea™ COVID-19 SARS-CoV-2 Assay Kit, to enable clinical testing of patient samples to help satisfy the growing testing demand in the U.S.
CLEP administers the activities of the Clinical Laboratory Reference System and provides the oversight of over 1,000 clinical laboratories and blood banks, including out-of-state facilities that accept patient samples collected in New York State. CLEP-approved laboratories located in New York State meet CLIA proficiency testing and accreditation requirements that would enable ADCL to receive patient samples collected nationally for testing.
“We are executing on an orchestrated response to the current pandemic that is grounded in what we believe to be one of the most accurate and rapid COVID-19 diagnostic PCR assays authorized by FDA EUA to build a testing business to enhance our growth,” stated Dr. James A. Hayward, president and CEO of Applied DNA. “Certain areas of the country, including in New York State, are experiencing testing shortages that will likely be exacerbated by health officials’ evolving testing strategies to more broadly and safely reopen the country and the economy. This suggests persistent and growing demand for testing that positions our TaaS offering as compelling service for customers seeking to screen consistently and on an ongoing basis.”
About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.
The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW’.
Applied DNA is a member of the Russell Microcap® Index.
About the LineaTM COVID-19 Assay Kit
The LineaTM COVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider.
The scope of the LineaTM COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
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 the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) from U.S. FDA, 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 12, 2019 and our subsequent quarterly reports on Form 10-Q filed on February 6, 2020, May 14, 2020 and August 6, 2020, 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.
Program contact: Brian Viscount, Applied DNA Sciences, 631-240-8877, firstname.lastname@example.org