131 0 Kommentare Applied DNA Provides Update on Status of New York State Laboratory Permit for Clinical Labs Subsidiary

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.