Applied DNA Receives CLIA Certification, Enabling High Throughput Diagnostic COVID-19 Testing
Applied DNA Sciences (NASDAQ: APDN) announced that its subsidiary, Applied DNA Clinical Labs (ADCL), received CLIA certification for COVID-19 testing from the New York State Department of Health. This certification enables ADCL to conduct high-throughput diagnostic testing, enhancing its capacity to serve regional healthcare providers and boosting its safeCircle service's economics. The company aims to leverage this certification to broaden its COVID-19 testing and future diagnostic opportunities, with rapid turnaround times for results.
- ADCL received CLIA certification, enabling high-throughput COVID-19 testing.
- In-house confirmatory diagnostic testing increases revenue opportunities.
- Capacity to process thousands of samples per day offers competitive advantage.
- The EUA for the Linea COVID-19 Assay Kit is temporary and may be revoked.
- Future regulatory approvals for diagnostic candidates are uncertain.
Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that its Applied DNA Clinical Labs, LLC (ADCL) subsidiary received CLIA (Clinical Laboratory Improvement Amendments) certification from the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) for COVID-19 testing using EUA-authorized methods and devices. With this certification, ADCL can now serve as a diagnostic laboratory to conduct high throughput diagnostic COVID-19 testing utilizing EUA-authorized testing platforms, including the Company’s Linea™ COVID-19 Assay Kit. ADCL’s CLIA certification umbrella includes its Limited Service Laboratory (LSL) certification for Point-of-Care testing using COVID-19 molecular and antigen assays and community screening applications for COVID-19 and influenza.
With certification, ADCL can now pursue diagnostic COVID-19 testing for regional healthcare providers and overflow business from third-party and hospital clinical labs. Certification will also allow ADCL to capture a greater percentage of the economics of its safeCircle™ service by conducting confirmatory diagnostic testing in-house.
“CLIA certification is the cornerstone of our ADCL strategy that serves to broaden our COVID-19 testing opportunity in the near-term while catalyzing additional diagnostic opportunities in the future,” said Dr. James A. Hayward, president and CEO, Applied DNA. “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.”
About the Linea™ COVID-19 Assay Kit
The Linea™ 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 Linea™ 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 Company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of saliva and pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company’s EUA authorization for the Linea™ COVID-19 Assay Kit.
About safeCircle™
ADCL’s pooled surveillance testing program, known as safeCircle, utilizes frequent, high-sensitivity pooled testing to help prevent virus spread by quickly identifying infections within a community, school, or workplace. safeCircle provides 24-hour results using real-time PCR (RT-PCR) testing.
Click through to learn more about how safeCircle can help your community, school, and workplace: safeCircle
About Applied DNA Sciences
Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.
The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies. Applied DNA has also established a COVID-19 diagnostic and testing offering that is in the early stages of commercialization and is grounded in the Company’s deep expertise in DNA.
The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include Gov/Mil, textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.
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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.
Forward-Looking Statements
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 the assay kit could become obsolete or have its utility diminished, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA) 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) approval from U.S. FDA, changes in guidances promulgated by the CDC, U.S. FDA and/or CMS relating to COVID-19 surveillance and diagnostic testing, 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 17, 2020, and Form 10-Q filed on February 11, 2021 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.
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