STONY BROOK, N.Y.--(BUSINESS WIRE)--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 Linea™ COVID-19 Assay Kit (the “Assay Kit”) has been selected by Stony Brook University Hospital (SBUH) for use in SBUH’s newly launched COVID-19 surveillance testing program (the “Program”). At peak operations, the Program will utilize frequent pooled testing to enable the early detection and response for potential COVID-19 cases across the 9,000-member faculty and staff of SBUH and Renaissance School of Medicine. In this surveillance testing modality, the Company expects to provide up to 1,800 (5 individuals per pooled test) of its Linea™ COVID-19 tests per week.
Applied DNA has received an initial stocking order under its Master Services Agreement (MSA) with SBUH for 3,400 tests and related consumables to enable the pooled testing of 17,000 individuals. The Company expects the receipt of recurring purchase orders for Assay Kits and consumables for the Program.
The Program is modeled after the Company’s proprietary safeCircle™ platform, a pooled surveillance testing program developed and used in-house by the Company’s Applied DNA Clinical Laboratories (ADCL) subsidiary. safeCircle utilizes the Company’s Assay Kit in conjunction with an automated, high-throughput testing workflow and equipment, software, and services to return pooled surveillance test results typically within 24 hours.
“Workplaces, classrooms, and communities are beginning to recognize pooled surveillance testing as an effective and cost-efficient means of monitoring virus activity at local, state, and national levels. Offering our high sensitivity Assay Kit for use in a surveillance testing modality creates additional sales opportunities,” stated Dr. James A. Hayward, president and CEO, Applied DNA. “We can service burgeoning demand for surveillance testing in-house at ADCL, and as we recently reported, the activity level in our sales pipeline is such that we are in the process of expanding its surveillance testing capacity. We can also empower any laboratory equipped with authorized equipment to launch their own pooled surveillance testing capacity through the implementation of the safeCircle platform.”
Concluded Dr. Hayward, “It is our privilege to work alongside SBUH on our mutual goal to mitigate COVID-19 spread in our community.”
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 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 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 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.
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 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 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, FDA and/or CMS, 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.