Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced that its Applied DNA Clinical Laboratories, LLC (ADCL) subsidiary is experiencing growing demand for its safeCircle™ pooled COVID-19 surveillance testing program that is being primarily driven by New York State (the “State”) schools moving to comply with the State’s Winter COVID-19 Plan (the “Plan”) that allows for pooled COVID-19 testing of their student, faculty, and staff populations based on infection rate thresholds. The Company has secured new agreements with schools and colleges that represent a potential weekly testing population of >5,000 individuals, from which a varying percentage are tested each week. Several contracts are contingent on the schools’ ability to secure funding. The Plan is also contributing to a substantial expansion in safeCircle’s sales pipeline that currently exceeds 20 schools.
The Plan targets micro-clusters to keep school infection rates under control and under their respective communities’ infection rates by requiring schools in Orange and Red micro-cluster zones to conduct weekly testing. Schools in Orange zones will be required to test 20% of in-person students, faculty, and staff over the course of a month, and schools in Red Zones will be required to test 30% of in-person students, faculty, and staff over a month1. Schools can make use of rapid tests offered by the State, though such tests either recommend that negative results be confirmed with a PCR-based test or are low throughput, thereby increasing the amount of time needed to make informed decisions to prevent outbreaks from occurring and adding further complexity to the testing process.
safeCircle is a proprietary COVID-19 pooled surveillance testing program that utilizes the Company’s PCR-based, Linea™ COVID-19 Assay Kit in conjunction with an automated, high-throughput testing workflow and equipment, software, and services to return de-identified aggregate pooled surveillance test results within 24 hours.
Dr. James A. Hayward, president and CEO, Applied DNA, said, “What we hear from schools and school districts is that they know they need to test educators and students for COVID-19, but they do not know how to access testing. Our safeCircle program is a highly customizable solution that can be easily administered to deliver ongoing, consistent, and highly accurate surveillance testing proactively to protect schools and classrooms. With safeCircle, educators can identify infections early and in a cost-efficient and expedient manner. With safeCircle, educators and students can return to the business of education.”
For Educators:
The safeCircle program for schools, pre-K through high school, is designed to minimize COVID-19 clusters in the classroom. It utilizes the Company’s high-sensitivity assay in periodic pooled testing of students, faculty, and staff using saliva or non-invasive anterior (lower) nasal swabs and can detect as little as two copies of the SARS-CoV-2 virus in the pool. Participation does not require a prescription, and aggregate results are typically returned to a school within 24 hours.
With the assay’s sensitivity, the platform is capable of detecting the virus in infected individuals, potentially before they become infectious. The program uses testing in pools of 5 individuals to avoid the potential for the dilution of an early positive sample. This compares to the pooling of up to 25 individuals by other surveillance testing providers at the cost of accuracy that could result in virus spread.
Educator Testimonials:
John Cissel, Head of School at Harbor Country Day School in St. James, NY, stated: “The safeCircle team of nurses, technicians, and scientists have made our students, their parents, and our faculty and staff very comfortable with their testing program, and our weekly surveillance testing of everyone in the building has given all of us a sense of security. Their informative approach has increased our awareness and helped us to keep the COVID virus at bay as we have had only one positive case to date.”
Robert Stark, Headmaster of the Laurel Hill School in East Setauket, NY, stated, “The safeCircle program recently identified a very early infection in our population, so early in fact, that we were able to take the appropriate steps to prevent any spread. Surveillance testing works, and our students, their families and our faculty and staff are safer because of it.”
Joshua Crane, Head of School at the Stony Brook School, NY, summarized: “We contacted Applied DNA after learning of a small cluster of students who tested positive. The safeCircle team was on campus by that afternoon, sampled our entire residential population of students and faculty into the evening, and had aggregate results to us by morning. In an era where speed and accuracy are paramount, Applied DNA delivered both, enabling us to continue school safely. I can’t say enough about their customer service and ability to make a potentially stressful process stress free.”
safeCircle – A Customized Approach
ADCL designs customized proactive surveillance programs for schools and other organizations based on their risk tolerance and budget, ranging from testing every individual once weekly to every day or other audit plan appropriate to the client’s population profile. This allows administrators to respond to risk elevations wherein a subset of the population can be serially tested at a higher frequency. Surveillance testing is done anonymously with administrators at the school or other organization tracking the identity of the encoded samples. No protected health information is transferred, no prescription is required, and aggregate de-identified results are reported only to the school or other organization. In the event of a positive pool, safeCircle scientists analyze the individual samples to confirm the presence of COVID-19 RNA. Infected member(s) of the pool are then directed by their program coordinator for the next steps, which may include consultation with their healthcare provider referral to a local certified reference laboratory partner for diagnostic confirmatory testing with an authorized RT-PCR test.
Footnotes:
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 the LineaTM 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 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.
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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 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 relating to COVID-19 surveillance 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 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.
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Contacts:
Program contact: Mike Munzer, Applied DNA Sciences, 631-240-8814, mike.munzer@adnas.com
Web: www.adnas.com, https://adnas.com/covid-19-surveillance-testing/
Twitter: @APDN
