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 and nucleic acid-based technologies, today announced that its wholly-owned subsidiary, Applied DNA Clinical Labs, LLC, (ADCL) was awarded a competitively-bid COVID-19 testing contract by the City University of New York (CUNY) Board of Trustees to facilitate the University’s reopening in the fall (the “Contract”). The Contract term is 12 months, has a maximum value not to exceed $35.0 million, and contains no minimum weekly testing commitment.
The Contract specifies ADCL’s deployment of safeCircle™, its high-throughput, pooled COVID-19 testing program, to provide weekly asymptomatic diagnostic COVID-19 screening of on-campus unvaccinated students, staff, and faculty, and a random sampling of vaccinated individuals across the CUNY school system. ADCL’s solution includes the use of subcontractor CLEARED4’s health verification platform for appointments, sample tracking, and value-add services of campus access management. As prime contractor, ADCL will also provide on-site staffing and sample transport and logistics. CUNY projects weekly testing in the range of 20,000 to 65,000 tests over the period of the Contract. Testing levels are contingent on vaccination rates, the ratio of in-person versus remote attendance, and positivity rates within the CUNY population.
CUNY, the nation’s largest urban public university spanning 25 colleges across New York City’s five boroughs, will offer in-person and hybrid classes for the upcoming semester that will bring together a mixed population of individuals vaccinated and unvaccinated against SARS-CoV-2. For CUNY, the Contract operationalizes the CDC’s ‘Guidance for Institutions of Higher Education’ aimed at disease control and minimizing the risk of exposure in education settings.
Testing under the Contract will commence in early August 2021, and all sample collection sites will be fully operational before the start of the academic year on August 25. Testing will be conducted at ACDL’s CLEP/CLIA-certified laboratory using the Company’s Linea™ COVID-19 Assay Kit both in a pooled diagnostic screening modality and to perform reflex individual diagnostic testing of samples contained in a positive pool.
“This award reflects execution on our strategy to position safeCircle’s COVID-19 testing offerings in front of high-frequency, high-volume testing opportunities in the marketplace, including those funded by Federal and State monies released since the start of the pandemic that are earmarked to fund States’ reopening strategies. Having spent the last calendar year putting into place the constituent components for a high-throughput clinical laboratory for COVID-19 testing, this award is a significant milestone for the Company’s Diagnostics business,” stated Dr. James A. Hayward, president and CEO of Applied DNA. “Our goal is to help CUNY provide the safest environment for its diverse local and international population in what is possibly one of the largest testing cohorts in the nation.”
Concluded Dr. Hayward, “As the national educational system enters its second full year under the pandemic, the confluence of vaccine clinical successes, vaccine hesitancy, and the rise of variants sets the stage for a more complex testing environment. We believe we are uniquely positioned to address these circumstances with our high-throughput testing facility, as experts in pooled COVID-19 testing to address the needs of large groups, and with our SGS™ Mutation Panel and its ability to identify certain mutations that characterize emerging variants. To that end, we are pursuing other private sector, State and local government-level contract opportunities with the full breadth of our safeCircle offerings.”
Fiscal 2021 Third Quarter Financial Results and Investor Conference Call
The Company will report its fiscal 2021 third quarter financial results on Thursday, August 12, 2021, after market close and hold its quarterly investor conference call and webcast that same day. Additional details will be provided in a separate press release.
About safeCircle™
ADCL’s high throughput pooled 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 rapid 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 a real-time RT-PCR test intended 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 (HCP). The test is also intended for use with anterior nasal swab specimens that are self-collected in the presence of an HCP from individuals without symptoms or other reasons to suspect COVID-19 when tested at least weekly and with no more than 168 hours between serially collected specimens.
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.
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 is also the manufacturer of the EUA-authorized Linea™ COVID-19 Assay Kit.
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 (including for our COVID-19 diagnostic and other testing offerings), the unknown amount of revenues and profits that will result from the COVID-19 testing contract with the City University of New York (CUNY) Board of Trustees, the possibility that the Linea 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 guidance promulgated by the CDC, U.S. FDA and/or CMS relating to COVID-19 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 Quarterly Reports on Form 10-Q filed on February 11, 2021 and May 13, 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.
