– FQ1’22 test levels up over 90% from FQ4’21, signals further strengthening in FQ2’22 to date –
– The increase in test levels reflects the diversity of demand and the integration of new safeCircle™ customers; Gets contractor price for community-based pop-up testing service –
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in polymerase chain reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, announced today that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs (ADCL), saw COVID-19 testing levels increase by more than 90% (unaudited) for the quarter ended December 31, 2021, by compared to the fiscal quarter ended September 30, 2021. ADCL has also seen further strengthening in demand from the quarter ended December 31, 2021 to date. ADCL attributes the increase in demand to current safeCircle™ customers looking to safely reopen or increase operations in municipalities, campuses and businesses and to the onboarding of new customers. ADCL’s safeCircle program is a fully integrated testing platform for businesses and educational institutions that provides a full suite of COVID-19 diagnostic tests and related services, including specimen collection, design and management of testing site infrastructure, monitoring of results and management of vaccination status.
The sales outlook for safeCircle has also increased in number as companies seek to implement managed COVID-19 testing practices to mitigate impacts and other risks to business continuity and to prepare for further development of the COVID-19 pandemic and its possible scenarios.
The ADCL also announced that it had been awarded a testing subcontract to service a municipal COVID-19 testing reward. Under the testing subcontract, ADCL is testing COVID-19 samples provided by multiple community contextual collection sites.
Dr. James A. Hayward, President and CEO of Applied DNA, said, “Our approach to COVID-19 testing remains strategic by focusing on market segments where we expect testing to last. longer life. We have proven the safeCircle platform in our area of operation and are preparing to roll it out nationwide with the imminent filing of an EUA application with the FDA for our Linea™ 2.0 COVID-19 test and a associated unsupervised home sample collection kit. ”
About Applied DNA Science
Applied DNA commercializes LinearDNA™, its proprietary large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that enables large-scale production of specific DNA sequences.
The LinearDNA platform is useful in the field of nucleic acids in vitro diagnostics and preclinical market for nucleic acid drug development and manufacturing. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for the preclinical development of nucleic acid-based drugs in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (antiviral and anti-cancer), RNA therapies, regularly spaced short palindromic repeats (CRISPR), and gene therapies.
The LinearDNA platform also has non-biological applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Major end markets include textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.
Building on its deep expertise in nucleic acid-based technologies, the company has also implemented safeCircle™, a turnkey, high-throughput solution for population-scale COVID-19 testing. safeCircle is designed to search for infection within defined populations or communities using high-throughput testing methodologies that increase testing efficiency and enable rapid turnaround times.
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The Company’s common stock trades on NASDAQ under the symbol “APDN” and its publicly traded warrants trade on the OTC under the symbol “APPDW”.
Applied DNA is a member of the Russell Microcap® Index.
Statements made by Applied DNA in this press release may be “forward-looking” 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 Applied DNA’s control. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance, the possibility that Applied DNA’s test kits or testing services may become obsolete or see their utility diminished and the unknown amount of revenue and profit that will result from Applied DNA testing contracts. In addition, inherent uncertainties in research and development, future data and analysis, including whether any of Applied DNA’s or its partner’s future diagnostic candidates will progress further through the research process or receive clearance, clearance or approval from the FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health (NYSDOH), and if and when, if at all, they will receive final clearance, clearance or approval from the FDA, equivalent foreign regulatory agencies and/or NYSDOH, the unknown outcome of any request or requests to the FDA, equivalent foreign regulatory agencies and/or NYSDOH, the duration limited unknown to any FDA EUA, changes to guidelines promulgated by the CDC, FDA, CMS, and/or NYSDOH regarding COVID-19 testing, disruptions in the supply of raw materials and t supplies, ongoing SARS-CoV-2 virus mutations, changing FDA review priorities for COVID-19 EUA applications and when, if at all, any E AU application will be reviewed by the FDA, and various other factors detailed from time to time in Applied DNA’s reports and filings with the SEC, including our Annual Report on Form 10-K filed December 9, 2021, and other reports we file with the SEC, available at www.sec.gov. Applied DNA undertakes no obligation to publicly update any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unforeseen events, except as otherwise required by law.