– Average Daily Testing in January 2021 to Date Up 158% Over December 2020, Driven Primarily by Scale Up in Testing Contracts –
– Company Increases Production of Assay Kits (Tests) and Sample Collection Kits to Meet Further Demand –
– Applied DNA Clinical Laboratories On Track to Request Re-Inspection for CLEP-CLIA Certification –
Applied DNA Sciences, Inc. (NASDAQ:APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that its safeCircle™ pooled surveillance testing service has seen a 158% increase in the daily average number of tests performed to date in January 2021 compared to December 2020. The increase is chiefly the result of the scale-up of certain testing contracts and from the acquisition of new clients. Launched in the fourth quarter of fiscal 2020 (ended September 30, 2020), safeCircle now counts 33 primary/secondary/higher education institutions, private client, local government, and businesses as clients.
Concurrently, the Company stated that it is increasing production of its Linea™ COVID-19 Assay Kit (the “Assay Kit”) and sample collection kits to meet expected demand from existing customers, from its safeCircle service that is powered by the Assay Kit, and due to heightened interest in the Assay Kit following a recent U.S. Food & Drug Administration’s Food & Drug Administration (FDA) alert that identified the assay as an EUA-approved molecular diagnostic test that can potentially identify certain SARS-CoV-2 mutations (the “FDA Alert”). The Company also said that Applied DNA Clinical Laboratories, LLC (ADCL), its wholly-owned subsidiary, is on track to submit a request for CLEP-CLIA re-inspection during the current quarter ending March 31, 2021. If granted, CLEP-CLIA certification would enable ADCL to serve as a diagnostic laboratory that would allow for it to conduct diagnostic COVID-19 testing.
“Positive business trends for safeCircle have carried over into January and are further enhanced by the growing awareness of our platform regionally and through our partnership with CLEARED4. The profile of prospective clients is changing with more and larger opportunities in our sales pipeline,” said Dr. James A. Hayward, president and CEO.
“The FDA’s recent Alert has the potential to be a catalyst to revenue,” concluded Dr. Hayward. “We believe our assay is one of the few cost-effective and rapid ways a laboratory can detect S-gene target dropout that serves as a potential indication of a SARS-CoV-2 variant, including the U.K.’s B.1.1.7 that is characterized by increased transmissibility. We believe the ability to identify new potential COVID-19 variants with an EUA-approved molecular diagnostic test that is in-market today is essential in the continuing fight against COVID-19. Diagnostic labs using molecular diagnostic tests that do not have the ability to discriminate potential COVID-19 variants from wildtype are unable to quickly and easily identify patients that are potentially infected with a more infectious variant, which we believe may lead to further infection spread.”
safeCircle™ Pooled Surveillance Testing Service
In recent weeks safeCircle has added new clients. They include:
The U.S. division of a Germany-based international jewelry company for the testing of its New York-based staff;
A private higher education institution based on Long Island, N.Y., for the testing of its residential and student-athlete populations;
A previously announced award with a local county (N.Y.) government.
Ramp Up in Production of Kits utilized in COVID-19 Sample Collection
The Company is also increasing the production of sample collection kits utilized in surveillance testing by a factor of four to meet the testing scale-up of the Assay Kit’s largest customer and for use by new safeCircle clients.
CLEARED4 Partnership Generating New Clients
Applied DNA’s recently announced partnership with CLEARED4, a provider of return-to-work health safety solutions, has begun to bear fruit. In addition to being utilized as a mobile-friendly, value-added option for the management of aggregate results testing and reporting to a key safeCircle client, Applied DNA is now providing CLEARED4 services to a second safeCircle client, the aforementioned jewelry company. Applied DNA expects to onboard a third new client this week, the aforementioned private higher education institution. The Company believes that the combination of its safeCircle offering with the CLEARED4 platform is a compelling service in a marketplace that is in search of an accurate, easy-to-employ, faster-turnaround testing service that incents participation.
Linea™ COVID-19 Assay Kit (Test) Production
The Company’s largest customer for its Assay Kit expects to increase its use of the Assay and sample collection kits for its in-house surveillance testing program beginning in early February 2021 to coincide with its campus reopening for the Spring semester. The customer’s in-house program oversees the weekly surveillance testing of thousands of faculty and staff for the presence of COVID-19. Applied DNA receives recurring replenishment orders from the customer for both Assay and sample collection kits to meet its in-house surveillance testing needs.
In response to the FDA Alert, the Company is relaunching its sales and marketing strategy to center on the Assay Kit’s potential ability to signal for the presence of a SARS-CoV-2 variant due to S-gene target dropout. Refreshed Frequently Asked Questions are available for reference for prospective diagnostic laboratory customers nationally at https://adnas.com/sars-cov-2-69-70del-mutation-covid-assay-kit/.
Update on Applied DNA Clinical Laboratories (ADCL) CLEP-CLIA Certification
The Company is in the process of completing remediation of deficiencies in ADCL’s clinical standard of practice and expects to submit a request for re-inspection during the current quarter ending March 31, 2021. CLEP-CLIA certification will enable ADCL to capture diagnostic COVID-19 revenues currently being conducted by third party clinical labs. CLEP-CLIA certification would also potentially allow ADCL to develop an additional revenue stream through the development and commercialization of a broad-array of diagnostic tests, as laboratory-developed tests (LDTs), that once approved by the applicable regulatory authority, could be offered by ADCL.
About the Linea™ COVID-19 Assay Kit and Pooled Surveillance Testing
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.
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 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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