Applied DNA Partners with CLEARED4 on Pooled COVID-19 Surveillance Testing Program

·7 min read

– Applied DNA’s safeCircle™ Program Integrates with CLEARED4 Digital Platform for Online Health Safety Management and Reporting, Option Geared for Scaling of High-Volume Testing Clients –

Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced today that its wholly-owned subsidiary, Applied DNA Clinical Laboratories, LLC (ADCL) has entered into a reseller and sales referral partnership with CLEARED4, a field-proven, New York-based provider of return-to-work health safety solutions. Under the terms of the partnership, ADCL can resell subscriptions to CLEARED4’s platform as part of ADCL’s safeCircle™ pooled COVID-19 surveillance testing program, and CLEARED4 can refer its clients seeking pooled COVID-19 surveillance testing to ADCL.

The companies have integrated ADCL’s safeCircle laboratory testing operations with CLEARED4’s return-to-work health safety platform as a value-added option for current and prospective ADCL clients. CLEARED4 has also integrated ADCL’s cost-effective pooled surveillance testing solution into its HIPAA-compliant platform and can offer safeCircle to its existing and prospective clients to enhance their COVID-19 safety protocols. The CLEARED4 platform recently issued its one-millionth return-to-work Access Pass to its national client base that is attracted by the platform’s highly customizable user experience: mobile text and email messaging; a suite of health-centric modules for surveys and contact tracing and reporting; on-site kiosks; and now integrated with safeCircle’s PCR-based pooled surveillance testing and reporting to manage valuable COVID-19 clearance and to help empower safe re-openings. ADCL can now offer clients new platform management features following safeCircle’s integration with CLEARED4, including the ability to automate the management and monitoring of clients’ surveillance testing programs and ensure timely communication of valuable testing program results and quarantine compliance.

ADCL’s newest safeCircle client, the Suffolk County (N.Y.) Government, is utilizing CLEARED4 to manage the reporting of COVID-19 pooled surveillance testing for portions of its workforce. Applied DNA also recently purchased an end-user license to deploy the CLEARED4 platform for its own internal pooled surveillance testing program for its employees.

Dr. James A. Hayward, president and CEO, Applied DNA, said, "Partnering with CLEARED4 aligns with our growth expectations for the safeCircle platform and is especially functional for scaling high-volume clients. Identifying potential infections early and in a cost-efficient and rapid manner is how pooled surveillance testing gets workers back to work, students back to school, and communities to reopen. With business momentum increasing, we look to grow and service our safeCircle client base with partners who offer value-added features."

Dr. Soumi Eachempati, CEO of Chelsea Health Solutions and Cleared4, and former Professor of Surgery and Public Health at Weill Cornell Medical School, stated, "The partnership between Applied DNA and CLEARED4 offers an unmatched level of COVID-19 risk mitigation and management to schools and businesses. CLEARED4’s medically-based software platform has already yielded over one million access passes. We are poised to create millions more through this partnership and expansion into entertainment and sporting venues, as well as dining and travel uses, with our novel vaccine verification technique."

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 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.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

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.

About CLEARED4

CLEARED4 is one of a suite of health-safety solutions from Chelsea Health Solutions, a NY company, enabling businesses, schools, stadiums and municipalities across America to return safely during this pandemic. CLEARED4 is a patent-pending, HIPAA compliant platform that provides a higher level of safety, compliance and automation where communicable health issues could occur and afflict other individuals. Pioneered from advanced technology, CLEARED4 includes advanced symptom monitoring, integrated access control, automated contract tracing, Covid-19 testing and vaccination verification.

Chelsea Health Solutions launched the CLEARED4 platform in April 2020 with CLEARED4WORK, and more recently launched additional vertical specific health-safety solutions including CLEARED4CLASS, CLEARED4FANS, CLEARED4DINING and CLEARED4TRAVEL.

CLEARED4 is easy to implement and can be integrated into the reopening plan of a new client within 24 hours. For more information, visit www.Cleared4.org.

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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201229005075/en/

Contacts

Investor contact: Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, sanjay.hurry@adnas.com
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

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