Applied DNA and CLEARED4 Offer Fast, Cost-Effective and Turnkey Integrated Solution for Compliance with OSHA Mandate for COVID-19 Vaccination and Testing

Rhea-AI Summary

Applied DNA Sciences (NASDAQ: APDN) and CLEARED4 have launched an integrated platform to assist large employers in complying with OSHA's Emergency Temporary Standard (ETS) regarding COVID-19 vaccination and testing. This comprehensive solution offers vaccine status management and weekly pooled COVID-19 testing via Applied DNA's safeCircle platform. Employers must ensure compliance by January 4, 2022, for workforces of 100 or more. The platform is already in use by various educational institutes and businesses to streamline health verification and testing processes.

Positive

• Launch of an integrated platform to assist large employers with compliance to OSHA regulations.
• The solution combines vaccination status tracking and weekly COVID-19 testing.
• Existing utilization by educational institutions and businesses indicates market acceptance.
• Quick deployment capability in days, enhancing customer accessibility.

Negative

• Requires employers to ensure compliance by January 4, 2022, creating urgency.
• Possible delays in regulatory approval for self-collection testing kits.

- Integrated solution provides a single platform for compliance with vaccination status tracking and weekly testing requirements -

STONY BROOK, N.Y. & WATER MILL, 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 including diagnostics, and CLEARED4, one of the nation’s largest and most trusted health verification platforms, stand ready to help large employers prepare for compliance with the federally directed OSHA Emergency Temporary Standard (“ETS”) with a turnkey and cost-effective integrated offering to efficiently track employee COVID-19 vaccination status and the provision of fast and accurate weekly pooled COVID-19 testing using the Company’s RT-PCR test. Under the ETS, large employers (100+ employees) have until January 4, 2022, to ensure that their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result on at least a weekly basis before coming to work.

The Integrated Solution

By providing both vaccine status management and weekly COVID-19 testing, the integrated platform offers a single solution for compliance with the ETS. The proven platform has been utilized by numerous institutes of higher education, K-12 schools, businesses, and healthcare facilities with large populations. The integrated platform has the following essential attributes:

1. Vaccine status management via the CLEARED4 HIPAA-compliant health verification platform.
2. Rapid COVID-19 weekly pooled testing for unvaccinated employees is performed via Applied DNA Clinical Lab’s (“ADCL”) safeCircle™ platform at ADCL’s CLEP-CLIA compliant facility using noninvasive nasal swabs. Tests results are returned within 24 hours of sample receipt at ADCL. Sample collection for weekly COVID-19 pooled testing can be performed in-person (supervised) or via self-collection kits¹.
3. Weekly testing compliance, results reporting, and necessary local, state, or federal reporting is managed via the CLEARED4 platform.
4. Unvaccinated employees are alerted via text/email message to test every 7 days. Negative testing results yield a ‘green pass’ via CLEARED4 that is texted to the employee’s smartphone that authorizes access to corporate facilities. The OSHA requirements also mandate the wearing of masks by unvaccinated, tested employees. A green pass, therefore, allows employers to automate and validate which employees should be wearing a mask.
5. Vaccinated participants in the safeCircle program are given a ‘blue pass.'
6. Positive testing results yield a ‘red pass’ to the employee that should deny access to corporate facilities until said employee tests negative. The employer and the applicable Department of Health will be notified of any positive results.

Dr. James A. Hayward, president and CEO of Applied DNA, stated, “Employers are looking for an easy, customizable, and frictionless solution to help them meet all aspects of these new workplace safety and regulatory challenges. We believe the integration of safeCircle, which offers large-scale rapid PCR testing, together with the proven CLEARED4 platform that is currently utilized by a long list of marquee customers for health and vaccine status management, provides a powerful unified tool that can be quickly and easily customized to help meet the unique needs of a variety of employers to help them meet these new challenges."

"CLEARED4 and Applied DNA have been working with large employers to get ready for these anticipated mandates. By using the CLEARED4 platform, our clients are automatically compliant with the vaccine status management aspect of the new OSHA requirements being mandated. We are happy to help any organization get started. Our solution can be cost-effectively deployed in days, not months. There is still time, but the clock is running out," said Ashley John Heather, President & COO, CLEARED4.

¹ Availability of self-collection kits is subject to pending regulatory approval.

For questions about safeCircle, contact Mike Munzer of Applied DNA at 631-240-8814, mike.munzer@adnas.com

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 has also established a COVID-19 diagnostic and testing offering that is grounded in the Company’s deep expertise in DNA.

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.

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 the most trusted health validation platform for COVID-19 and infectious disease safety available today, helping organizations future-proof their operations. The platform enables its clients and users to return safely and confidently to businesses, schools and stadiums, globally. CLEARED4 captures, validates and matches user’s information to real-time health data including health surveys, temperature screening, integrated COVID-19 test results and vaccination status. All this information is then synchronized with third-party systems like door access, digital displays and other control systems. CLEARED4 also supports real-time communication via its HIPAA/FERPA-compliant platform to enterprise IT systems and partner apps. CLEARED4 automates complex health-related administrative tasks with consistent delivery of its fully interoperable and configurable platform that is quick to deploy, needing no additional software development.

CLEARED4 is helping the world reopen and stay open by issuing 10+ million safe access passes per month. CLEARED4 has been retained by organizations proactively protecting their workforce, students, visitors and fans. A partial list of CLEARED4 clients in the U.S. include corporations like Netflix, Sun Chemical, Middlesex Savings Bank, law firms, hedge funds, retail shops, venues such as Madison Square Garden, Yankee Stadium, SoFI Stadium, AT&T Stadium, and educational institutions such as CUNY, El Camino College, School of Visual Arts and Manhasset School District.

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 possibility that Applied DNA’s assay kits or testing services could become obsolete or have its utility diminished and the unknown amount of revenues and profits that will results from Applied DNA’s testing contracts. Further, the uncertainties inherent in research and development, future data and analysis, including whether any of Applied DNA’s or its partner’s future diagnostic candidates will advance further in the research process or receiving authorization, clearance or approval from the FDA or equivalent foreign regulatory agencies and whether and when, if at all, they will receive final authorization, clearance or approval from the FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any EUAs from the FDA, changes in guidance promulgated by the CDC, 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, May 13, 2021 and August 12, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211105005472/en/

For Applied DNA:

Investor Contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com

safeCircle Program Manager: Mike Munzer, 631-240-8814, mike.munzer@adnas.com

Web: www.adnas.com

Twitter: @APDN

For CLEARED4:

PR@CLEARED4.org

 

Source: Applied DNA Sciences, Inc.

FAQ

What is the integrated solution launched by Applied DNA Sciences and CLEARED4?

The integrated solution provides a platform for compliance with COVID-19 vaccination tracking and weekly testing for large employers.

What deadline do employers have to comply with OSHA's Emergency Temporary Standard?

Employers must ensure compliance by January 4, 2022.

How does the weekly pooled COVID-19 testing work in this new solution?

Weekly pooled testing is performed via Applied DNA's Clinical Lab using safeCircle, with results returned within 24 hours.

What happens if an employee tests negative or positive for COVID-19?

Negative tests yield a 'green pass' allowing access, while positive tests result in a 'red pass,' denying access until a negative result is obtained.

Which large employers are already using the CLEARED4 platform?

The platform is used by various organizations, including Netflix and multiple educational institutions.