- Integrated solution provides a single
platform for compliance with vaccination status tracking and weekly
testing requirements -
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:
- Vaccine status management via the CLEARED4 HIPAA-compliant
health verification platform.
- 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.
- Weekly testing compliance, results reporting, and necessary
local, state, or federal reporting is managed via the CLEARED4
platform.
- 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.
- Vaccinated participants in the safeCircle program are given a
‘blue pass.'
- 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.
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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
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