– Company’s safeCircle™ Testing Program to
Monitor for COVID-19 Among On-Campus Unvaccinated Populations –
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, today announced
that its wholly-owned subsidiary, Applied DNA Clinical Labs, LLC,
(ADCL) was awarded a testing contract by Suffolk County Community
College (the “College”) to monitor for the prevalence of COVID-19
among its unvaccinated staff and faculty in support of the
College’s reopening in the fall (the “Contract”). Testing is
scheduled to begin in the second half of September 2021. The
College, part of the State University of New York (SUNY) system, is
aligned with SUNY’s vaccination mandate, which requires all
on-campus students to be fully vaccinated against COVID-19 by
September 27, 2021.
The initial Contract term is one year and includes two one-year
options for renewal exercisable at the College’s discretion. The
Contract contains no minimum testing requirement; it stipulates a
fixed monthly fee for sample collection site services and a
separate fixed fee per individual COVID-19 test.
Suffolk County Community College is a public community college
funded in part by Suffolk County, New York. The College was founded
in 1959 and has three campuses located in Selden, Brentwood, and
Riverhead, New York. Full-time and adjunct faculty number
approximately 2,000 individuals. The College’s student population
comprises about 25,000 full- and part-time students.
Under the Contract, ADCL will deploy safeCircle™, its
high-throughput, pooled COVID-19 testing program, to provide
cost-effective COVID-19 testing. Testing will be conducted at
ACDL’s CLEP/CLIA-certified laboratory using the Company’s Linea™
COVID-19 Assay Kit both in a pooled screening modality and to
perform reflex individual diagnostic testing of samples contained
in a positive pool. ADCL will serve as prime contractor with
subcontractor CLEARED4’s health verification platform to be used
for appointments, sample tracking, reporting, program management,
and mobile access pass visibility.
“Suffolk County Community College joins new safeCircle client
The City University of New York, as well as several existing higher
education institution clients, who have turned to us for COVID-19
testing to support their 2021-2022 academic year,” stated Dr. James
A. Hayward, president and CEO of Applied DNA. “As colleges and
universities prepare to safely return to on-campus instruction
armed with a powerful tool of vaccine mandates, nevertheless the
emergence of the Delta Variant of Concern and its demonstrated
reduction on vaccine efficacy make persistent COVID-19 testing a
critical component of a comprehensive virus mitigation strategy. In
these exceptional times, safeCircle affords administrators peace of
mind with its highly accurate, affordable, and turnkey pooled
testing program that can adjust to meet evolving testing
requirements to help keep classrooms open and keeps student,
faculty, and staff populations safe.”
About safeCircle™
ADCL’s high throughput pooled 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 rapid
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
The Linea™ COVID-19 Assay Kit is a real-time RT-PCR test
intended 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 (HCP). The test is also intended for
use with anterior nasal swab specimens that are self-collected in
the presence of an HCP from individuals without symptoms or other
reasons to suspect COVID-19 when tested at least weekly and with no
more than 168 hours between serially collected specimens.
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.
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.
The LinearDNA platform also has non-biologic applications, such
as supply chain security, anti-counterfeiting and anti-theft
technology. Key end-markets include textiles, pharmaceuticals and
nutraceuticals, and cannabis, among others.
Leveraging its deep expertise in nucleic acid-based
technologies, the Company has also established safeCircle™, a
pooled COVID-19 testing program that is grounded in the Company’s
EUA-authorized Linea™ COVID-19 Assay Kit. safeCircle is designed to
look for infection within defined populations or communities
utilizing pooled testing methodologies that increase testing
efficiencies. The Company has also developed and plans to seek
EUA-authorization for its Linea™ SARS-CoV-2 Mutation Panel, an
assay-based panel for the detection of certain SARS-CoV-2 genetic
mutations.
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.
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
(including for our COVID-19 diagnostic and other testing
offerings), the unknown amount of revenues and profits that will
result from our safeCircle COVID-19 testing contracts, the
possibility that the Linea 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 guidance promulgated by the CDC, U.S. 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/20210902005149/en/
For Applied DNA: Investor contact: Sanjay M.
Hurry, 917-733-5573, sanjay.hurry@adnas.com Program Manager:
Mike Munzer, 631-240-8814, mike.munzer@adnas.com Web:
www.adnas.com Twitter: @APDN
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