- Full Service, Turnkey Solution Anchored by
Applied DNA Clinical Labs’ safeCircle™ Pooled COVID-19 Testing to
Be Deployed Across All 25 CUNY Campuses to Facilitate Fall
Re-Opening –
- Company to Report Fiscal Third Quarter
Financial Results and Hold Investor Conference Call on Thursday,
August 12, 2021 -
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 competitively-bid COVID-19 testing contract by
the City University of New York (CUNY) Board of Trustees to
facilitate the University’s reopening in the fall (the “Contract”).
The Contract term is 12 months, has a maximum value not to exceed
$35.0 million, and contains no minimum weekly testing
commitment.
The Contract specifies ADCL’s deployment of safeCircle™, its
high-throughput, pooled COVID-19 testing program, to provide weekly
asymptomatic diagnostic COVID-19 screening of on-campus
unvaccinated students, staff, and faculty, and a random sampling of
vaccinated individuals across the CUNY school system. ADCL’s
solution includes the use of subcontractor CLEARED4’s health
verification platform for appointments, sample tracking, and
value-add services of campus access management. As prime
contractor, ADCL will also provide on-site staffing and sample
transport and logistics. CUNY projects weekly testing in the range
of 20,000 to 65,000 tests over the period of the Contract. Testing
levels are contingent on vaccination rates, the ratio of in-person
versus remote attendance, and positivity rates within the CUNY
population.
CUNY, the nation’s largest urban public university spanning 25
colleges across New York City’s five boroughs, will offer in-person
and hybrid classes for the upcoming semester that will bring
together a mixed population of individuals vaccinated and
unvaccinated against SARS-CoV-2. For CUNY, the Contract
operationalizes the CDC’s ‘Guidance for Institutions of Higher
Education’ aimed at disease control and minimizing the risk of
exposure in education settings.
Testing under the Contract will commence in early August 2021,
and all sample collection sites will be fully operational before
the start of the academic year on August 25. Testing will be
conducted at ACDL’s CLEP/CLIA-certified laboratory using the
Company’s Linea™ COVID-19 Assay Kit both in a pooled diagnostic
screening modality and to perform reflex individual diagnostic
testing of samples contained in a positive pool.
“This award reflects execution on our strategy to position
safeCircle’s COVID-19 testing offerings in front of high-frequency,
high-volume testing opportunities in the marketplace, including
those funded by Federal and State monies released since the start
of the pandemic that are earmarked to fund States’ reopening
strategies. Having spent the last calendar year putting into place
the constituent components for a high-throughput clinical
laboratory for COVID-19 testing, this award is a significant
milestone for the Company’s Diagnostics business,” stated Dr. James
A. Hayward, president and CEO of Applied DNA. “Our goal is to help
CUNY provide the safest environment for its diverse local and
international population in what is possibly one of the largest
testing cohorts in the nation.”
Concluded Dr. Hayward, “As the national educational system
enters its second full year under the pandemic, the confluence of
vaccine clinical successes, vaccine hesitancy, and the rise of
variants sets the stage for a more complex testing environment. We
believe we are uniquely positioned to address these circumstances
with our high-throughput testing facility, as experts in pooled
COVID-19 testing to address the needs of large groups, and with our
SGS™ Mutation Panel and its ability to identify certain mutations
that characterize emerging variants. To that end, we are pursuing
other private sector, State and local government-level contract
opportunities with the full breadth of our safeCircle
offerings.”
Fiscal 2021 Third Quarter Financial Results and Investor
Conference Call
The Company will report its fiscal 2021 third quarter financial
results on Thursday, August 12, 2021, after market close and hold
its quarterly investor conference call and webcast that same day.
Additional details will be provided in a separate press
release.
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. Applied DNA is also the manufacturer
of the EUA-authorized Linea™ COVID-19 Assay Kit.
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.
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 the COVID-19 testing contract with the City University
of New York (CUNY) Board of Trustees, 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 and May
13, 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/20210803005888/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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