- FQ1’22 Testing Levels Up Over 90% Compared to
FQ4’21, Reports Further Strengthening in FQ2’22 to Date -
- Increase In Testing Levels Reflects Diversity
in Demand and the On-boarding of New safeCircle™ Clients; Secures
Subcontractor Award for Community-based Pop-Up Testing Service
-
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a
leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing
and nucleic acid-based technologies, announced today that its
wholly-owned clinical laboratory subsidiary, Applied DNA Clinical
Labs (ADCL), has seen COVID-19 testing levels increase greater than
90% (unaudited) for the quarter ended December 31, 2021, compared
to the fiscal quarter ended September 30, 2021. ADCL has also seen
a further strengthening of demand since the quarter ended December
31, 2021, to date. ADCL attributes the increase in demand to
current safeCircle™ clients seeking to safely reopen or increase
activities at municipalities, campuses, and businesses and the
on-boarding of new clients. ADCL’s safeCircle program is a fully
integrated testing platform for enterprise and educational
institutions that provides a full range of COVID-19 diagnostic
testing and associated services, including sample collection, test
site infrastructure design and management, results tracking, and
vaccination status management.
safeCircle’s sales prospects have also increased in number as
enterprises seek to put into place managed COVID-19 testing
practices to mitigate impacts and other risks to business
continuity and to prepare themselves for further development of the
COVID-19 pandemic and its possible scenarios.
ADCL also announced that it secured a testing subcontract to
service a municipal COVID-19 testing award. Under the testing
subcontract, ADCL is testing COVID-19 samples provided by multiple
community-based pop-up collection sites.
Dr. James A. Hayward, president and CEO of Applied DNA, stated,
“Our approach to COVID-19 testing remains strategic whereby we are
focused on market segments in which we expect testing to be
longer-lived. We have proved the safeCircle platform in our
operating area and are moving to deploy it nationally with the
imminent filing of a request for EUA to the FDA for our Linea™ 2.0
COVID-19 Assay and an associated unsupervised, at-home sample
collection kit.”
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
high-throughput turnkey solution for population-scale COVID-19
testing. safeCircle is designed to look for infection within
defined populations or communities utilizing high throughput
testing methodologies that increase testing efficiencies and
provide for rapid turn-around-times.
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,
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,
equivalent foreign regulatory agencies and/or the New York State
Department of Health (NYSDOH), and whether and when, if at all,
they will receive final authorization, clearance or approval from
the FDA, equivalent foreign regulatory agencies and/or NYSDOH, the
unknown outcome of any applications or requests to FDA, equivalent
foreign regulatory agencies and/or the NYSDOH, the unknown limited
duration of any EUAs from the FDA, changes in guidance promulgated
by the CDC, FDA, CMS an/or NYSDOH relating to COVID-19 testing,
disruptions in the supply of raw materials and supplies, continued
mutations of the SARS-CoV-2 virus, shifting review priorities of
FDA for COVID-19 EUA requests and when, if at all, any EUA request
will be reviewed by FDA, 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 9, 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/20220118005756/en/
Investor Relations 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
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