- Company Also Announces Intention to File
Near-Term EUA Request with FDA for Linea 2.0 Assay and Recently
Developed, Unsupervised, At-Home Sample Collection Kit to Expand
Addressable Market and Scope of COVID-19 Testing Services -
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 received conditional approval from the New York
State Department of Health (NYSDOH) for its Linea™ 2.0 Assay (the
“Linea 2.0 Assay”) as a Laboratory Developed Test (LDT), pending a
final review of the assay’s validation data by NYSDOH. With the
conditional approval, ADCL can immediately employ the Linea 2.0
Assay for COVID-19 testing to support New York State-based
safeCircle™ clients for the diagnostic testing of COVID-19. The
Linea 2.0 Assay is conditionally approved for individual and pooled
(up to 5-samples) testing.
Concurrently, ADCL announced its intention to submit a request
for EUA to FDA for the Linea 2.0 Assay and a recently developed
unsupervised at-home sample collection kit that, if authorized
under EUA, would allow for the service of safeCircle clients beyond
ADCL’s New York-centric operating area and to support an expansion
of safeCircle’s scope of COVID-19 testing services to include
enterprise-based, unsupervised at-home sample collection programs,
such as those anticipated under the OSHA ETS (Emergency Temporary
Standard).
The Linea 2.0 Assay is a 3-target, multiplexed, real-time
reverse transcription polymerase chain reaction (rRT-PCR) assay
targeting conserved regions of the SARS-CoV-2 Envelope (E) and
Nucleocapsid (N) genes and the human RNase P gene in respiratory
specimens. The Linea 2.0 Assay was designed as an evolution of the
Company’s Linea 1.0 COVID-19 Assay (the “Linea 1.0 Assay”), which
powered safeCircle testing prior to the onset of the Omicron
variant. The performance of the Linea 2.0 Assay exceeds the
performance of the Linea 1.0 Assay and allows ADCL to leverage its
proven laboratory workflows to provide rapid and cost-effective
testing to its safeCircle customers.
Dr. James A. Hayward, president and CEO of Applied DNA, stated,
“We are grateful to the NYSDOH for conditional approval of our
Linea 2.0 Assay with which to combat Omicron infectivity in New
York at a time when the variant is driving single-day COVID-19
cases to record levels almost daily. With our ability to support
current and prospective New York State-based clients’ testing needs
secured, we set our sights on national testing needs and
opportunities for population-scale testing that we believe can
benefit from greater access to PCR-based testing with 28–48-hour
turnaround that, paired with a digital health platform, makes
safeCircle a timely, accurate, and convenient COVID-19 testing
platform.”
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. The Company has also submitted
a request for an EUA-authorization for its LineaTM 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,
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220103005290/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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