Applied DNA Submits Request for Emergency Use Authorization to FDA for Linea™ 2.0 COVID-19 Assay and Linea™ Unsupervised At-Home Sample Collection Kit
January 21 2022 - 10:00AM
Business Wire
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, LLC (ADCL), has submitted a request to the U.S. Food and Drug
Administration (FDA) for Emergency Use Authorization (EUA) for its
Linea™ 2.0 COVID-19 Assay (the “Linea 2.0 Assay”) and Linea™
Unsupervised At-Home Sample Collection Kit (the “Linea Collection
Kit”).
If approved, the Company’s request for EUA positions ADCL to
pursue an expansion of its established safeCircle™ COVID-19 testing
platform nationally to meet the needs of enterprises seeking to
protect workforce health and avoid disruptions to operations by
mass staff absences due to Omicron’s high transmissibility and
ability to evade vaccination immunity. 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.
The Linea 2.0 Assay is a high-throughput multiplex RT-PCR assay
targeting the E and N genes of SARS-CoV-2. The Assay is variant
agnostic, can detect all known SARS-CoV-2 variants, and is
validated for single sample and robotic pooled testing. The Assay
previously received conditional approval from the New York State
Department of Health in late December 2021. The Linea Collection
Kit is designed to enable the simple self-collection of nasal swab
specimens without supervision by medical personnel. Once collected,
individual samples can be mailed directly back to ADCL or
aggregated by a testing client and bulk shipped back to ADCL.
Results are typically returned within 24-to-48 hours of a sample’s
arrival at ADCL’s clinical lab.
“The unprecedented surge in COVID-19 cases driven by the Omicron
variant, we believe, makes clear that the need for accurate and
rapid PCR-based testing is more important than ever. We believe
this EUA request positions us to service existing demand for
enterprise-scale COVID-19 testing with a compelling selling
proposition where remote work is not a scalable option and a
dependence on less sensitive, antigen-based tests can potentially
lead to outbreaks and interruptions in business continuity. Having
proved the safeCircle platform in New York State, we are pursuing
partnerships and contract opportunities to establish safeCircle
nationally,” stated Dr. James A. Hayward, president and CEO of
Applied DNA. “At the same time, while safeCircle was formed
specifically to build a COVID-19 testing platform, the potential
acquisition of a national customer base advances ADCL’s strategy to
expand its diagnostic offerings beyond SARS-CoV-2 with an installed
client base.”
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,
whether and when, if at all, the FDA will review any EUA request,
disruptions in the supply of raw materials and supplies, continued
mutations of the SARS-CoV-2 virus, 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/20220121005165/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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