Applied DNA Provides Clarification on Newly Authorized Asymptomatic Serial Screening Indication for LineaTM COVID-19 Assay Ki...
May 13 2021 - 9:51PM
Business Wire
Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the
“Company”), today clarifies the scope of its newly authorized
asymptomatic serial screening indication for its Linea COVID-19
Assay Kit (the “Assay Kit”) and certain information contained in
its previously disseminated 12 May 2021 press release (the “Press
Release”) relating to the U.S. Food and Drug Administration’s (FDA)
grant of a re-issued Emergency Use Authorization (EUA) that expands
the Assay Kit for asymptomatic serial screening testing.
The Company clarifies that consistent with the Assay Kit’s
prescription use only labeling, while an individual testing subject
does not need to obtain an individual prescription from their
healthcare provider for asymptomatic serial screening testing with
the Assay Kit, a blanket prescription from a healthcare provider
covering the individual being tested is necessary to comply with
all regulatory requirements relating to the Assay Kit.
Regarding asymptomatic serial screening testing with the Assay
Kit by the Company’s wholly owned clinical laboratory subsidiary
Applied DNA Clinical Laboratories, LLC (“ADCL”), if an asymptomatic
serial screening testing client cannot provide a blanket
prescription from a healthcare provider, ADCL plans to engage
healthcare providers to work with clients to obtain the necessary
blanket prescriptions. The Company believes this process will be
seamless for its testing customers while still complying with all
regulatory requirements relating to the use of the Assay 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. Applied DNA has also established a
COVID-19 diagnostic and testing offering that is in the early
stages of commercialization and is grounded in the Company’s deep
expertise in DNA.
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.
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.
The Company is offering surveillance testing in compliance with
current CDC, FDA, and CMS guidance. The use of saliva and pooled
sampling for surveillance testing, which has been internally
validated by the Company in compliance with current surveillance
testing guidance, is not included in the Company’s EUA
authorization for the Linea™ COVID-19 Assay Kit.
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 the 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 surveillance and diagnostic
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/20210513006123/en/
For Applied DNA: Investor contact: Sanjay M.
Hurry, 917-733-5573, sanjay.hurry@adnas.com Program contact:
Mike Munzer, 631-240-8814, mike.munzer@adnas.com Web:
www.adnas.com Twitter: @APDN
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