- Assay Kit Now Available for Use Without a
Prescription -
- Approved for Immediate Use by CLIA-certified
Laboratories -
- Positions Assay Kit to Support Reopening
(Return-to-School/Return-to-Work) Strategies -
- Increases Testing Throughput via Addition of
New Robotic Extraction Platform -
- Immediate Deployment in Applied DNA’s
CLIA-certified Clinical Lab -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the
“Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing, today announced that the U.S. Food and Drug
Administration (FDA) has granted the Company’s Linea™ COVID-19
Assay Kit (the “Assay Kit”) a re-issued Emergency Use Authorization
(EUA) that expands the Assay Kit’s intended use to include serial
screening of asymptomatic individuals. The expanded intended use
allows for the serial testing of individuals with or without
symptoms, eliminates the prescription requirement, and returns
results to individuals. With the recent receipt of CLIA
certification by its Applied DNA Clinical Labs, LLC (ADCL)
subsidiary, the expanded intended use enables the Company to now
offer recurring testing strategies with individual result reporting
without a prescription to support the safer reopening of schools,
workplaces, nursing homes and skilled nursing facilities, and other
places where people gather regularly in numbers. The Assay Kit with
its expanded intended use is also available for immediate purchase
by CLIA-certified laboratories nationally.
“The expanded intended use for our Assay Kit supports our
systematic approach to expanding the addressable market for our
COVID-19 testing services and Assay Kit that is aligned with
COVID-19 ‘normalization’ strategies and funding sources aimed at
reopening the economy,” said Dr. James A. Hayward, president and
CEO, Applied DNA. “The ability to return results to the individual
and the elimination of the prescription requirement, we believe,
substantially differentiates ADCL’s services in the testing market
and elevates the value of our Assay Kit to clinical laboratories
that can now bring to bear our high sensitivity PCR-based test –
still the gold standard for COVID-19 diagnostics – to help prevent
people with asymptomatic infections from turning into unsuspecting
super-spreaders. We are further characterized by the ability of our
Assay Kit to discriminate some variants. We believe that a rigorous
serial testing program is the most effective way to confirm current
COVID-19 status as part of any reopening strategy.
“As access to vaccines expands and certain COVID-19-related
restrictions are eased, the confluence of vaccinated,
under-vaccinated, vaccine ineligible, or otherwise
immune-compromised populations, particularly in such mixed settings
as skilled nursing facilities where staff and patients interact,
makes asymptomatic serial testing more relevant to at-risk
populations. Asymptomatic serial testing, together with a greater
testing throughput afforded to us and those CLIA-certified
laboratories that purchase our Assay kits that now are authorized
for additional robotic automation, makes our Assay Kit a compelling
solution to support the nation’s effort to reopen and limit
wild-type and variant viral spread.”
Under the re-issued EUA, serial testing of asymptomatic
individuals for SARS-CoV-2 requires individuals to be tested weekly
and with no more than seven days (168 hours) between serially
collected specimens. The re-issued EUA also further expands the
addressable market for the screening or diagnostic use of the Assay
Kit by authorizing the use of the KingFisher™ Flex Purification
System, a high-throughput robotic nucleic acid extraction system in
wide use by CLIA-certified laboratories nationally. With the
addition of the KingFisher system to the EUA, ADCL will have a
daily testing capacity of several thousand COVID-19 samples.
Dr. Hayward concluded, “The expanded intended use is also
complementary to safeCircleTM, our pooled surveillance COVID-19
testing platform. Together with CLIA certification, we can now
offer clients the choice between conventional physician-ordered
diagnostic testing, non-pooled individual screening testing, and
pooled surveillance testing, thereby allowing us to provide a range
of COVID-19 testing programs that can be tailored to meet the
unique testing requirements of a diverse range of clients.”
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 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 LineaTM 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 guidances. The use of saliva and pooled
sampling for surveillance testing, which has been internally
validated by the Company in compliance with current surveillance
testing guidances, 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 guidances 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 Form 10-Q filed on February
11, 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/20210512005536/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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