Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the
“Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA
manufacturing, today announced that its Applied DNA Clinical Labs,
LLC (ADCL) subsidiary received CLIA (Clinical Laboratory
Improvement Amendments) certification from the New York State
Department of Health Clinical Laboratory Evaluation Program (CLEP)
for COVID-19 testing using EUA-authorized methods and devices. With
this certification, ADCL can now serve as a diagnostic laboratory
to conduct high throughput diagnostic COVID-19 testing utilizing
EUA-authorized testing platforms, including the Company’s Linea™
COVID-19 Assay Kit. ADCL’s CLIA certification umbrella includes its
Limited Service Laboratory (LSL) certification for Point-of-Care
testing using COVID-19 molecular and antigen assays and community
screening applications for COVID-19 and influenza.
With certification, ADCL can now pursue diagnostic COVID-19
testing for regional healthcare providers and overflow business
from third-party and hospital clinical labs. Certification will
also allow ADCL to capture a greater percentage of the economics of
its safeCircle™ service by conducting confirmatory diagnostic
testing in-house.
“CLIA certification is the cornerstone of our ADCL strategy that
serves to broaden our COVID-19 testing opportunity in the near-term
while catalyzing additional diagnostic opportunities in the
future,” said Dr. James A. Hayward, president and CEO, Applied DNA.
“With certification in hand, we believe our capacity to process
thousands of samples a day consistently, paired with the accuracy
of our Assay Kit and its capacity for variant discrimination, and
typically same-day-to-24-hour turnaround times, give us a very
compelling market presence moving forward.”
About the Linea™ COVID-19 Assay
Kit
The Linea™ COVID-19 Assay Kit is authorized by FDA EUA 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. 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.
About safeCircle™
ADCL’s pooled surveillance testing program, known as safeCircle,
utilizes frequent, high-sensitivity pooled testing to help prevent
virus spread by quickly identifying infections within a community,
school, or workplace. safeCircle provides 24-hour results using
real-time PCR (RT-PCR) testing.
Click through to learn more about how safeCircle can help your
community, school, and workplace: safeCircle
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.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210511005756/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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