Applied DNA Receives FDA Emergency Use Authorization for COVID-19 Diagnostic Assay Kit
May 14 2020 - 5:00AM
Business Wire
- Advanced Single Well Assay Designed for
High-Throughput Testing -
Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the
“Company,” “our”) announced today that the U.S. Food and Drug
Administration (FDA) has provided Emergency Use Authorization (EUA)
for the clinical use of the Company’s patent-pending Linea™
COVID-19 RT-PCR test for COVID-19. Clinical laboratories in the
United States certified under Clinical Laboratory Improvement
Amendments (CLIA) to perform hi complexity tests. CLIA labs can
immediately begin ordering and using the Linea™ COVID-19 assay kit
to detect SARS-CoV-2, the virus that causes COVID-19.
The Linea™ COVID-19 assay kit is an rRT-PCR (reverse
transcription, Real Time Polymerase Chain Reaction)-based assay
designed to detect specific highly conserved target sequences of
the SARS-CoV-2 Spike (S) gene. The Linea™ COVID-19 assay is an
advanced single-well multiplex test that allows for simple set up
and higher-throughput as compared to tests that require multiple
wells per test. The Linea™ COVID-19 assay is approved to run on the
FDA-approved Applied Biosystems QuantStudio™ Dx real-time PCR
instrument, which allows for testing results for up to 94 samples
within one hour, or more than 2,000 tests in 24 hours per
device.
“I am very proud of our development team, who, despite the
challenges presented by the current global pandemic, developed our
Linea™ COVID-19 assay kit, filed patent applications, established
supply chain relationships, developed our initial customer
prospects and secured FDA EUA approval all within record time,”
said Dr. James A. Hayward, president and CEO of Applied DNA. “This
extraordinary achievement highlights the Company’s commitment to
combating the COVID-19 pandemic both locally and nationwide. We
also thank our neighbor and collaborator Stony Brook University
Hospital for its invaluable assistance.”
Dr. Mohan Chellani, Director of Diagnostic Regulatory Affairs at
Applied DNA and a 30-year veteran of the RNA-based molecular
diagnostics industry, stated, “We believe we have developed an
assay with numerous commercial advantages over other EUA approved
COVID-19 detections assays. We developed the Linea™ COVID-19 assay
kit for high-throughput operations where rapid high-volume testing
is requisite. In addition, we have worked closely with our supply
chain partners to evolve safeguards to ensure a steady supply of
inputs necessary for the construction of our kit.”
For more information on the Linea™ COVID-19 assay kit, please
visit www.adnas.com/dxcovid.
The Company notes that while the Linea™ COVID-19 assay kit has
been approved by FDA under an EUA for clinical use in CLIA
certified labs for the detection of SARS-CoV-2 RNA, the Linea™
COVID-19 assay kit has not been FDA cleared or approved. However,
the FDA can issue an EUA to permit use of certain medical products
that may be effective in diagnosing, treating or preventing a
disease or condition, as in the case of the novel coronavirus when
the secretary of the U.S. Department of Health and Human Services
(HHS) declares a public health emergency. HHS Secretary Alex Azar
declared an emergency for COVID-19 on January 31, 2020. The Linea™
COVID-19 assay kit is only authorized for the duration of the
declaration that circumstances exist justifying the authorization
of emergency use of in vitro diagnostic tests for detection and/or
diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C.
§ 360bbb-3(b)(1), unless the authorization is terminated or revoked
sooner. The Linea™ COVID-19 assay kit has been authorized only for
the detection of nucleic acids from SARS-CoV-2, not for any other
virus or pathogen.
In addition, the use of the Linea™ COVID-19 assay kit is
indicated for the qualitative detection of nucleic acid from
SARS-CoV-2 in upper respiratory specimens including nasal swabs,
self-collected at a healthcare location or collected by a
healthcare worker, and nasopharyngeal swabs and oropharyngeal
swabs, nasopharyngeal wash/aspirate or nasal aspirates collected by
a healthcare worker from individuals who are suspected of COVID-19
by their healthcare provider. The Linea™ COVID-19 assay kit has
been authorized only for the detection of nucleic acids from
SARS-CoV-2, not for any other virus or pathogen.
About Applied DNA Sciences, Inc.
Applied DNA is a provider of molecular technologies that enable
supply chain security, anti-counterfeiting and anti-theft
technology, product genotyping, diagnostics and pre-clinical
nucleic acid-based therapeutic drug candidates.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc.
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’.
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 the possibility
of a failure to make timely payment on its outstanding secured
convertible notes and resulting enforcement by noteholders of
remedies on collateral which includes substantially all of Applied
DNA’s assets, its history of net losses, limited financial
resources, limited market acceptance, the uncertainties inherent in
research and development, future clinical data and analysis,
including whether any of Applied DNA’s or its partners diagnostic
or therapeutic candidates will advance further in the preclinical
research or clinical trial process, including receiving clearance
from the U.S. Food and Drug Administration 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 to U.S. FDA or equivalent foreign regulatory
agencies, the unknown duration of this or any EUA approval,
disruptions in the supply of raw material 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 12, 2019 and our subsequent quarterly report on Form
10-Q filed on February 6, 2020, 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/20200514005271/en/
Investor contact: Sanjay M. Hurry, LHA Investor
Relations, 212-838-3777, shurry@lhai.com Program contact:
Mohan Chellani, Applied DNA, 631-240-8834, mohan.chellani@adnas.com
web: www.adnas.com, https://adnas.com/dxcovid
twitter: @APDN
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