Applied DNA Submits PCR-based Monkeypox Virus Diagnostic Test for Approval to New York State Department of Health
August 19 2022 - 9:45AM
Business Wire
- Submitted by Clinical Lab Subsidiary for its
Use; Subsidiary to Manufacture the Diagnostic Kit if Approved -
Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the
"Company"), a leader in PCR-based DNA technologies, announced today
that its wholly-owned clinical laboratory subsidiary, Applied DNA
Clinical Labs, LLC ("ADCL"), has submitted to the New York State
Department of Health (NYSDOH) a validation package for its
Company-developed monkeypox virus test in support of a request for
full approval as a form of NYSDOH Laboratory Developed Test (LDT).
The PCR-based diagnostic is designed to identify the genetic
signature of the Clade II variant of the monkeypox virus that is
currently prevalent in the U.S. If approved by NYSDOH, the test
will be used to power ADCL's monkeypox testing services.
Named the Linea™ Monkeypox Virus 1.0 Assay, the test would be
ADCL's second successful LDT in less than one year if approved by
the NYSDOH. The test is part of ADCL's high-throughput infectious
disease testing offering centered on high-volume testing for
infectious diseases that can reoccur within a population. ADCL's
Linea™ 2.0 COVID-19 Assay received conditional approval as an LDT
from NYSDOH in January 2022 and currently powers ADCL's COVID-19
testing services. If approved, monkeypox testing will be performed
at ADCL's CLEP/CLIA molecular diagnostics laboratory in Stony
Brook, N.Y., utilizing proven workflows to ensure accurate results
and competitive turnaround times.
"Our pursuit of monkeypox testing via LDT combines what we
believe to be the quickest regulatory path for diagnostic approval
with our proven ability to deliver short turnaround time-to-results
that, as COVID-19 has taught us, can help contain virus spread,"
stated Dr. James A. Hayward, president and CEO of Applied DNA.
"Upon NYSDOH approval, ADCL has the testing capacity to deploy to
help keep New Yorkers safe. Moreover, as the test kit manufacturer,
we maximize the control over our own supply chain to ensure both
quality and availability."
About Applied DNA Sciences
Applied DNA Sciences is a biotechnology company developing
technologies to produce and detect deoxyribonucleic acid ("DNA").
Using PCR to enable both the production and detection of DNA, we
operate in three primary business markets: (i) the manufacture of
DNA for use in nucleic acid-based therapeutics; (ii) the detection
of DNA in molecular diagnostics testing services; and (iii) the
manufacture and detection of DNA for industrial supply chain
security services.
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 the ticker
symbol 'APDN,' and its publicly traded warrants are listed on OTC
under the 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 its history of
net losses, limited financial resources, limited market acceptance,
the possibility that Applied DNA's testing services could become
obsolete or have their utility diminished and the unknown amount of
revenues and profits that will results from Applied DNA's testing
services. Further, the uncertainties inherent in research and
development, future data and analysis, including whether any of
Applied DNA's current or future diagnostic candidates will advance
further in the research and/or validation process or receiving
authorization, clearance or approval from the FDA, equivalent
foreign regulatory agencies and/or the 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,
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 9, 2021, its Quarterly Report on Form 10-Qs filed
on February 10, 2022, May 12, 2022, and August 11, 2022, 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/20220819005040/en/
Investor Relations Contact: Sanjay M. Hurry,
917-733-5573, sanjay.hurry@adnas.com ADCL Program Contact:
Mike Munzer, 631-240-8814, mike.munzer@adnas.com Web:
www.adnas.com Twitter: @APDN
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