Applied DNA Launches Monkeypox Testing Service
September 06 2022 - 8:00AM
Business Wire
- Clinical Laboratory Receives Full Approval
from New York State Department of Health for PCR-based Monkeypox
Virus Diagnostic as Laboratory Developed Test -
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 launched monkeypox testing as a
clinical reference laboratory testing service available to hospital
systems and clinical labs located in New York State and in states
that recognize New York's CLEP/CLIA certification for testing.
The launch follows ADCL’s receipt of full approval from the New
York State Department of Health (NYSDOH) for its Linea™ Monkeypox
Virus 1.0 Assay as a Laboratory Developed Test (LDT) for the
detection of the Clade II variant of the monkeypox virus that is
currently prevalent in the U.S. As of September 2, according to the
CDC, there are approximately 20,000 cases of monkeypox in the
United States with New York State reporting the second-highest
number of infections nationally.
“We believe we can play a key role in increasing rapid
turn-around-time (“TAT”) monkeypox testing capacity to support
healthier communities in our operating area of Long Island and New
York City, and, more broadly, in New York State and other states
that allow samples to be sent to New York labs for testing. Having
built ADCL’s stellar reputation for high-capacity, PCR-based
COVID-19 testing with rapid TAT, we believe we can bring to bear
the same expertise to the monkeypox public health emergency,”
stated Dr. James A. Hayward, president and CEO of Applied DNA
Sciences.
“With NYSDOH full approval now in hand, we are positioning ADCL
as a rapid TAT reference lab to hospital systems and clinical labs
who have suspected monkeypox cases but have not developed a
diagnostic or cannot return results in clinically relevant times,”
continued Dr. Hayward. “We believe that operating as a reference
lab is a strategic business model that allows ADCL to focus on what
it does best – delivering cost effective, turnkey, and rapid TAT
clinical testing services to high-volume clients. In addition, we
are moving to bring our new testing capability to the attention of
institutions that maintain congregate living settings that we
believe could be high-risk environments for the spread of
contact-based monkeypox.”
ADCL’s monkeypox test utilizes an A17L gene-target specific to
monkeypox virus Clade II that enables the qualitative detection and
differentiation of the monkeypox virus from other non-variola
orthopoxviruses using real-time PCR. Testing will be performed at
ADCL’s CLEP/CLIA molecular diagnostics laboratory in Stony Brook,
N.Y., utilizing its established and proven workflows to ensure
accurate results and competitive turnaround times.
To learn more about ADCL’s monkeypox testing service, click to:
adnas.com/monkeypox-testing
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,
the unknown future path of the monkeypox virus public health
emergency, 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/20220906005366/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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