Applied DNA Launches Monkeypox Testing Service

Rhea-AI Summary

Applied DNA Sciences (NASDAQ: APDN) has received full approval from the New York State Department of Health for its Monkeypox Virus Diagnostic test. This allows its laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), to provide monkeypox testing services to hospitals and clinical labs in New York and other states recognizing New York's certification. The test, designed to detect the Clade II variant of the monkeypox virus, aims to enhance testing capacity amidst over 20,000 reported cases in the U.S., with New York being severely affected.

Positive

• Received full approval from New York State Department of Health for monkeypox testing.
• ADCL is positioned as a rapid testing reference lab, enhancing its service offering.
• Test targets the prevalent Clade II variant of the monkeypox virus.

Negative

• Depends on ongoing public health emergency status for future service demand.

- Clinical Laboratory Receives Full Approval from New York State Department of Health for PCR-based Monkeypox Virus Diagnostic as Laboratory Developed Test -

STONY BROOK, N.Y.--(BUSINESS WIRE)-- 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.

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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.

View source 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

Source: Applied DNA Sciences, Inc.

FAQ

What recent approval did Applied DNA Sciences receive?

Applied DNA Sciences received full approval from the New York State Department of Health for its Monkeypox Virus Diagnostic test.

What is the significance of the monkeypox testing service launched by Applied DNA Sciences?

The monkeypox testing service enables rapid testing capabilities in New York, addressing the public health need amid a surge in cases.

How does the monkeypox test by Applied DNA Sciences work?

The test utilizes an A17L gene-target specific to the monkeypox virus Clade II, using real-time PCR for detection.

What market does Applied DNA Sciences' monkeypox test target?

The test targets hospital systems and clinical labs in New York and other states that recognize New York's testing certification.

How many monkeypox cases have been reported in the U.S.?

As of September 2, there are approximately 20,000 reported cases of monkeypox in the United States.