Applied DNA Sciences (APDN) Launches Monkeypox Testing Service

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

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