Applied DNA Sciences

Applied DNA Sciences, Inc. develops and markets DNA-based technology solutions for use in the nucleic acid-based in vitro diagnostics and preclinical nucleic-acid based drug development and manufacturing markets; and for supply chain security, anti-counterfeiting, and anti-theft technology purposes. The company's supply chain security and product authentication solutions include SigNature molecular tags that provide forensic power and protection for various applications used to fortify brand protection efforts and strengthen supply chain security, as well as mark, track, and convict criminals; SigNify IF portable DNA readers and SigNify consumable reagent test kits that provide real-time authentication of molecular tags in the field; and CertainT, which indicates the use of tagging, testing, and tracking platforms and solutions enabling manufacturers, brands, and trade organizations to convey proof of their product claims. It also manufactures and sells COVID-19 PCR-based molecular diagnostic test kit under the LineaTM COVID-19 Assay Kit trademark; and COVID-19 diagnostic test kit to prevent virus spread within a community, school, or workplace under the safeCircle trademark. In addition, the company provides preclinical contract research and manufacturing services for the nucleic acid-based therapeutic markets; and contract research services to RNA based drug and biologic customers for preclinical studies. Further, it develops an invasive circulating tumor cell capture and identification technology that uses a patented functional assay to capture live invasive circulating tumor cell and associated lymphocytes. The company operates in the United States, Europe, Asia, and internationally. The company was formerly known as Datalink Systems, Inc. and changed its name to Applied DNA Sciences, Inc. in 2002. Applied DNA Sciences, Inc. was founded in 1983 and is headquartered in Stony Brook, New York.

Applied DNA Sciences, Inc. (APDN)
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At close: May 31 04:00PM EDT
 

STONY BROOK, N.Y., September 06, 2022--(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