Applied DNA Submits Monkeypox Test to DOH

STONY BROOK, NY –Applied DNA Sciences, Inc.  announced 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).

Shares in the company (Symbol: APDN) have surged over 400% since announcing the development of the new monkeypox test earlier this month.

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, 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.”

Monkeypox spreads through close, physical contact between people. This means anyone can get monkeypox. However, based on the current outbreak, certain populations are being affected by monkeypox more than others, including men who have sex with men (MSM).

Based on previous outbreaks of monkeypox around the world, some groups may also be at heightened risk for severe outcomes if they contract monkeypox. This includes people with weakened immune systems, elderly New Yorkers, young children under 8 years of age, and pregnant people.