Applied DNA Applies for Linea Mpox Virus Test Expansion in NY

STONY BROOK, NY / ACCESSWIRE / August 19, 2024 – Applied DNA Sciences, Inc. (NASDAQ:APDN) has announced plans to expand the approved use of its Linea™ Mpox Virus 1.0 Assay to include the detection of mpox Clade I, following the World Health Organization's declaration of a public health emergency concerning this variant. The company’s internal data indicates that the assay can identify the genetic sequence of mpox Clade I, and it is currently conducting validation studies to support the necessary documentation for submission to the New York State Department of Health (NYSDOH). The Linea™ Mpox Virus 1.0 Assay was previously approved by NYSDOH in September 2022 for detecting mpox Clade II, formerly known as monkeypox. If the expansion is approved, Applied DNA will be able to offer clinical testing services for both Clade I and Clade II from its molecular diagnostics laboratory in Stony Brook, New York, serving samples from New York and other states that recognize New York’s certification. The company has issued a caution regarding forward-looking statements, highlighting the inherent risks and uncertainties associated with research and development. These include the potential for the assay to not be validated for Clade I detection or to receive NYSDOH approval, as well as challenges related to financial resources and market demand for mpox testing. Applied DNA has committed to transparency, stating it will not update its forward-looking statements unless legally required, and encourages stakeholders to review its SEC filings for further information.