Applied DNA To Seek Approval for Expanded Use of Linea Mpox Virus 1.0 Assay

Applied DNA Sciences, Inc. (NASDAQ:APDN) announced plans to expand the approved use of its Linea™ Mpox Virus 1.0 Assay. The company aims to include the detection of mpox Clade I, following the World Health Organization's recent public health emergency declaration. Internal data suggests the Assay can detect the genetic sequence of mpox Clade I, prompting validation studies for submission to the New York State Department of Health (NYSDOH).

The Linea™ Mpox Virus 1.0 Assay, approved in September 2022 for mpox Clade II detection, could offer clinical testing for both Clade I and II if approved. Applied DNA intends to complete the NYSDOH filing promptly, contingent on reagent and material availability. Approval timing remains uncertain.

Applied DNA Clinical Labs, LLC, certified for high-complexity testing, developed the Assay. It is crucial to note that the Assay has not been cleared by the U.S. Food and Drug Administration and is intended solely for clinical purposes.

Forward-looking statements in the press release highlight associated risks, including validation and approval uncertainties, and are based on assumptions that may not materialize.