Applied DNA Submits Validation Package to New York State Department of Health to Expand Linea Mpox Virus 1.0 Test to Mpox Clade I

-Validation studies confirm that the test can detect Mpox Clade I and Clade Ib in addition to Clade II-

STONY BROOK, NY / ACCESSWIRE / August 23, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (the “Company”), a leader in PCR-based DNA technologies, today announced that its wholly owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has submitted a validation package to the New York State Department of Health (NYSDOH) in support of an expansion of the permitted use of its Linea Mpox Virus 1.0 Assay (the “Assay”) to include both mpox clade I and clade II. The Company’s validation studies concluded that the Assay’s primers and probe have 100% homology to mpox clade I and clade Ib, the latter of which was the subject of a recent declaration of a Public Health Emergency of International Concern by the World Health Organization (WHO).

The timeline for NYSDOH’s review of the company’s validation package is currently unknown, and there can be no assurance that NYSDOH will approve the company’s requested expansion of the test to clade I.