Applied DNA submits validation package to NYS Department of Health

Applied DNA Sciences announced that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, has submitted a validation package to the New York State Department of Health in support of an expansion of the permitted use of its Linea Mpox Virus 1.0 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 the World Health Organization’s recently declared public health emergency of international concern. The timeline for NYSDOH’s review of the Company’s validation package is not currently known and there can be no assurances that NYSDOH will approve the Company’s requested expansion of the Assay to clade I. The Assay was previously approved as a laboratory-developed test for the detection of mpox clade II by NYSDOH in September 2022. If approved for the testing of clade I, the Company could provide clinical testing services in its CLEP/CLIA molecular diagnostics laboratory in Stony Brook, N.Y. for mpox clade I and clade II on samples originating in New York State and in states that recognize New York’s CLEP/CLIA certification for testing.