Applied DNA Files Application with New York State Department of Health to Expand Intended Use of Linea Mpox Virus 1.0 Test to Mpox Clade I

STONY BROOK, NY / ACCESSWIRE / August 19, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, today announced that it plans to expand the approved intended use of its Linea Mpox Virus 1.0 Assay (the “Assay”) to include the detection of mpox Clade I, which is the subject of the August 14, 2024 declaration of a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO). The Company’s internally generated data demonstrate that the Assay can detect the genetic sequence of mpox Clade I and is now conducting validation studies to enable submission of the necessary documentation to the New York State Department of Health (NYSDOH). The Company plans to submit its NYSDOH application as soon as possible based on turnaround times for required reagents and control materials. There can be no assurance as to the timing of any NYSDOH approval or whether such approval will ever be granted.

The test was approved by NYSDOH in September 2022 as a laboratory-developed test for the detection of mpox Clade II (formerly monkeypox). If the test is approved for Clade I testing, the company will be able to provide clinical testing services at its CLEP/CLIA molecular diagnostics laboratory in Stony Brook, NY for mpox Clade I and Clade II on samples sourced from New York State and states that recognize New York’s CLEP/CLIA certification for testing.