Applied DNA Sciences to seek expansion of use of Linea Mpox Virus 1.0 Assay

Applied DNA Sciences announced its intention to seek an expansion of the approved intended use of its Linea Mpox Virus 1.0 Assay to include the detection of mpox Clade I that is the subject of the World Health Organization’s 14 August 2024 declaration of a public health emergency of international concern. The company’s internally generated data show that the Assay can detect the genetic sequence of mpox Clade I and is now undertaking validation studies to enable the filing of necessary documentation with the New York State Department of Health. The company plans to make its NYSDOH filing as soon as practicable based on the turnaround times for necessary reagents and control materials. No assurance can be given regarding the timing of any NYSDOH approval and whether such approval will ever be granted. The Assay was approved as a laboratory-developed test for the detection of mpox Clade II (previously monkeypox) 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.