Applied DNA Submits Validation Package to NYSDOH for Mpox Clade I Detection Expansion

STONY BROOK, NY / ACCESSWIRE / August 23, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN), a leader in PCR-based DNA technologies, has announced that its clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has submitted a validation package to the New York State Department of Health (NYSDOH). This package supports the expansion of its Linea™ Mpox Virus 1.0 Assay to include detection of mpox clade I and clade II.

Validation studies confirmed the assay's primers and probe have 100% homology to both mpox clade I and clade Ib. Clade Ib is notable as it was the subject of a recent public health emergency declared by the World Health Organization (WHO).

The NYSDOH previously approved the assay for detecting mpox clade II in September 2022. If NYSDOH approves the expansion, the assay will be used to test for both clade I and clade II at ADCL’s molecular diagnostics laboratory in Stony Brook, NY. The timeline for NYSDOH's review is currently unknown.

ADCL is a CLEP-permitted, CLIA-certified clinical laboratory authorized to perform high-complexity testing. The Linea Mpox Virus 1.0 Assay is intended for clinical use and has not been cleared by the U.S. FDA.