Applied DNA Sciences, Inc. (APDN) experienced a significant stock price increase on Friday, fueled by a surge in trading volume. This upward trend followed the company’s submission of a validation package to the New York State Department of Health (NYSDOH). The package aims to broaden the application of their Linea Mpox Virus 1.0 Assay to encompass both clade I and clade II of the mpox virus.
The company’s validation studies revealed a 100% homology between the assay’s primers and probe and both mpox clade I and clade Ib. This finding suggests the assay’s potential to accurately detect both clades. The timeline for NYSDOH’s review of the validation package remains unclear, and there is no guarantee of approval for the expanded use of the assay. However, if approved, Applied DNA Sciences could provide clinical testing services for mpox clade I and clade II in its molecular diagnostics laboratory in Stony Brook, New York. This would extend their testing services to samples originating in New York and other states recognizing New York’s CLEP/CLIA certification.
This development comes in the wake of the World Health Organization’s declaration of an international public health emergency concerning mpox. This declaration has raised concerns about travel to Africa and contributed to an increase in the trading volume of mpox-related stocks.
The Linea Mpox Virus 1.0 Assay was developed for clinical purposes and has been assessed by Applied DNA Sciences (ADCL) for its performance characteristics. It’s important to note that the U.S. Food and Drug Administration (FDA) has not cleared or approved the assay.
Currently, authorities in Europe and China are expediting screening efforts to detect a new and potentially deadly variant of mpox. This variant has spread across regions of Africa and has been identified in Europe.
The surge in APDN stock reflects the potential market opportunity for a test capable of detecting both mpox clades. However, it is crucial to remember that the approval process for the expanded use of the assay is ongoing, and there is no certainty of success.
