Why Is Diagnostic Tests Provider Applied DNA Sciences Stock Trading Higher On Friday?

Applied DNA Sciences, Inc. APDN stock traded higher on Friday on a strong session volume of 114.23 million, compared to the average volume of 6.78 million, according to data from Benzinga Pro.

The PCR-based DNA technologies submitted a validation package to the New York State Department of Health (NYSDOH) to expand 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.

Also Read: Mpox Vaccine Maker Bavarian Nordic Targets Broader Access With European Submission For Imvanex Adolescent Use During WHO Emergency.

The timeline for NYSDOH’s review of the company’s validation package is not currently known. There can be no assurances that NYSDOH will approve the company’s requested expansion of the Assay to clade I.

Last week, the World Health Organization issued an international public health emergency over mpox, leading to increased concern around travel to Africa and causing mpox stocks to trade higher once again.

NYSDOH approved the Assay in September 2022 as a laboratory-developed test for the detection of pox clade II.

If approved for the testing of clade I, the company could provide clinical testing services in its 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.

ADCL determined the performance characteristics of the Linea Mpox Virus 1.0 Assay, which was developed for clinical purposes. However, the FDA has not cleared or approved it.

Authorities in Europe and China are expediting screening for a deadly new version of mpox that has spread across regions of Africa and has been found in Europe.

Price Action: APDN stock is up 42.10% at $2.61 at the last check on Friday.

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