APDN Stock Rises Dramatically Following Mpox Assay Validation Submission
APDN Stock Surge – Applied DNA Sciences, Inc. (NASDAQ: APDN) saw a significant increase in its stock price on Friday, rising by 42.10% to $2.61. This surge was accompanied by a robust trading volume of 114.23 million shares, sharply up from the average volume of 6.78 million shares, according to Benzinga Pro data.
Validation Package Submission to NYSDOH
The surge in APDN’s stock comes as the company advances its Linea Mpox Virus 1.0 Assay, having submitted a validation package to the New York State Department of Health (NYSDOH). The submission seeks to expand the assay’s usage to include both mpox clade I and clade II, following its prior approval for detecting pox clade II as a laboratory-developed test in September 2022.
Validation Study Results
Applied DNA Sciences’ validation studies have confirmed that the assay’s primers and probe exhibit 100% homology to mpox clade I and clade Ib. However, the timeline for NYSDOH’s review and approval of this expansion request is currently unknown, and there is no guarantee that the department will grant approval for the inclusion of clade I.
Impact of WHO’s International Health Emergency
The company’s recent activities come in the wake of an international public health emergency declared by the World Health Organization (WHO) due to mpox. This declaration has heightened global awareness and concern regarding the virus, particularly in relation to travel to Africa. Consequently, stocks related to mpox have experienced a notable increase.
Future Prospects and Regional Testing
If NYSDOH approves the expansion to include clade I, Applied DNA Sciences could provide clinical testing services for both mpox clade I and clade II through its molecular diagnostics laboratory in Stony Brook, New York. This would extend the company’s testing capabilities to samples originating from New York State and other states that recognize New York’s CLEP/CLIA certification.
Regulatory Status and Global Screening Efforts
The Linea Mpox Virus 1.0 Assay, developed for clinical purposes, has not yet received clearance or approval from the FDA. Meanwhile, European and Chinese authorities are expediting screening processes for a new, more deadly variant of mpox that has emerged in Africa and has now been detected in Europe.
Summary
The significant rise in Applied DNA Sciences’ stock reflects increased investor interest driven by the company’s ongoing efforts to validate and expand its mpox testing capabilities, coupled with the global health crisis surrounding the virus.
FAQs: Applied DNA Sciences’ Recent Developments
What caused the recent increase in Applied DNA Sciences’ (APDN) stock price?
The recent increase in APDN’s stock price, which surged by 42.10% to $2.61, is primarily attributed to the company’s submission of a validation package to the New York State Department of Health (NYSDOH). This package aims to expand the use of their Linea Mpox Virus 1.0 Assay to include additional mpox clades, and is also influenced by the World Health Organization’s declaration of an international health emergency over mpox.
What is the Linea Mpox Virus 1.0 Assay, and what expansion is Applied DNA Sciences seeking?
The Linea Mpox Virus 1.0 Assay is a PCR-based test developed to detect mpox virus clade II. Applied DNA Sciences has submitted a validation package to NYSDOH to expand the assay’s use to include both mpox clade I and clade II. This expansion would allow the assay to detect a broader range of mpox virus variants.
What have the validation studies shown about the assay?
Validation studies have confirmed that the assay’s primers and probe exhibit 100% homology to mpox clade I and clade Ib. This high degree of homology indicates that the assay is highly specific to these mpox clades.
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