Applied DNA Submits PCR-based Monkeypox Virus Diagnostic Test for Approval to New York State Department of Health
- Submitted by Clinical Lab Subsidiary for its Use; Subsidiary to Manufacture the Diagnostic Kit if Approved -
Named the Linea™ Monkeypox Virus 1.0 Assay, the test would be ADCL's second successful LDT in less than one year if approved by the NYSDOH. The test is part of ADCL's high-throughput infectious disease testing offering centered on high-volume testing for infectious diseases that can reoccur within a population. ADCL's Linea™ 2.0 COVID-19 Assay received conditional approval as an LDT from NYSDOH in
"Our pursuit of monkeypox testing via LDT combines what we believe to be the quickest regulatory path for diagnostic approval with our proven ability to deliver short turnaround time-to-results that, as COVID-19 has taught us, can help contain virus spread," stated Dr.
The Company's common stock is listed on NASDAQ under the ticker symbol 'APDN,' and its publicly traded warrants are listed on OTC under the ticker symbol' APPDW.'
The statements made by Applied DNA in this press release may be "forward-looking" in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA's future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance, the possibility that Applied DNA's testing services could become obsolete or have their utility diminished and the unknown amount of revenues and profits that will results from Applied DNA's testing services. Further, the uncertainties inherent in research and development, future data and analysis, including whether any of Applied DNA's current or future diagnostic candidates will advance further in the research and/or validation process or receiving authorization, clearance or approval from the FDA, equivalent foreign regulatory agencies and/or the NYSDOH, and whether and when, if at all, they will receive final authorization, clearance or approval from the FDA, equivalent foreign regulatory agencies and/or NYSDOH, the unknown outcome of any applications or requests to FDA, equivalent foreign regulatory agencies and/or the NYSDOH, disruptions in the supply of raw materials and supplies, and various other factors detailed from time to time in Applied DNA's