Applied DNA To Submit Application to New York State Department of Health to Expand Intended Use of Linea Mpox Virus 1.0 Assay to Mpox Clade I
Rhea-AI Summary
Applied DNA Sciences (NASDAQ:APDN) has announced plans to expand the intended use of its Linea™ Mpox Virus 1.0 Assay to include detection of mpox Clade I, following the WHO's recent declaration of a public health emergency. The company's internal data suggests the assay can detect mpox Clade I's genetic sequence, and validation studies are underway to support a filing with the New York State Department of Health (NYSDOH).
If approved, Applied DNA could offer clinical testing services for both mpox Clade I and Clade II in its Stony Brook, N.Y. laboratory for samples from New York State and states recognizing New York's CLEP/CLIA certification. The assay is currently approved as a laboratory-developed test for mpox Clade II detection. The company emphasizes that the timing and approval of the NYSDOH filing are uncertain.
Positive
- Potential expansion of Linea™ Mpox Virus 1.0 Assay to detect mpox Clade I
- Internal data shows assay can detect mpox Clade I genetic sequence
- Possible increase in testing services if approved for both Clade I and II
Negative
- Uncertain timing and approval of NYSDOH filing
- to samples from New York State and states recognizing New York's certification
News Market Reaction
On the day this news was published, APDN gained 128.64%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
STONY BROOK, NY / ACCESSWIRE / August 19, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, today announced its intention to seek an expansion of the approved intended use of its Linea™ Mpox Virus 1.0 Assay (the "Assay") to include the detection of mpox Clade I that is the subject of the World Health Organization's (WHO) 14 August 2024 declaration of a public health emergency of international concern (PHEIC). The Company's internally generated data show that the Assay can detect the genetic sequence of mpox Clade I and is now undertaking validation studies to enable the filing of necessary documentation with the New York State Department of Health (NYSDOH). The Company plans to make its NYSDOH filing as soon as practicable based on the turnaround times for necessary reagents and control materials. No assurance can be given regarding the timing of any NYSDOH approval and whether such approval will ever be granted.
The Assay was approved as a laboratory-developed test for the detection of mpox Clade II (previously monkeypox) by NYSDOH in September 2022. If approved for the testing of Clade I, the Company could provide clinical testing services in its CLEP/CLIA 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.
Laboratory/Test Information
Applied DNA Clinical Labs, LLC ("ADCL") is a NYSDOH CLEP-permitted, Clinical Laboratory Improvement Amendments ("CLIA")-certified clinical laboratory, certified to perform high-complexity testing. The Linea™ Mpox Virus 1.0 Assay was developed, and its performance characteristics were determined by ADCL. The Linea™ Mpox Virus 1.0 Assay has not been cleared or approved by the U.S. Food and Drug Administration. The Linea™ Mpox Virus 1.0 Assay is intended for clinical purposes.
Forward-Looking Statements
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. Further, the uncertainties inherent in research and development, future data and analysis, including whether Linea Mpox Virus 1.0 Assay will, if ever, be validated for the detection of mpox Clade I in clinical samples or whether the Linea Mpox Virus 1.0 Assay will, if ever, receive approval from NYSDOH for the detection of mpox Clade I in clinical samples, and/or disruptions in the supply of raw materials and supplies In addition, actual results could differ materially from those projected due to the Company's history of net losses, the unknown demand, revenue and profits, if any, that will result from mpox testing, limited financial resources, and various other factors detailed from time to time in Applied DNA's SEC reports and filings, including its Annual Report on Form 10-K, as amended, filed on December 7, 2023, and Quarterly Report on Form 10-Q filed on February 8, 2024, May 10, 2024, and August 8, 2024, and other reports it files with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
Contacts:
Applied DNA Sciences
Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com
Web: www.adnas.com
Twitter: @APDN
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SOURCE: Applied DNA Sciences, Inc.
View the original press release on accesswire.com
FAQ
What is Applied DNA Sciences (APDN) planning to do with its Linea™ Mpox Virus 1.0 Assay?
Why is Applied DNA Sciences (APDN) seeking to expand its mpox assay?
What is the current status of Applied DNA Sciences' (APDN) Linea™ Mpox Virus 1.0 Assay?
Where can Applied DNA Sciences (APDN) provide clinical testing services for mpox if the expansion is approved?
