Applied DNA Submits Validation Package to New York State Department of Health to Expand Linea Mpox Virus 1.0 Assay to Mpox Clade I

Rhea-AI Summary

Applied DNA Sciences (NASDAQ:APDN) has submitted a validation package to the New York State Department of Health (NYSDOH) to expand its Linea™ Mpox Virus 1.0 Assay to include both mpox clade I and clade II. The company's validation studies confirmed that the assay's primers and probe have 100% homology to mpox clade I and clade Ib, the latter being the subject of the WHO's recent public health emergency declaration.

The assay was previously approved for detecting mpox clade II in September 2022. If approved for clade I, Applied DNA could provide clinical testing services for both clades in its Stony Brook, N.Y. laboratory for samples from New York State and states recognizing New York's CLEP/CLIA certification.

Positive

• Validation studies confirmed 100% homology to mpox clade I and clade Ib
• Potential expansion of testing capabilities to include both mpox clade I and clade II
• Previously approved for mpox clade II detection in September 2022

Negative

• Timeline for NYSDOH review of validation package is unknown
• No assurance of NYSDOH approval for expansion to clade I testing

Insights

Medical Research Analyst

The submission of a validation package to expand Applied DNA's Linea Mpox Virus 1.0 Assay to include both mpox clade I and clade II is a significant development. This expansion could potentially broaden the assay's utility in detecting different mpox variants, including the clade Ib strain that recently triggered a WHO public health emergency.

The reported 100% homology of the assay's primers and probe to mpox clade I and clade Ib is technically impressive. However, it's important to note that regulatory approval is pending and the timeline for NYSDOH's review is uncertain. If approved, this could position Applied DNA as a key player in comprehensive mpox testing, potentially increasing their market share in molecular diagnostics.

Financial Analyst

While the potential expansion of Applied DNA's mpox assay is promising, investors should exercise caution. The uncertain timeline for regulatory approval and the undisclosed financial impact make it difficult to quantify the immediate effect on the company's bottom line.

However, if approved, this could open new revenue streams for Applied DNA, particularly given the recent WHO declaration. The ability to test for both mpox clades could differentiate the company in the competitive diagnostics market. Investors should monitor for approval updates and subsequent testing volume increases as indicators of potential financial impact.

-Validation Studies Confirmed the Assay Can Detect Mpox Clade I and Clade Ib in addition to Clade II-

STONY BROOK, NY / ACCESSWIRE / August 23, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (the "Company"), a leader in PCR-based DNA technologies, today announced that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has submitted a validation package to the New York State Department of Health (NYSDOH) in support of an expansion of the permitted use of its Linea™ Mpox Virus 1.0 Assay (the "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, the latter of which was the subject of the World Health Organization's (WHO) recently declared public health emergency of international concern.

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

The Assay was previously approved as a laboratory-developed test for the detection of mpox clade II 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

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.

About Applied DNA Sciences

Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid ("DNA"). Using the polymerase chain reaction ("PCR") to enable both the production and detection of DNA, we operate in three primary business markets: (i) the enzymatic manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and the development and sale of a proprietary RNA polymerase ("RNAP") for use in the production of mRNA therapeutics; (ii) the detection of DNA and RNA in molecular diagnostics and genetic testing services; and (iii) the manufacture and detection of DNA for industrial supply chain security services.

Visit adnas.com for more information. Follow us on X and LinkedIn. Join our mailing list.

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 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.

Corporate Contacts:

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

View the original press release on accesswire.com

FAQ

What is the current status of Applied DNA's Linea Mpox Virus 1.0 Assay (APDN)?

Applied DNA (NASDAQ:APDN) has submitted a validation package to the NYSDOH to expand its Linea Mpox Virus 1.0 Assay to detect both mpox clade I and clade II. The assay is currently approved for clade II detection only.

When was Applied DNA's Linea Mpox Virus 1.0 Assay initially approved for clade II testing?

Applied DNA's Linea Mpox Virus 1.0 Assay was initially approved as a laboratory-developed test for the detection of mpox clade II by the New York State Department of Health in September 2022.

What were the results of Applied DNA's validation studies for the Linea Mpox Virus 1.0 Assay (APDN)?

Applied DNA's validation studies concluded that the Linea Mpox Virus 1.0 Assay's primers and probe have 100% homology to mpox clade I and clade Ib, in addition to its existing capability for clade II detection.

Where can Applied DNA (APDN) provide clinical testing services if the expanded assay is approved?

If approved, Applied DNA could provide clinical testing services for mpox clade I and clade II in its CLEP/CLIA molecular diagnostics laboratory in Stony Brook, N.Y., for samples from New York State and states recognizing New York's CLEP/CLIA certification.