Applied DNA Submits Validation Package to New York State Department of Health for Approval of Pharmacogenomic (PGx) Assay
March 22, 2023 at 09:35 AM EDT
- Expansion of Population-Scale Molecular Diagnostics Menu Positions ADCL Subsidiary for Long-Term Growth -
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 approval for a pharmacogenomics (PGx) assay as a NYSDOH laboratory-developed test (LDT). If approved by NYSDOH, the LDT test will be used by ADCL to power its population-scale PGx testing services.
ADCL’s PGx testing will focus on population-scale testing that is expected to be accretive to ADCL’s margin profile. ADCL’s commercial strategy is centered on the direct-to-enterprise and self-insured health markets that do not require ADCL to seek third-party reimbursement or engage in individual patient billing. In advance of initiating its PGx testing services, the Company’s sales outreach has targeted regional health systems and large, self-insured entities in its New York operating area and in States that recognize New York’s CLEP/CLIA certification.
PGx testing is a data-driven approach that relates an individual’s genetic factors to variable responses to prescription drugs. ADCL’s PGx assay interrogates 120 targets across 37 genes relevant to a broad range of common drugs, including cardiac, pain management, cancer, and mental health therapies. PGx testing yields actionable information to empower healthcare providers to deliver precision medicine to their patients through personalized drug prescribing and dosing.
Recently published studies have shown that population-scale PGx testing can significantly reduce overall population healthcare costs, reduce adverse drug events, and increase population wellbeing1,2. These benefits can result in significant cost savings to large entities and self-insured employers, the latter accounting for approximately 65% of all U.S. employers in 20223.
“PGx testing is a logical first step into the promising field of personalized medicine that brings together ADCL’s demonstrated capacity for population-scale testing and PGx’s proven benefits to the individual. When applied to large populations, we believe that the combination will generate significant healthcare cost reductions for enterprises and overall wellness benefits to employees,” stated Dr. James A. Hayward, president and CEO of Applied DNA Sciences. “Given PGx testing’s attractive margin profile and ongoing conversations with prospective customers, we view this first genetic assay as the basis for a long-term, profitable testing service.”
1 Jarvis, J. P., Peter, A. P., Keogh, M., Baldasare, V., Beanland, G. M., Wilkerson, Z. T., Kradel, S., & Shaman, J. A. (2022). Real-world impact of a pharmacogenomics-enriched comprehensive medication management program. Journal of Personalized Medicine, 12(3), 421. https://doi.org/10.3390/jpm12030421
2 Jesse J Swen, Cathelijne H van der Wouden, et al., A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study, The Lancet, Volume 401, Issue 10374, 2023, pages 247-356. https://doi.org/10.1016/S0140-6736(22)01841-4. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01841-4/fulltext
About Applied DNA Sciences
Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid (“DNA”). Using PCR to enable both the production and detection of DNA, we operate in three primary business markets: (i) the manufacture of DNA for use in nucleic acid-based therapeutics; (ii) the detection of DNA in molecular diagnostics testing services; and (iii) the manufacture and detection of DNA for industrial supply chain security services.
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, unknown future demand for its biotherapeutics and diagnostics/genetics products and services and the unknown amount of revenues and profits that will result from any diagnostic or genetic testing contracts. Further, the uncertainties inherent in research and development, future data and analysis, and applications to regulatory bodies including whether any of Applied DNA's current or future diagnostic and/or genetic testing 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 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 filed on December 14, 2022 as amended, its form 10-Q filed on February 9, 2023 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.
“Given PGx testing’s attractive margin profile and ongoing conversations with prospective customers, we view this first genetic assay as the basis for a long-term, profitable testing service.”