On March 22, 2023 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in PCR-based DNA technologies, reported 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) (Press release, Applied DNA Sciences, MAR 22, 2023, View Source [SID1234629153]). If approved by NYSDOH, the LDT test will be used by ADCL to power its population-scale PGx testing services.
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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."
Footnotes:
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. View Source
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. View Source(22)01841-4. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01841-4/fulltext
3 View Source