Applied DNA Receives Approval For TR8(TM) Pharmacogenomic (PGx) Testing Service From New York State Department Of Health
Applied DNA Sciences, Inc. ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today announced that the New York State Department of Health ("NYSDOH") approved the Company's TR8 PGx ("TR8") pharmacogenomic (PGx) testing service. The Company is currently in discussions to provide large-scale testing to enterprise customers, healthcare networks, and concierge physicians seeking to add PGx testing to their test menu.
Applied DNA's clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), is launching its PGx testing service to help guide healthcare providers to administer a wide range of medications relevant to cardiovascular, oncology, psychiatric, infectious disease, and pain management treatments based on a patient's unique genetics. The service is available by prescription only and will initially target the patient population of New York State.
"The standards set by NYSDOH are one of the most rigorous in the country, and the approval of our TR8 testing service marks a significant regulatory milestone for the Company. We believe New York State is a greenfield market for PGx testing, and we are actively recruiting testing volume through partnerships with employers, healthcare systems, and large-scale enterprises to establish market share," stated Dr. James A. Hayward, president and CEO of Applied DNA. "Launching this testing service delivers on our commitment to advance personalized medicine through cost-effective and scalable genetic testing for improved patient outcomes and reduced healthcare costs. We are pleased to bring to New Yorkers PGx testing, which we believe holds the enormous potential to help them live their healthiest lives."
TR8 PGx - Enterprise-scale Pharmacogenomic Testing
The TR8 PGx test analyzes 120 genetic targets across more than 30 genes to inform a healthcare provider how a patient may respond to a wide range of medications used to treat a variety of conditions, such as cardiovascular, oncology, psychiatric, and pain management. The test is administered via a simple cheek swab.
Equipped with information about a patient's genome-based response to medications, healthcare providers can make better decisions when selecting prescription medications that optimize healthcare quality and efficacy. Studies have shown that PGx testing can lower institutional healthcare costs, improve population wellness, and increase productivity when deployed in enterprise-scale applications, such as healthcare systems, institutions, and self-insured enterprises1,2,3,4, the latter accounting for approximately 65% of all U.S. employers in 20235.
For more information, visit TR8 PGx: https://adnas.com/pgx/.
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. 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
3 Bain KT, Knowlton CH, Matos A. Cost avoidance related to a pharmacist-led pharmacogenomics service for the Program of All-inclusive Care for the Elderly. Pharmacogenomics. 2020;21(10):651-661
4 Bradley P, Shiekh M, Mehra V, et al. Improved efficacy with targeted pharmacogenetic-guided treatment of patients with depression and anxiety: A randomized clinical trial demonstrating clinical utility. J Psychiatr Res. 2018;96:100-107. doi:10.1016/j.jpsychires.2017.09.024
5 https://www.statista.com/statistics/985324/self-funded-health-insurance-covered-workers/
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, through our recent acquisition of Spindle Biotech, Inc. ("Spindle"), 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.
For more information, visit adnas.com
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 TR8 test was developed, and its performance characteristics were determined by ADCL. The TR8 test has not been cleared or approved by the U.S. Food and Drug Administration. The TR8 test is intended for clinical purposes.
Source: Applied DNA Sciences