Applied DNA Receives Approval for TR8(TM) Pharmacogenomic (PGx) Testing Service from New York State Department of Health
Applied DNA Sciences (NASDAQ:APDN) announced that its TR8(TM) pharmacogenomic (PGx) testing service has received approval from the New York State Department of Health (NYSDOH). The service, offered through Applied DNA Clinical Labs, aims to help healthcare providers tailor medication treatments for cardiovascular, oncology, psychiatric, infectious disease, and pain management based on a patient's genetic profile. TR8(TM) analyzes 120 genetic targets across more than 30 genes using a cheek swab to inform healthcare providers about a patient's response to medications. The company sees this approval as a significant milestone and is actively seeking partnerships to expand its market share in New York State.
- Approval from NYSDOH for TR8(TM) PGx testing service signifies a significant regulatory milestone.
- TR8(TM) PGx testing targets a wide range of medical treatments including cardiovascular, oncology, psychiatric, infectious disease, and pain management.
- The test analyzes 120 genetic targets across more than 30 genes, providing comprehensive genetic insights.
- The service is designed to optimize healthcare quality and efficacy by tailoring medications based on genetic profiles.
- Potential to lower healthcare costs and improve patient outcomes.
- Active recruitment of testing volume through partnerships with employers, healthcare systems, and large-scale enterprises.
- Initial target market is to New York State, potentially restricting immediate revenue growth.
- Dependence on enterprise customers and healthcare networks for large-scale adoption may pose a risk if partnerships are not secured.
- The market for PGx testing is still emerging, which may lead to slower-than-expected adoption rates.
The approval of Applied DNA's TR8 PGx testing service by the NYSDOH signifies a substantial stride in personalized medicine. This service leverages pharmacogenomics, which is the study of how genes affect a person’s response to drugs. By analyzing 120 genetic targets across more than 30 genes, TR8 can significantly enhance the precision of treatments in key areas such as cardiovascular, oncology, psychiatric and pain management. This tailored approach could reduce adverse drug reactions and improve overall treatment outcomes.
Furthermore, with New York considered a rigorous market due to its stringent health standards, this approval potentially sets a precedent for other states and contributes to standardizing PGx testing in the U.S. healthcare system. For investors, this not only represents the company's commitment to advancing healthcare but also opens up a considerable market opportunity, given the growing demand for personalized medicine.
In the long term, the widespread adoption of PGx testing could lead to reduced healthcare costs by minimizing ineffective treatments and hospital readmissions, ultimately making the company's offering more attractive to healthcare providers and patients alike.
From a market perspective, the introduction of TR8 PGx testing holds significant promise. By targeting enterprise customers, healthcare networks and concierge physicians, Applied DNA is positioning itself strategically in the healthcare market. The focus on large-scale testing can lead to substantial revenue streams, particularly if the company can successfully establish partnerships with major healthcare systems and self-insured enterprises, which represent a sizeable segment of the market.
Additionally, the ability to lower healthcare costs and improve patient outcomes through precise medication management can be a strong selling point. Employers and healthcare providers are increasingly looking for ways to enhance employee health while managing costs. As TR8 PGx testing aligns well with these goals, it may see a broader adoption across various sectors.
However, it's important to monitor how quickly and effectively the company can scale this service and secure significant partnerships. Market penetration and competition from other PGx testing services could impact the projected growth and market share of Applied DNA.
STONY BROOK, NY / ACCESSWIRE / June 13, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("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
To learn more about 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.
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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.
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. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, unknown future demand for its PGx testing service, the unknown amount of revenues and profits that will result from our PGx testing service, the unknown status of FDA's continued enforcement discretion with respect to laboratory developed tests including laboratory developed PGx tests, 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, and May 10, 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.
Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com
Program contact: pgx@adnas.com
Web: www.adnas.com
Twitter: @APDN
SOURCE: Applied DNA Sciences, Inc.
View the original press release on accesswire.com
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