Applied DNA Receives Approval for TR8(TM) Pharmacogenomic (PGx) Testing Service From New York State Department of Health
Applied DNA Receives Approval for TR8(TM) Pharmacogenomic (PGx) Testing Service From New York State Department of Health
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.
应用DNA科技公司(NASDAQ:APDN)是PCR基因检测技术领导者,今天宣布纽约州卫生部(NYSDOH)批准了该公司的TR8 PGx ("TR8")药物基因检测服务。公司正在与企业客户,医疗网络和私人医生合作进行大规模检测。这些机构和医生都希望在检测菜单中增加PGx检测。
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.
应用DNA的临床实验室子公司,应用DNA临床实验室有限责任公司(ADCL)正在推出其PGx检测服务,帮助医疗保健提供者根据病人的独特基因来使用治疗心血管,肿瘤,精神疾病,传染病和疼痛管理的各种药物。该服务仅限处方,最初将以纽约州病人为目标。
"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."
“纽约州的标准是全国最严格的之一。我们的TR8检测服务获得批准,标志着公司取得了重要的监管里程碑。我们认为,纽约州是PGx检测的可持续市场,我们正在积极与企业,医疗系统和大型企业合作,以确立市场份额,” 应用DNA公司总裁兼首席执行官詹姆斯·A·海沃德博士表示。“推出这项检测服务是我们为推进个性化医疗而承诺通过成本效益和可扩展的基因检测来改善患者治疗结果和降低医疗成本。我们很高兴为纽约人带来PGx检测,我们相信这将极大潜力帮助他们享受健康的人生。”
TR8 PGx - Enterprise-scale Pharmacogenomic Testing
TR8 PGx - 企业级药物基因检测
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.
TR8 PGx检测分析30多个基因中的120个遗传靶点,以告知医疗保健提供者病人可能对多种治疗心血管,肿瘤,精神疾病和疼痛管理的药物的反应。这项检测通过简单的唾液DNA检测进行。
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.
通过得到有关病人基于基因组的药物反应的信息,医疗保健提供者可以在选择处方药物时作出更好的决策,从而优化医疗质量和功效。研究表明,在企业级应用中部署PGx检测,如医疗系统,机构和自负一部分企业,即美国所有雇主的约65%,可以降低机构保健成本,改善人群健康和提高生产力。1,2,3,4关于美国所有雇主在2023年占比约65%。5.
To learn more about TR8 PGx:
要了解有关TR8 PGx的更多信息:
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.
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.
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
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脚注:
1Jarvis,JP,Peter,AP,Keogh,M.,Baldasare,V.,Beanland,GM,Wilkerson,ZT,Kradel,S.,& Shaman,JA。(2022)。药物基因组学丰富的全面药物管理计划的现实世界影响。个性化医学杂志,12(3),421。
2Jesse J Swen,Cathelijne H van der Wouden等,使用12个基因的药物基因组面板防止药物不良反应:开放标记、多中心、对照、分群随机实施研究,柳叶刀,401期,10374页,2023。247-356。
3Bain KT,Knowlton CH,Matos A。与全面护理计划相关的成本避免与药师主导的药物基因组服务。Pharmacogenomics。2020;21(10):651-661
4 Bradley P,Shiekh M,Mehra V等。使用有针对性的药物基因组指导治疗抑郁症和焦虑症的患者:一项随机临床试验,证明了临床实用性。J Psychiatr Res。2018;96:100-107。doi:10.1016/j.jpsychires.2017.09.024
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About Applied DNA Sciences
关于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.
应用DNA科学是一家正在开发生产和检测脱氧核糖核酸(“DNA”)技术的生物技术公司。我们利用聚合酶链反应(“PCR”)来实现DNA的生产和检测,从三个主要业务市场开展业务:(i)产生合成DNA的酶法制造,用于核酸为基础的治疗产品及多肽,并且通过我们最近对Spindle Biotech公司的收购提供了用于生产mRNA治疗药物的专有RNA聚合酶(“RNAP”)的开发和销售;(ii)检测分子诊断和遗传测试服务中的DNA和RNA;和(iii)供应链安全服务的制造和检测DNA。
Visit adnas.com and certaint.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.
请访问adnas.com和certaint.com以获取更多信息。在Twitter和LinkedIn上关注我们。加入我们的邮件列表。
Laboratory/Test Information
实验室/测试信息
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.
应用DNA临床实验室有限责任公司("ADCL")是纽约州公共卫生和环境实验室许可证("CLEP")允许,获得Clinical Laboratory Improvement Amendments("CLIA")证书的高复杂度检测临床实验室。 TR8检测服务是由ADCL开发的,其性能特征是由ADCL确定的。 TR8检测未获得美国食品和药物管理局的批准。 TR8检测仅用于临床目的。
Forward-Looking Statements
前瞻性声明
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.
应用DNA在本新闻稿中所发表的言论可能是“前瞻性”的,符合《1933年证券法》第27A条,证券交易法第21E条和1995年《证券诉讼改革法》。前瞻性声明描述了应用DNA的未来计划,预测,战略和期望,并基于假设并涉及许多风险和不确定因素,其中许多超出了应用DNA的控制范围。实际结果可能因其净损失历史,有限的财务资源,对PGx检测服务未来需求的未知,PGx检测服务将产生的未知收入和利润的数量,FDA继续对实验室开发的测试包括实验室开发的PGx测试行使的裁量权的未知状态以及Various其他因素时有所不同。有关这些因素的更多信息,请查看应用DNA的证券交易委员会报告和文件,包括在2023年12月7日修订的10-K年度报告以及于2024年2月8日和2024年5月10日提交的10-Q季度报告以及其他报告,该等文件可在www.sec.gov上查阅。应用DNA不承诺公开更新任何前瞻性声明以反映此后的新信息,事件或情况,除非法律另有规定。
Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com
投资者关系联系人:Sanjay M. Hurry,917-733-5573,sanjay.hurry@adnas.com
Program contact: pgx@adnas.com
Web:
Twitter: @APDN
程序联系人:pgx@adnas.com
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Twitter:@APDN
SOURCE: Applied DNA Sciences, Inc.
SOURCE: Applied DNA Sciences, Inc.