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.
應用DNA科技公司（NASDAQ：APDN）是PCR基因檢測技術領導者，今天宣佈紐約州衛生部（NYSDOH）批准了該公司的TR8 PGx （"TR8"）藥物基因檢測服務。公司正在與企業客戶，醫療網絡和私人醫生合作進行大規模檢測。這些機構和醫生都希望在檢測菜單中增加PGx檢測。
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.
應用DNA的臨床實驗室子公司，應用DNA臨床實驗室有限責任公司（ADCL）正在推出其PGx檢測服務，幫助醫療保健提供者根據病人的獨特基因來使用治療心血管，腫瘤，精神疾病，傳染病和疼痛管理的各種藥物。該服務僅限處方，最初將以紐約州病人爲目標。
"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."
“紐約州的標準是全國最嚴格的之一。我們的TR8檢測服務獲得批准，標誌着公司取得了重要的監管里程碑。我們認爲，紐約州是PGx檢測的可持續市場，我們正在積極與企業，醫療系統和大型企業合作，以確立市場份額，” 應用DNA公司總裁兼首席執行官詹姆斯·A·海沃德博士表示。“推出這項檢測服務是我們爲推進個性化醫療而承諾通過成本效益和可擴展的基因檢測來改善患者治療結果和降低醫療成本。我們很高興爲紐約人帶來PGx檢測，我們相信這將極大潛力幫助他們享受健康的人生。”
TR8 PGx - Enterprise-scale Pharmacogenomic Testing
TR8 PGx - 企業級藥物基因檢測
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檢測分析30多個基因中的120個遺傳靶點，以告知醫療保健提供者病人可能對多種治療心血管，腫瘤，精神疾病和疼痛管理的藥物的反應。這項檢測通過簡單的唾液DNA檢測進行。
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.
通過得到有關病人基於基因組的藥物反應的信息，醫療保健提供者可以在選擇處方藥物時作出更好的決策，從而優化醫療質量和功效。研究表明，在企業級應用中部署PGx檢測，如醫療系統，機構和自負一部分企業，即美國所有僱主的約65％，可以降低機構保健成本，改善人群健康和提高生產力。1,2,3,4關於美國所有僱主在2023年佔比約65％。5.
To learn more about TR8 PGx:
要了解有關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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腳註：
1Jarvis，JP，Peter，AP，Keogh，M.，Baldasare，V.，Beanland，GM，Wilkerson，ZT，Kradel，S.，& Shaman，JA。（2022）。藥物基因組學豐富的全面藥物管理計劃的現實世界影響。個性化醫學雜誌，12（3），421。
2Jesse J Swen，Cathelijne H van der Wouden等，使用12個基因的藥物基因組面板防止藥物不良反應：開放標記、多中心、對照、分群隨機實施研究，柳葉刀，401期，10374頁，2023。247-356。
3Bain KT，Knowlton CH，Matos A。與全面護理計劃相關的成本避免與藥師主導的藥物基因組服務。Pharmacogenomics。2020;21（10）：651-661
4 Bradley P，Shiekh M，Mehra V等。使用有針對性的藥物基因組指導治療抑鬱症和焦慮症的患者：一項隨機臨床試驗，證明了臨床實用性。J Psychiatr Res。2018;96：100-107。doi：10.1016/j.jpsychires.2017.09.024
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About Applied DNA Sciences
關於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.
應用DNA科學是一家正在開發生產和檢測脫氧核糖核酸（“DNA”）技術的生物技術公司。我們利用聚合酶鏈反應（“PCR”）來實現DNA的生產和檢測，從三個主要業務市場開展業務：（i）產生合成DNA的酶法制造，用於核酸爲基礎的治療產品及多肽，並且通過我們最近對Spindle Biotech公司的收購提供了用於生產mRNA治療藥物的專有RNA聚合酶（“RNAP”）的開發和銷售;（ii）檢測分子診斷和遺傳測試服務中的DNA和RNA;和（iii）供應鏈安全服務的製造和檢測DNA。
Visit adnas.com and certaint.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.
請訪問adnas.com和certaint.com以獲取更多信息。在Twitter和LinkedIn上關注我們。加入我們的郵件列表。
Laboratory/Test Information
實驗室/測試信息
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.
應用DNA臨床實驗室有限責任公司（"ADCL"）是紐約州公共衛生和環境實驗室許可證（"CLEP"）允許，獲得Clinical Laboratory Improvement Amendments（"CLIA"）證書的高複雜度檢測臨床實驗室。 TR8檢測服務是由ADCL開發的，其性能特徵是由ADCL確定的。 TR8檢測未獲得美國食品和藥物管理局的批准。 TR8檢測僅用於臨床目的。
Forward-Looking Statements
前瞻性聲明
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.
應用DNA在本新聞稿中所發表的言論可能是“前瞻性”的，符合《1933年證券法》第27A條，證券交易法第21E條和1995年《證券訴訟改革法》。前瞻性聲明描述了應用DNA的未來計劃，預測，戰略和期望，並基於假設並涉及許多風險和不確定因素，其中許多超出了應用DNA的控制範圍。實際結果可能因其淨損失歷史，有限的財務資源，對PGx檢測服務未來需求的未知，PGx檢測服務將產生的未知收入和利潤的數量，FDA繼續對實驗室開發的測試包括實驗室開發的PGx測試行使的裁量權的未知狀態以及Various其他因素時有所不同。有關這些因素的更多信息，請查看應用DNA的證券交易委員會報告和文件，包括在2023年12月7日修訂的10-K年度報告以及於2024年2月8日和2024年5月10日提交的10-Q季度報告以及其他報告，該等文件可在www.sec.gov上查閱。應用DNA不承諾公開更新任何前瞻性聲明以反映此後的新信息，事件或情況，除非法律另有規定。
Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com
投資者關係聯繫人：Sanjay M. Hurry，917-733-5573，sanjay.hurry@adnas.com
Program contact: pgx@adnas.com
Web:
Twitter: @APDN
程序聯繫人：pgx@adnas.com
網站：
Twitter：@APDN
SOURCE: Applied DNA Sciences, Inc.
SOURCE: Applied DNA Sciences, Inc.
譯文內容由第三人軟體翻譯。