Applied DNA Submits Validation Package to New York State Department of Health to Expand Linea Mpox Virus 1.0 Assay to Mpox Clade I
Applied DNA Submits Validation Package to New York State Department of Health to Expand Linea Mpox Virus 1.0 Assay to Mpox Clade I
The Assay was previously approved as a laboratory-developed test for the detection of mpox clade II by NYSDOH in September 2022. If approved for the testing of clade I, the Company could provide clinical testing services in its CLEP/CLIA molecular diagnostics laboratory in Stony Brook, N.Y. for mpox clade I and clade II on samples originating in New York State and in states that recognize New York's CLEP/CLIA certification for testing.-Validation Studies Confirmed the Assay Can Detect Mpox Clade I and Clade Ib in addition to Clade II-
-驗證研究確認該檢測方法不僅可以檢測MPOX I類和Ib類，還可以檢測到II類-
STONY BROOK, NY / ACCESSWIRE / August 23, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (the "Company"), a leader in PCR-based DNA technologies, today announced 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 an expansion of the permitted use of its Linea Mpox Virus 1.0 Assay (the "Assay") to include both mpox clade I and clade II. The Company's validation studies concluded that the Assay's primers and probe have 100% homology to mpox clade I and clade Ib, the latter of which was the subject of the World Health Organization's (WHO) recently declared public health emergency of international concern.
美國紐約州石溪/ ACCESSWIRE/2024年8月23日/ 生物技術公司Applied DNA Sciences，Inc.(納斯達克代碼:APDN)(以下簡稱"本公司")是PCR基因技術領域的領導者, 今天宣佈其全資子公司Applied DNA Clinical Labs, LLC(ADCL)已向紐約州衛生部(NYSDOH)提交了一個驗證文檔，以支持將其Linea Mpox Virus 1.0 Assay(下稱"Assay")的使用範圍擴大到MPOX I類和II類。本公司的驗證研究結果顯示，Assay的引物和探針與MPOX I類和Ib類有100%的同源性，後者是世界衛生組織(WHO)最近宣佈的國際關注的公共衛生緊急情況的主題。
The timeline for NYSDOH's review of the Company's validation package is not currently known and there can be no assurances that NYSDOH will approve the Company's requested expansion of the Assay to clade I.
目前，紐約州衛生部對本公司的驗證文件進行審查的時間尚不明確，無法保證紐約州衛生部將批准本公司將該檢測方法擴展到I類。
The Assay was previously approved as a laboratory-developed test for the detection of mpox clade II by NYSDOH in September 2022. If approved for the testing of clade I, the Company could provide clinical testing services in its CLEP/CLIA molecular diagnostics laboratory in Stony Brook, N.Y. for mpox clade I and clade II on samples originating in New York State and in states that recognize New York's CLEP/CLIA certification for testing.
Assay於2022年9月獲得紐約州衛生部批准，作爲一種用於檢測MPOX II類的實驗室開發測試。如果獲得I類的測試批准，本公司可以在其位於紐約州石溪的CLEP/CLIA分子診斷實驗室中提供MPOX I類和II類的臨床檢測服務，以及紐約州及承認紐約CLEP/CLIA認證測試的州份的樣本。
Laboratory/Test Information
實驗室/測試信息
ADCL is a NYSDOH CLEP-permitted, Clinical Laboratory Improvement Amendments ("CLIA")-certified clinical laboratory, certified to perform high-complexity testing. The Linea Mpox Virus 1.0 Assay was developed, and its performance characteristics were determined by ADCL. The Linea Mpox Virus 1.0 Assay has not been cleared or approved by the U.S. Food and Drug Administration. The Linea Mpox Virus 1.0 Assay is intended for clinical purposes.
ADCL是紐約州衛生部CLEP許可的、Clinical Laboratory Improvement Amendments (CLIA)認證的臨床實驗室，具備高複雜性檢測資質。Linea Mpox Virus 1.0 Assay是由ADCL開發並確定了其性能特徵。Linea Mpox Virus 1.0 Assay尚未獲得美國食品藥品監督管理局（FDA）的清除或批准。Linea Mpox Virus 1.0 Assay是用於臨床目的。
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 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.
Applied DNA Sciences是一家生物技術公司，開發生產和檢測脫氧核糖核酸（"DNA"）的技術。我們使用聚合酶鏈式反應（"PCR"）來實現DNA的生產和檢測，主要在三個業務市場運營：（i）用於生產核酸基治療藥物的合成DNA的酶製造和銷售以及用於生產mRNA治療藥物的專有RNA聚合酶（"RNAP"）的開發和銷售；（ii）分子診斷和遺傳測試服務中的DNA和RNA的檢測；以及（iii）用於工業供應鏈安全服務的DNA的製造和檢測。
Visit adnas.com for more information. Follow us on X and LinkedIn. Join our mailing list.
請訪問adnas.com了解更多信息。關注我們的X和領英。加入我們的郵件列表。
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. Further, the uncertainties inherent in research and development, future data and analysis, including whether the Linea Mpox Virus 1.0 Assay will, if ever, receive approval from NYSDOH for the detection of mpox clade I in clinical samples, and/or disruptions in the supply of raw materials and supplies. In addition, actual results could differ materially from those projected due to the Company's history of net losses, the unknown demand, revenue and profits, if any, that will result from mpox testing, limited financial resources, 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, May 10, 2024, and August 8, 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.
Applied DNA在本新聞稿中所做的聲明可能屬於"前瞻性"，根據1933年證券法第27A條、1934年證券交易法第21E條和1995年私人證券訴訟改革法。前瞻性陳述描述了Applied DNA的未來計劃、預測、策略和期望，並基於一些假設並涉及多個風險和不確定性，其中很多是Applied DNA無法控制的。此外，研發、未來數據和分析中的不確定性，包括Linea Mpox Virus 1.0 Assay是否會在臨床樣本中檢測到mpox clade I並獲得NYSDOH的批准，以及原材料和供應的中斷。此外，由於公司的淨虧損歷史、未知的需求、收入和利潤（如果有的話）以及有限的財務資源，實際結果可能與預期有很大的差距，這些細節不時在Applied DNA的SEC報告和申報中詳細描述，其中包括其於2023年12月7日修訂後提交的年度報告Form 10-k以及在2024年2月8日、5月10日和8月8日提交的季度報告Form 10-Q，以及其他提交給SEC的報告，可以在www.sec.gov上找到。Applied DNA沒有義務在此之後公開更新任何前瞻性陳述以反映新信息、事件或情況，除非法律另有要求。
Corporate Contacts:
公司聯繫信息：
Investor Relations Contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com
Web:
Twitter: @APDN
投資者關係聯繫人：Sanjay m. Hurry，917-733-5573，sanjay.hurry@adnas.com
網站：
Twitter：@APDN
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SOURCE: Applied DNA Sciences
來源：applied dna sciences
譯文內容由第三人軟體翻譯。
