Applied DNA Launches Mpox Clade I and Clade II Testing Service
Applied DNA Sciences (NASDAQ:APDN) has announced the expansion of its clinical testing services for Mpox (formerly monkeypox) to include both Clade I and Clade II detection. This launch follows interactions with regulatory bodies, including the New York State Department of Health (NYSDOH) and the FDA. The company's subsidiary, Applied DNA Clinical Labs (ADCL), will provide the testing service from its CLEP/CLIA molecular diagnostics laboratory in Stony Brook, N.Y.
The Linea™ Mpox Virus 1.0 Assay was previously approved for Clade II detection by NYSDOH in September 2022. In August 2024, ADCL validated the assay's ability to detect Clade I, which is the subject of the WHO's recent public health emergency declaration. This expanded testing service aims to support New York and other states in responding to the growing mpox threat by improving testing accessibility.
Applied DNA Sciences (NASDAQ:APDN) ha annunciato l'espansione dei suoi servizi di test clinici per Mpox (precedentemente noto come monkeypox) per includere la rilevazione di Clade I e Clade II. Questo lancio segue le interazioni con gli organismi di regolamentazione, inclusi il Dipartimento della Salute dello Stato di New York (NYSDOH) e la FDA. La sussidiaria dell'azienda, Applied DNA Clinical Labs (ADCL), fornirà il servizio di test dal suo laboratorio di diagnostica molecolare CLEP/CLIA a Stony Brook, N.Y.
Il Linea™ Mpox Virus 1.0 Assay è stato precedentemente approvato per la rilevazione di Clade II dal NYSDOH nel settembre 2022. Nell'agosto 2024, ADCL ha convalidato la capacità dell'assay di rilevare Clade I, che è oggetto della recentè dichiarazione di emergenza sanitaria pubblica dell'OMS. Questo servizio di test ampliato mira a supportare New York e altri stati nella risposta alla crescente minaccia di mpox migliorando l'accessibilità ai test.
Applied DNA Sciences (NASDAQ:APDN) ha anunciado la expansión de sus servicios de pruebas clínicas para Mpox (anteriormente conocido como viruela de los simios) para incluir la detección de Clade I y Clade II. Este lanzamiento sigue interacciones con organismos reguladores, incluidos el Departamento de Salud del Estado de Nueva York (NYSDOH) y la FDA. La subsidiaria de la empresa, Applied DNA Clinical Labs (ADCL), proporcionará el servicio de pruebas desde su laboratorio de diagnóstico molecular CLEP/CLIA en Stony Brook, N.Y.
El Linea™ Mpox Virus 1.0 Assay fue aprobado anteriormente para la detección de Clade II por el NYSDOH en septiembre de 2022. En agosto de 2024, ADCL validó la capacidad del ensayo para detectar Clade I, que es objeto de la reciente declaración de emergencia de salud pública de la OMS. Este servicio de pruebas ampliado tiene como objetivo apoyar a Nueva York y otros estados en la respuesta a la creciente amenaza de mpox mejorando la accesibilidad a las pruebas.
Applied DNA Sciences (NASDAQ:APDN)는 Mpox (이전의 원숭이 수두)에 대한 임상 테스트 서비스의 확대를 발표하였습니다. Clade I 및 Clade II 검출을 포함하게 됩니다. 이러한 출범은 뉴욕주 보건부 (NYSDOH) 및 FDA와의 규제 기관과의 상호작용 후 이뤄졌습니다. 회사의 자회사인 Applied DNA Clinical Labs (ADCL)는 뉴욕주 스토니 브룩의 CLEP/CLIA 분자 진단 실험실에서 이 테스트 서비스를 제공할 예정입니다.
Linea™ Mpox Virus 1.0 Assay는 2022년 9월 NYSDOH에 의해 Clade II 검출을 위해 이전에 승인되었습니다. 2024년 8월, ADCL은 WHO의 최근 공공 건강 비상 사태 선언의 주제인 Clade I을 검출할 수 있는 능력을 검증하였습니다. 이 확장된 테스트 서비스는 증가하는 mpox 위협에 대응하기 위해 뉴욕과 다른 주에서 테스트 접근성을 향상시키는 것을 목표로 하고 있습니다.
Applied DNA Sciences (NASDAQ:APDN) a annoncé l'expansion de ses services de test clinique pour le Mpox (anciennement la variole des singes), afin d'inclure la détection des Clade I et Clade II. Ce lancement fait suite à des interactions avec des organismes de réglementation, notamment le Département de la santé de l'État de New York (NYSDOH) et la FDA. La filiale de l'entreprise, Applied DNA Clinical Labs (ADCL), fournira le service de test depuis son laboratoire de diagnostic moléculaire CLEP/CLIA à Stony Brook, N.Y.
Le Linea™ Mpox Virus 1.0 Assay a été précédemment approuvé pour la détection de Clade II par le NYSDOH en septembre 2022. En août 2024, ADCL a validé la capacité de l'essai à détecter Clade I, qui fait l'objet de la récente déclaration d'urgence de santé publique de l'OMS. Ce service de test élargi vise à soutenir New York et d'autres États dans leur réponse à la menace croissante de mpox en améliorant l'accessibilité des tests.
Applied DNA Sciences (NASDAQ:APDN) hat die Erweiterung seiner klinischen Testdienste für Mpox (vormals Affenpocken) bekannt gegeben, um die Erkennung von Clade I und Clade II einzuschließen. Dieser Start folgt Interaktionen mit Aufsichtsbehörden, einschließlich des Gesundheitsministeriums des Bundesstaates New York (NYSDOH) und der FDA. Die Tochtergesellschaft des Unternehmens, Applied DNA Clinical Labs (ADCL), wird den Testdienst aus ihrem molekularen Diagnoselabor CLEP/CLIA in Stony Brook, N.Y., bereitstellen.
Der Linea™ Mpox Virus 1.0 Assay wurde zuvor im September 2022 vom NYSDOH für die Erkennung von Clade II genehmigt. Im August 2024 validierte ADCL die Fähigkeit des Tests zur Erkennung von Clade I, was Gegenstand der jüngsten Erklärung des WHO über den öffentlichen Gesundheitsnotstand ist. Dieser erweiterte Testdienst zielt darauf ab, New York und anderen Bundesstaaten bei der Reaktion auf die wachsende Bedrohung durch Mpox zu unterstützen, indem die Zugänglichkeit der Tests verbessert wird.
- Expansion of Mpox testing services to include both Clade I and Clade II detection
- Approval from NYSDOH for the Linea™ Mpox Virus 1.0 Assay
- Validation of the assay's ability to detect Clade I, addressing the recent WHO public health emergency declaration
- Potential to support state responses to the growing mpox threat
- The Linea Mpox Virus 1.0 Assay has not been cleared or approved by the FDA
The launch of Applied DNA's expanded mpox testing service is a significant development in the field of infectious disease diagnostics. The ability to detect both Clade I and Clade II of the mpox virus enhances the diagnostic capabilities for healthcare providers. This is particularly important given the WHO's recent declaration of a public health emergency concerning Clade I.
The regulatory interactions with NYSDOH and FDA suggest a thorough validation process, which adds credibility to the test. However, it's important to note that while NYSDOH-approved, the test is not yet FDA-cleared. This could potentially limit its widespread adoption outside New York State in the short term.
From an investor's perspective, this expansion could position Applied DNA favorably in the infectious disease testing market, potentially leading to increased revenue streams. However, the actual impact will depend on the prevalence of mpox cases and the demand for such testing services.
Applied DNA's strategic move to expand its mpox testing capabilities comes at a crucial time in the infectious disease diagnostics market. With the WHO's recent declaration, there's likely to be increased demand for comprehensive mpox testing, potentially driving growth for Applied DNA.
The company's first-mover advantage in offering testing for both Clade I and II could give it a competitive edge. However, investors should be aware that the market size for mpox testing remains uncertain and could fluctuate based on outbreak patterns.
The company's ability to rapidly adapt its existing assay to detect a new clade demonstrates its technological agility, which could be valuable for future product developments. This could enhance Applied DNA's appeal to investors looking for companies with flexible and responsive R&D capabilities in the biotech sector.
STONY BROOK, NY / ACCESSWIRE / September 11, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, today announced that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has launched an expansion of its clinical testing services for the detection of Mpox (formerly monkeypox) to include testing for both mpox Clade I and Clade II. The launch of the expanded mpox testing service comes after ADCL's interaction with relevant regulatory bodies, including the New York State Department of Health (NYSDOH) and the U.S. Food and Drug Administration (FDA).
"With the launch of the expanded testing services, we believe ADCL is poised to support New York and other states' response to the growing threat of mpox by improving accessibility to testing to equip clinicians with the necessary tools to diagnose and mitigate the virus's spread," stated Dr. James A. Hayward, president and CEO of Applied DNA.
ADCL's Linea™ Mpox Virus 1.0 Assay was previously approved as a laboratory-developed test for the detection of mpox clade II by NYSDOH in September 2022. In August 2024, ADCL conducted additional validation testing showing the Assay can also detect the genetic sequence of mpox Clade I, which is the subject of the World Health Organization's (WHO) 14 August 2024 declaration of a public health emergency of international concern. ADCL will provide the testing service from its CLEP/CLIA molecular diagnostics laboratory in Stony Brook, N.Y.
Laboratory/Test Information
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 FDA. The Linea Mpox Virus 1.0 Assay is intended for clinical purposes.
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 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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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. In addition, actual results could differ materially from those projected due to the Company's history of net losses and limited financial resources, the unknown demand, revenue and profits, if any, that will result from mpox testing, disruptions in the supply of raw materials and supplies, future changes in the regulatory status of the Linea™ Mpox Virus 1.0 Assay, unknown mpox infection rates in the United States, 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 Reports 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.
Corporate Contacts:
Investor Relations Contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com
Web: www.adnas.com
X: @APDN
SOURCE: Applied DNA Sciences, Inc.
View the original press release on accesswire.com
FAQ
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