Applied DNA To Submit Application to New York State Department of Health to Expand Intended Use of Linea Mpox Virus 1.0 Assay to Mpox Clade I
Applied DNA Sciences (NASDAQ:APDN) has announced plans to expand the intended use of its Linea™ Mpox Virus 1.0 Assay to include detection of mpox Clade I, following the WHO's recent declaration of a public health emergency. The company's internal data suggests the assay can detect mpox Clade I's genetic sequence, and validation studies are underway to support a filing with the New York State Department of Health (NYSDOH).
If approved, Applied DNA could offer clinical testing services for both mpox Clade I and Clade II in its Stony Brook, N.Y. laboratory for samples from New York State and states recognizing New York's CLEP/CLIA certification. The assay is currently approved as a laboratory-developed test for mpox Clade II detection. The company emphasizes that the timing and approval of the NYSDOH filing are uncertain.
Applied DNA Sciences (NASDAQ:APDN) ha annunciato piani per espandere l'uso previsto del suo test Linea™ Mpox Virus 1.0 per includere la rilevazione del Clade I di mpox, in seguito alla recente dichiarazione dell'OMS di emergenza sanitaria pubblica. I dati interni dell'azienda suggeriscono che il test può rilevare la sequenza genetica del Clade I di mpox, e sono in corso studi di validazione per supportare una richiesta al Dipartimento della Salute dello Stato di New York (NYSDOH).
Se approvato, Applied DNA potrebbe offrire servizi di testing clinico sia per il Clade I che per il Clade II di mpox nel suo laboratorio di Stony Brook, N.Y., per campioni provenienti dallo Stato di New York e da quelli che riconoscono la certificazione CLEP/CLIA di New York. Il test è attualmente approvato come test sviluppato in laboratorio per la rilevazione del Clade II di mpox. L'azienda sottolinea che il tempismo e l'approvazione della richiesta al NYSDOH sono incerti.
Applied DNA Sciences (NASDAQ:APDN) ha anunciado planes para ampliar el uso previsto de su prueba Linea™ Mpox Virus 1.0 para incluir la detección del Clade I de mpox, tras la reciente declaración de emergencia de salud pública de la OMS. Los datos internos de la empresa sugieren que la prueba puede detectar la secuencia genética del Clade I de mpox, y se están llevando a cabo estudios de validación para respaldar una solicitud al Departamento de Salud del Estado de Nueva York (NYSDOH).
Si se aprueba, Applied DNA podría ofrecer servicios de pruebas clínicas tanto para el Clade I como para el Clade II de mpox en su laboratorio de Stony Brook, N.Y., para muestras del Estado de Nueva York y de otros estados que reconozcan la certificación CLEP/CLIA de Nueva York. La prueba está actualmente aprobada como una prueba desarrollada en laboratorio para la detección del Clade II de mpox. La empresa enfatiza que el momento y la aprobación de la solicitud al NYSDOH son inciertos.
Applied DNA Sciences (NASDAQ:APDN)은 Linea™ Mpox Virus 1.0 분석의 사용 용도를 확장할 계획을 발표했으며, 이는 WHO의 최근 공공 건강 비상 사태 선언에 따른 것입니다. 회사 내부 데이터에 따르면, 이 분석은 mpox Clade I의 유전적 서열을 감지할 수 있으며, 뉴욕주 보건부(NYSDOH)에 제출하기 위한 검증 연구가 진행 중입니다.
승인될 경우, Applied DNA는 스토니브룩, N.Y.에 위치한 실험실에서 뉴욕주 및 뉴욕의 CLEP/CLIA 인증을 인정하는 주의 샘플에 대해 mpox Clade I과 Clade II 모두에 대한 임상 검사 서비스를 제공할 수 있습니다. 현재 이 분석은 mpox Clade II 감지를 위한 실험실 개발 테스트로 승인되어 있습니다. 회사는 NYSDOH 제출의 타이밍과 승인은 불확실하다고 강조합니다.
Applied DNA Sciences (NASDAQ:APDN) a annoncé des projets pour étendre l'utilisation prévue de son test Linea™ Mpox Virus 1.0 afin d'inclure la détection du Clade I de mpox, suite à la récente déclaration d'urgence de santé publique de l'OMS. Les données internes de l'entreprise suggèrent que le test peut détecter la séquence génétique du Clade I de mpox, et des études de validation sont en cours pour soutenir une demande auprès du Département de la santé de l'État de New York (NYSDOH).
Si cela est approuvé, Applied DNA pourrait offrir des services de tests cliniques pour les Clades I et II de mpox dans son laboratoire de Stony Brook, N.Y., pour des échantillons en provenance de l'État de New York et des États reconnaissant la certification CLEP/CLIA de New York. Le test est actuellement approuvé en tant que test développé en laboratoire pour la détection du Clade II de mpox. L'entreprise souligne que le calendrier et l'approbation du dépôt auprès du NYSDOH sont incertains.
Applied DNA Sciences (NASDAQ:APDN) hat Pläne angekündigt, um die beabsichtigte Verwendung seines Linea™ Mpox Virus 1.0 Tests zu erweitern, um die Erkennung des mpox Clade I einzuschließen, nachdem die WHO kürzlich einen öffentlichen Gesundheitsnotstand erklärt hat. Die internen Daten des Unternehmens deuten darauf hin, dass der Test die genetische Sequenz des mpox Clade I nachweisen kann, und Validierungsstudien sind im Gange, um einen Antrag beim Gesundheitsministerium des Bundesstaates New York (NYSDOH) zu unterstützen.
Wenn genehmigt, könnte Applied DNA klinische Testdienstleistungen sowohl für mpox Clade I als auch Clade II in seinem Labor in Stony Brook, N.Y., für Proben aus dem Bundesstaat New York und aus Staaten anbieten, die die CLEP/CLIA-Zertifizierung New Yorks anerkennen. Der Test ist derzeit als ein im Labor entwickelter Test zur Erkennung von mpox Clade II genehmigt. Das Unternehmen betont, dass der Zeitpunkt und die Genehmigung des Antrags beim NYSDOH ungewiss sind.
- Potential expansion of Linea™ Mpox Virus 1.0 Assay to detect mpox Clade I
- Internal data shows assay can detect mpox Clade I genetic sequence
- Possible increase in testing services if approved for both Clade I and II
- Uncertain timing and approval of NYSDOH filing
- to samples from New York State and states recognizing New York's certification
Insights
Applied DNA's move to expand its Linea™ Mpox Virus 1.0 Assay to detect Clade I is a timely response to the WHO's recent PHEIC declaration. This expansion could potentially position the company as a key player in addressing the evolving mpox threat. However, investors should note that approval is not guaranteed and the timeline remains uncertain. The company's ability to detect both Clade I and II could enhance its market position, especially given the number of approved tests for mpox. This development demonstrates Applied DNA's agility in adapting to public health needs, which could be viewed favorably by stakeholders in the medical diagnostics sector.
While the potential expansion of Applied DNA's mpox assay is promising, its financial impact remains speculative. The company's proactive approach could lead to increased testing revenues if approved, particularly given the recent WHO declaration. However, investors should consider that the diagnostic market is highly competitive and the demand for mpox testing may fluctuate based on outbreak severity. The
The global mpox diagnostics market is projected to grow significantly, driven by increased awareness and testing needs. Applied DNA's move to expand its assay capabilities aligns with market trends and could strengthen its competitive position. However, the market dynamics are complex. Factors such as government funding, public health policies and competing diagnostic technologies will influence adoption rates. The company's focus on both Clade I and II detection could provide a unique selling point, potentially capturing market share from less comprehensive tests. Investors should monitor global mpox case trends and regulatory approvals to assess the long-term market potential for Applied DNA's expanded assay.
STONY BROOK, NY / ACCESSWIRE / August 19, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, today announced its intention to seek an expansion of the approved intended use of its Linea™ Mpox Virus 1.0 Assay (the "Assay") to include the detection of mpox Clade I that is the subject of the World Health Organization's (WHO) 14 August 2024 declaration of a public health emergency of international concern (PHEIC). The Company's internally generated data show that the Assay can detect the genetic sequence of mpox Clade I and is now undertaking validation studies to enable the filing of necessary documentation with the New York State Department of Health (NYSDOH). The Company plans to make its NYSDOH filing as soon as practicable based on the turnaround times for necessary reagents and control materials. No assurance can be given regarding the timing of any NYSDOH approval and whether such approval will ever be granted.
The Assay was approved as a laboratory-developed test for the detection of mpox Clade II (previously monkeypox) 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.
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 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.
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. Further, the uncertainties inherent in research and development, future data and analysis, including whether Linea Mpox Virus 1.0 Assay will, if ever, be validated for the detection of mpox Clade I in clinical samples or 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.
Contacts:
Applied DNA Sciences
Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com
Web: www.adnas.com
Twitter: @APDN
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SOURCE: Applied DNA Sciences, Inc.
View the original press release on accesswire.com
FAQ
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