Aspira Women’s Health Receives Approval from New York State Department of Health for OvaWatch®
Aspira Women's Health Inc. (Nasdaq: AWH) has received approval from the New York State Department of Health's (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) for OvaWatch®. This non-invasive blood test assesses ovarian cancer risk in women with adnexal masses initially determined as indeterminate or benign. The CLEP approval, required for all lab-developed tests in New York, ensures compliance with state regulatory standards and includes a comprehensive review of Quality Management Systems.
CEO Nicole Sandford highlighted the significance of this approval, stating it opens doors to one of the nation's largest healthcare markets with over 10 million women in New York state. The CLEP approval is viewed as a validation of the test's rigorous science, potentially strengthening Aspira's credibility in other markets and positioning the company well for future regulatory pathways.
Aspira Women's Health Inc. (Nasdaq: AWH) ha ricevuto l'approvazione dal Programma di Valutazione dei Laboratori Clinici (CLEP) del Dipartimento della Salute dello Stato di New York (NYSDOH) per OvaWatch®. Questo test del sangue non invasivo valuta il rischio di cancro ovarico nelle donne con masse adnexali inizialmente determinate come indeterminate o benigne. L'approvazione del CLEP, necessaria per tutti i test sviluppati in laboratorio a New York, garantisce la conformità agli standard normativi statali e include una revisione completa dei Sistemi di Gestione della Qualità.
Il CEO Nicole Sandford ha sottolineato l'importanza di questa approvazione, affermando che apre le porte a uno dei più grandi mercati sanitari della nazione con oltre 10 milioni di donne nello stato di New York. L'approvazione del CLEP è vista come una validazione della rigorosa scienza del test, potenzialmente rafforzando la credibilità di Aspira in altri mercati e posizionando bene l'azienda per futuri percorsi normativi.
Aspira Women's Health Inc. (Nasdaq: AWH) ha recibido la aprobación del Programa de Evaluación de Laboratorios Clínicos (CLEP) del Departamento de Salud del Estado de Nueva York (NYSDOH) para OvaWatch®. Esta prueba de sangre no invasiva evalúa el riesgo de cáncer de ovario en mujeres con masas adnexales inicialmente determinadas como indeterminadas o benignas. La aprobación del CLEP, necesaria para todas las pruebas desarrolladas en laboratorio en Nueva York, garantiza la conformidad con los estándares regulatorios estatales e incluye una revisión completa de los Sistemas de Gestión de Calidad.
La CEO Nicole Sandford destacó la importancia de esta aprobación, afirmando que abre las puertas a uno de los mercados de salud más grandes del país, con más de 10 millones de mujeres en el estado de Nueva York. La aprobación del CLEP se considera una validación de la rigurosa ciencia de la prueba, lo que podría fortalecer la credibilidad de Aspira en otros mercados y posicionar a la empresa de manera favorable para futuros caminos regulatorios.
Aspira Women's Health Inc. (Nasdaq: AWH)는 뉴욕주 보건부(NYSDOH)의 임상 실험실 평가 프로그램(CLEP)으로부터 OvaWatch®에 대한 승인을 받았습니다. 이 비침습적인 혈액 검사는 애드넥스 질량이 처음에 불확실하거나 양성으로 판단된 여성의 난소암 위험을 평가합니다. CLEP 승인은 뉴욕의 모든 실험실 개발 테스트에 필요하며 주 규제 기준 준수를 보장하고 품질 관리 시스템에 대한 포괄적인 검토를 포함합니다.
CEO 니콜 샌드포드는 이 승인의 중요성을 강조하며, 이는 뉴욕주에 1천만 명이 넘는 여성들이 있는 미국 최대의 의료 시장 중 하나로 진입할 수 있는 기회를 열어준다고 말했습니다. CLEP 승인은 이 테스트의 엄격한 과학에 대한 검증으로 여겨지며, Aspira의 다른 시장에서의 신뢰성을 강화하고 미래의 규제 경로를 위해 회사를 잘 포지셔닝할 가능성이 있습니다.
Aspira Women's Health Inc. (Nasdaq: AWH) a reçu l'approbation du Programme d'Évaluation des Laboratoires Cliniques (CLEP) du Département de la Santé de l'État de New York (NYSDOH) pour OvaWatch®. Ce test sanguin non invasif évalue le risque de cancer de l'ovaire chez les femmes présentant des masses annexielles initialement déterminées comme indéterminées ou bénignes. L'approbation du CLEP, requise pour tous les tests développés en laboratoire à New York, garantit la conformité aux normes réglementaires de l'État et comprend un examen complet des Systèmes de Gestion de la Qualité.
Le PDG Nicole Sandford a souligné l'importance de cette approbation, déclarant qu'elle ouvre des portes à l'un des plus grands marchés de la santé du pays, avec plus de 10 millions de femmes dans l'État de New York. L'approbation du CLEP est considérée comme une validation de la science rigoureuse du test, ce qui pourrait renforcer la crédibilité d'Aspira sur d'autres marchés et positionner l'entreprise favorablement pour de futurs parcours réglementaires.
Aspira Women's Health Inc. (Nasdaq: AWH) hat die Genehmigung des Clinical Laboratory Evaluation Program (CLEP) des Gesundheitsministeriums des Bundesstaates New York (NYSDOH) für OvaWatch® erhalten. Dieser nicht-invasive Bluttest bewertet das Risiko von Eierstockkrebs bei Frauen mit zunächst als unbestimmt oder gutartig eingestuften Adnexmasse. Die CLEP-Genehmigung, die für alle im Labor entwickelten Tests in New York erforderlich ist, gewährleistet die Einhaltung der staatlichen regulatorischen Standards und umfasst eine umfassende Überprüfung der Qualitätsmanagementsysteme.
Die CEO Nicole Sandford hob die Bedeutung dieser Genehmigung hervor und erklärte, sie öffne die Türen zu einem der größten Gesundheitsmärkte des Landes mit über 10 Millionen Frauen im Bundesstaat New York. Die CLEP-Genehmigung wird als Validierung der strengen Wissenschaft des Tests angesehen, was potenziell die Glaubwürdigkeit von Aspira auf anderen Märkten stärken und das Unternehmen gut für zukünftige regulatorische Wege positionieren könnte.
- Received NYSDOH CLEP approval for OvaWatch®
- Gained access to New York's market of over 10 million women
- CLEP approval potentially strengthens credibility in other markets
- Positions company well for future regulatory pathways
- None.
Insights
The approval of OvaWatch® by the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) is a significant milestone for Aspira Women's Health. This non-invasive blood test for assessing ovarian cancer risk in women with adnexal masses could potentially reduce unnecessary surgeries and improve patient outcomes.
The CLEP approval process is known for its stringency, often considered comparable to or even more rigorous than some federal regulatory pathways. This endorsement not only allows Aspira to market OvaWatch® in New York State but also enhances the test's credibility nationwide. It validates the scientific rigor behind the test and may facilitate future regulatory approvals.
For investors, this development opens up a substantial market opportunity. New York State, with over 10 million women, represents a significant potential customer base. Moreover, the CLEP approval could accelerate adoption in other states and potentially lead to increased revenue streams for Aspira.
However, it's important to note that while this approval is a positive step, the company still faces challenges in market penetration, physician adoption and competition from other diagnostic tools. Investors should monitor how quickly Aspira can capitalize on this opportunity and translate it into tangible financial results.
The NYSDOH CLEP approval for OvaWatch® is a strategic win for Aspira Women's Health, potentially catalyzing both short-term and long-term growth. In the immediate future, this opens up the New York market, which is not only large in terms of population but also influential in healthcare trends.
From a market perspective, this approval addresses several key factors:
- Market Access: Immediate entry into a major healthcare market.
- Credibility Boost: CLEP approval enhances the test's reputation nationwide.
- Competitive Advantage: Positions Aspira ahead of competitors without this specific approval.
- Scalability: Sets a precedent for easier entry into other stringent markets.
The non-invasive nature of OvaWatch® aligns with the growing trend towards less invasive diagnostic tools, which could drive adoption among both physicians and patients. However, the company will need to invest in marketing and education to ensure rapid uptake.
Investors should watch for partnerships with healthcare providers in New York, expansion plans for other states and any impact on Aspira's revenue projections in upcoming financial reports.
New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation (CLEP) approval allows for OvaWatch® to be marketed in New York State
AUSTIN, Texas, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools, today announced that it has received approval from the New York State Department of Health’s (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) for OvaWatch®, the Company’s non-invasive blood test for the assessment of ovarian cancer risk for women with an adnexal mass determined by initial clinical assessment as indeterminate or benign, and thus surgery may be premature or unnecessary.
NYSDOH/CLEP approval is required for all lab developed tests to ensure compliance with New York State’s clinical laboratory regulatory standards. The comprehensive review process includes an assessment of Quality Management Systems to ensure robust procedures for maintaining quality, traceability, and risk management.
“We are gratified to have secured CLEP approval for OvaWatch opening the door to one of the nation's largest healthcare markets with over 10 million women residing in New York state,” said Nicole Sandford, CEO of Aspira Women’s Health. “Additionally, with a process that some view as equal to or more stringent than some at the Federal level, we believe that CLEP approval provides important validation of the rigorous science behind our test, strengthens our credibility in other markets, and positions us well for other regulatory pathways. I am very proud of our team and this accomplishment, and we look forward to bringing this test to the millions of women in New York state.”
About OvaWatch®
OvaWatch is the only non-invasive blood test available to assess the risk of ovarian cancer in patients with an adnexal mass initially evaluated as indeterminate or benign. With a
About Aspira Women’s Health Inc.
Aspira Women’s Health Inc. is dedicated to the discovery, development, and commercialization of noninvasive, AI-powered tests to aid in the diagnosis of gynecologic diseases.
OvaWatch® and Ova1Plus® are offered to clinicians as OvaSuite℠. Together, they provide the only comprehensive portfolio of blood tests to aid in the detection of ovarian cancer risk for the 1.2+ million American women diagnosed with an adnexal mass each year. OvaWatch provides a negative predictive value of
Our in-development test pipeline is designed to expand our ovarian cancer portfolio and addresses the tremendous need for noninvasive diagnostics for endometriosis, a debilitating disease that impacts millions of women worldwide. In ovarian cancer, our OvaMDx risk assessment is designed to combine microRNA and protein biomarkers with patient data to further enhance the sensitivity and specificity of our current tests. In endometriosis, EndoCheck℠ is the first-ever noninvasive test designed to identify endometriomas, one of the most commonly occurring forms of endometriosis. Aspira’s other in-development endometriosis test is designed to combine microRNA and protein biomarkers with patient data to identify all endometriosis.
Forward-Looking Statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve a number of risks and uncertainties. Such forward-looking statements include statements regarding, among other things, the timing and completion of any products in the pipeline development and other statements that are predictive in nature. Actual results could differ materially from those discussed due to known and unknown risks, uncertainties, and other factors. These forward-looking statements generally can be identified by the use of words such as “designed to,” “expect,” “plan,” “anticipate,” “could,” “may,” “intend,” “will,” “continue,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this press release and other factors that may cause such differences include the satisfaction of customary closing conditions related to the offering and the expected timing of the closing of the offering. These and additional risks and uncertainties are described more fully in the company’s filings with the SEC, including those factors identified as “Risk Factors” in our most recent Annual Report on Form 10-K, for the fiscal year ended December 31, 2023, and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Aspira presently does not know, or that Aspira currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Aspira’s expectations, plans, or forecasts of future events and views as of the date of this press release. Subsequent events and developments may cause the Company’s assessments to change. However, while Aspira may elect to update these forward-looking statements at some point in the future, Aspira expressly disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Aspira’s assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.
Investor Relations Contact:
Monique Kosse
Investor Relations Specialist
Investors@aspirawh.com
FAQ
What is OvaWatch® and what did Aspira Women's Health (AWH) receive approval for?
Why is the NYSDOH CLEP approval important for Aspira Women's Health (AWH)?
What does the NYSDOH CLEP approval process involve for Aspira Women's Health's OvaWatch®?
How might the NYSDOH CLEP approval impact Aspira Women's Health's (AWH) future prospects?
