Aspira Women’s Health Announces Publication of Data Demonstrating Performance of its In-Development Blood Test for the Assessment of Malignancy Risk in Patients with an Adnexal Mass
Aspira Women's Health (Nasdaq: AWH) has published data in Gynecologic Oncology demonstrating improved performance of its in-development blood test for assessing malignancy risk in adnexal masses. The study shows that combining miRNA with protein biomarkers, age, and menopausal status offers the most accurate classification for identifying early-stage ovarian cancer.
Key findings include:
- 92% sensitivity at 80% specificity overall
- 80% sensitivity for early-stage cancers
- 100% sensitivity for later-stage cancers
- 78% sensitivity for early-stage, serous ovarian cancers
- 82% sensitivity for early-stage, non-serous cancers
The combined model improved ROC AUC on internal (0.9) and external (0.95) validation sets compared to miRNA alone or proteins plus metadata without miRNA.
Aspira Women's Health (Nasdaq: AWH) ha pubblicato dati su Gynecologic Oncology che dimostrano il miglioramento delle prestazioni del suo test ematico in fase di sviluppo per la valutazione del rischio di malignità nelle masse annessiali. Lo studio mostra che combinare miRNA con biomarcatori proteici, età e stato menopausale offre la classificazione più accurata per identificare il cancro ovarico in fase iniziale.
I risultati chiave includono:
- 92% di sensibilità a 80% di specificità complessiva
- 80% di sensibilità per i tumori in fase iniziale
- 100% di sensibilità per i tumori in fase avanzata
- 78% di sensibilità per i tumori ovarici sierosi in fase iniziale
- 82% di sensibilità per i tumori non sierosi in fase iniziale
Il modello combinato ha migliorato l'AUC ROC nei set di validazione interni (0.9) ed esterni (0.95) rispetto al miRNA da solo o a proteine più metadati senza miRNA.
Aspira Women's Health (Nasdaq: AWH) ha publicado datos en Gynecologic Oncology que demuestran el mejoramiento en el rendimiento de su prueba de sangre en desarrollo para evaluar el riesgo de malignidad en masas anexiales. El estudio muestra que combinar miRNA con biomarcadores de proteínas, edad y estado menopáusico ofrece la clasificación más precisa para identificar el cáncer de ovario en etapas tempranas.
Los hallazgos clave incluyen:
- 92% de sensibilidad con 80% de especificidad en general
- 80% de sensibilidad para cánceres en etapas tempranas
- 100% de sensibilidad para cánceres en etapas avanzadas
- 78% de sensibilidad para cánceres de ovario serosos en etapa temprana
- 82% de sensibilidad para cánceres en etapa temprana no serosos
El modelo combinado mejoró el AUC ROC en conjuntos de validación internos (0.9) y externos (0.95) en comparación con miRNA solo o proteínas más metadatos sin miRNA.
Aspira Women's Health(Nasdaq: AWH)가 산부인과 종양학(Gynecologic Oncology)에 악성 위험을 평가하기 위한 개발 중인 혈액 검사의 성능 향상을 보여주는 데이터를 발표했습니다. 이 연구는 miRNA와 단백질 바이오마커, 연령 및 폐경 상태를 결합하면 조기 난소암을 식별하는 데 가장 정확한 분류를 제공한다고 보여줍니다.
주요 발견은 다음과 같습니다:
- 전체적으로 80% 특이성을 가진 92% 민감도
- 조기 암에 대해 80% 민감도
- 말기 암에 대해 100% 민감도
- 조기 비소세포 난소암에 대해 78% 민감도
- 조기 비소세포 암에 대해 82% 민감도
결합된 모델은 miRNA 단독 또는 miRNA가 없는 단백질과 메타데이터에 비해 내부(0.9) 및 외부(0.95) 검증 세트에서 ROC AUC를 개선했습니다.
Aspira Women's Health (Nasdaq: AWH) a publié des données dans Gynecologic Oncology démontrant l'amélioration des performances de son test sanguin en développement pour évaluer le risque de malignité dans les masses annexielles. L'étude montre que la combinaison de miRNA avec des biomarqueurs protéiques, l'âge et le statut ménopausique offre la classification la plus précise pour identifier le cancer de l'ovaire à un stade précoce.
Les principales conclusions comprennent :
- 92 % de sensibilité avec 80 % de spécificité au total
- 80 % de sensibilité pour les cancers à un stade précoce
- 100 % de sensibilité pour les cancers à un stade avancé
- 78 % de sensibilité pour les cancers ovarien séreux à un stade précoce
- 82 % de sensibilité pour les cancers non séreux à un stade précoce
Le modèle combiné a amélioré l'AUC ROC dans les ensembles de validation internes (0,9) et externes (0,95) par rapport au miRNA seul ou aux protéines plus métadonnées sans miRNA.
Aspira Women's Health (Nasdaq: AWH) hat Daten in der Zeitschrift Gynecologic Oncology veröffentlicht, die eine verbesserte Leistung ihres in Entwicklung befindlichen Bluttests zur Beurteilung des Malignitätsrisikos bei adnexalen Massen zeigen. Die Studie ergibt, dass die Kombination von miRNA mit Protein-Biomarkern, Alter und menopausalem Status die genaueste Klassifizierung zur Identifizierung von frühstageigem Eierstockkrebs bietet.
Wichtige Ergebnisse umfassen:
- 92% Sensitivität bei 80% Spezifität insgesamt
- 80% Sensitivität für Krebs in Frühstadien
- 100% Sensitivität für Krebs in späten Stadien
- 78% Sensitivität für frühzeitig-seröse Eierstockkrebse
- 82% Sensitivität für frühzeitig-nicht-seröse Krebse
Das kombinierte Modell verbesserte das ROC AUC in den internen (0.9) und externen (0.95) Validierungssätzen im Vergleich zu miRNA allein oder Proteinen plus Metadaten ohne miRNA.
- Improved accuracy in identifying early-stage ovarian cancer
- 92% sensitivity at 80% specificity overall in external validation
- 100% sensitivity for later-stage cancers
- Potential to reduce unnecessary surgical interventions
- Advancement in non-invasive diagnostic tools for ovarian cancer
- Test is still in development and not yet commercially available
- Further verification and validation required before market release
Insights
This publication showcases a significant advancement in ovarian cancer diagnostics. The multimodal assay combining miRNA, protein biomarkers, age and menopausal status demonstrates improved accuracy in identifying early-stage ovarian cancer in women with adnexal masses. Key findings include:
- ROC AUC of
95% in external validation 92% sensitivity at80% specificity overall80% sensitivity for early-stage cancers78% sensitivity for early-stage serous ovarian cancers
These results surpass current diagnostic methods, potentially leading to earlier detection and improved patient outcomes. The assay's ability to differentiate between benign and malignant masses could reduce unnecessary surgeries and expedite appropriate treatments.
This development could significantly impact Aspira Women's Health's (AWH) market position and financial outlook. The improved diagnostic accuracy may lead to:
- Increased market share in the gynecologic diagnostics sector
- Potential for higher revenue streams from the new assay
- Enhanced competitive advantage over existing diagnostic tools
However, investors should consider that commercialization timelines and regulatory approvals are not yet specified. The company's ability to translate this research into a marketable product will be important for realizing its financial potential. Keep an eye on future announcements regarding FDA submissions and commercialization strategies.
This innovative assay represents a potential paradigm shift in ovarian cancer diagnosis. The
- Reduce false negatives, enabling earlier interventions
- Minimize unnecessary surgical procedures for benign masses
- Improve surgical planning and patient counseling
The assay's performance across various cancer subtypes, including non-serous types, is promising. However, clinical implementation will require further validation studies and integration into existing diagnostic workflows.
The addition of miRNA and metadata to Aspira’s existing protein assay shows promising improvements in both sensitivity and specificity for early-stage ovarian cancer in women with an adnexal mass
AUSTIN, Texas, Sept. 10, 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 the publication of a paper in the journal Gynecologic Oncology highlighting data demonstrating that a multimodal assay combining miRNA with protein biomarkers, age, and menopausal status offered the most accurate classification of patients with an adnexal mass for the identification of early-stage ovarian cancer.
The study, entitled: “Serum miRNA improves the accuracy of a multivariate index assay for triage of an adnexal mass,” analyzed serum samples from 468 training subjects (191 cancer cases and 277 benign adnexal mass controls or healthy controls) for seven protein biomarkers and 180 miRNAs. Circulating analyte data were combined with metadata, such as age and menopausal status, into a neural network model to classify samples as cases or controls. Forward regression with ten-fold cross-validation minimized the dimensionality of the model while maximizing linear separation between cases and controls.
Results showed that a panel of 10 miRNA delivered optimal performance when combined with protein and metadata features. The combined model improved the Receiver Operator Characteristic Area Under the Curve (ROC AUC) on the internal (AUC = 0.9;
Dr. Todd Papas, Vice President of Research & Development at Aspira Women’s Health, added, “The data are clear in showing that combining miRNA, protein and metadata improves the performance of existing technology in its ability to assess malignancy risk for women with an adnexal mass. The performance is particularly exciting for early-stage cancers and certain subtypes that have previously been more difficult to identify. Our prior research has shown that clinicians struggle to differentiate between benign and malignant masses when they use ultrasound alone, resulting in later diagnosis or unnecessary surgical intervention. We will now move forward with the verification and validation of the assay for our next generation of non-invasive diagnostic tools for ovarian cancer to add to our current OvaSuite offerings.”
Dr. Kevin Elias, the Lilli and Seth Harris Endowed Chair for Ovarian Cancer at the Cleveland Clinic, added, “These results are particularly exciting because they highlight the importance of combining different classes of molecules into next generation assays. This new assay is the most accurate test for ovarian cancer that has ever been described and marks a milestone in cancer diagnostics as the first test to incorporate both proteins and microRNAs. This new approach will ensure that more women get an accurate diagnosis prior to surgical referral.” Dr. Elias continued, “As an ovarian cancer surgeon, I rely on having the most accurate preoperative assessment possible for surgical planning and counseling. This provides a better tool for patient care.”
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 OvaSuiteSM. Together, they provide the only comprehensive portfolio of blood tests to aid in the detection of ovarian cancer 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, EndoCheckSM is the first-ever noninvasive test designed to identify endometriomas, one of the most commonly occurring forms of endometriosis. The EndoMDx 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:
Nicole Sandford
Chief Executive Officer
Investors@aspirawh.com
FAQ
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