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
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; 95% CI 0.81-0.95) and external validation sets (AUC = 0.95; 95% CI 0.90-0.98) compared to miRNA alone or proteins plus metadata (without miRNA). On external validation, the combined model offered 92% sensitivity at 80% specificity overall, with 80% and 100% sensitivity for early and later-stage cancers, respectively, including 78% sensitivity for early-stage, serous ovarian cancers and 82% sensitivity for early-stage, non-serous cancers.
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 99% and is used to assess ovarian cancer risk for women where initial clinical assessment indicates the mass is indeterminate or benign, and thus surgery may be premature or unnecessary. Ova1Plus is a reflex process of two FDA-cleared tests, Ova1® and Overa®, to assess the risk of ovarian malignancy in women planned for surgery.
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.
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