Aspira Women’s Health Inc. (“Aspira”), a bio-analytical based women’s health company focused on gynecologic disease, announced the commercial launch of OvaWatchSM, a new non-invasive blood-based test for the assessment of ovarian cancer risk in women with adnexal masses. OvaWatch is part of the Company’s OvaSuiteSM portfolio of commercialized ovarian cancer risk assessment tests, including FDA-cleared assays Ova1® and Overa® (Ova1Plus®). With limited exceptions, U.S. physicians will be able to order the test for their patients starting December 1, 2022.

OvaWatch is a multivariate index assay intended to assess the risk of ovarian cancer in women with adnexal masses determined by initial clinical assessment as either indeterminate or benign. With a negative predictive value (“NPV”) of 99%, OvaWatch allows physicians to effectively rule out ovarian cancer malignancy to make more informed clinical decisions.

Utilizing a clinically validated, proprietary algorithm that incorporates seven serum biomarkers and patient features such as age and menopause status, OvaWatch provides a personalized risk assessment score and corresponding negative predictive value. A lower risk score indicates a low probability of malignancy, providing additional confidence in a clinician’s plan to manage and monitor. A higher score does not indicate the presence of cancer; rather, it may guide the clinician to consider additional clinical assessment, specialist consultation or surgery.

Nicole Sandford, CEO of Aspira said, “The launch of OvaWatch is a meaningful step forward in women’s health and a major leap for us as a company. OvaWatch significantly expands the patient population that will benefit from our OvaSuite portfolio and solidifies our position as a leader in the development of life-changing gynecologic diagnostic tools. Early provider interest indicates strong demand for OvaWatch. Our sales force is energized and committed to a successful launch, and we are confident that our in-flight reimbursement strategy will lead to broad payer coverage.”

Gerard Reilly, MD, Director of Clinical Research and Innovation at Axia Women’s Health, and co-author of the OvaWatch paper entitled, “Analytical Validation of a Deep Neural Network Algorithm for the Detection of Ovarian Cancer” said, “Ovarian cancer is one of the deadliest forms of cancer because it is diagnosed most often in the late stages, leaving a tremendous unmet need for early ovarian cancer detection. Meanwhile, over 80% of surgical intervention of women with adnexal masses confirms non-malignant status, rendering significant negative health outcomes for affected women. Widespread use of OvaWatch could help physicians evaluate appropriate care strategies and stratify risk for women presenting with pelvic masses, addressing many of the limitations of current biomarker-based blood tests.”

Ryan Phan, PhD, Chief Scientific Officer at Aspira added, “Physicians have expressed a strong desire for a better tool for the initial clinical assessment of ovarian cancer risk. Building on our clinically proven FDA-cleared platforms, OvaWatch supports physicians’ medical management for a much larger population of women with adnexal masses, compared to the smaller subset with intermediate or high risk masses, throughout all stages of their health journey.”

Dr. Phan continued, “For the first time, physicians can order a test that allows them to confidently develop a medical management plan for all adnexal masses. We believe widespread use of OvaWatch will significantly advance early-stage detection of ovarian cancer and improve the medical management of lower-risk pelvic masses.”

Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. It is the second most common gynecologic cancer in the United States, with nearly 20,000 new cases diagnosed each year. New diagnostic tools can further prevent unnecessary surgical intervention and potential loss of ovarian function.

Following the December 1, 2022 launch to all other states, Aspira expects OvaWatch to be available to New York State patients upon acceptance of its August 2022 submission.

Source: Company Press Release