Aspira Women’s Health Inc. announced the commercial launch of OvaWatch, 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. 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.