Study evaluates ovarian cancer risk detection in pre-menopausal women
•Patients with and without genetic predisposition that are not planning surgery to be monitored with OVANex
AUSTIN, Texas, June 29, 2020 (GLOBE NEWSWIRE) -- Aspira Women's Health, Inc. (NASDAQ:AWH), a bioanalytical-based women's health company, today announced the first patient enrolled in a national clinical study of benign pelvic mass management. The study will enroll over 1,000 women for assessing ovarian cancer risk in women who have an adnexal mass and a high probability for developing the disease.
"Many women who develop pelvic masses are hesitant to have surgery for a variety of reasons, clinical and personal," said Charles Dunton, MD, Global Medical Director, Aspira Women's Health (AWH). "This study should confirm that this new multi-biomarker test can identify patients that are low risk and can wait to have surgery or perhaps avoid it entirely."
In this recently launched study, ovarian cancer risk will be assessed by a newly developed, multi-biomarker, proprietary algorithm based on AWH's experience and vast specimen bank in developing algorithms and FDA-cleared products for assessing ovarian cancer risk (OVA1® and OVERA®). This study will enroll women in three distinct cohorts; women with pelvic masses without symptoms, women with pelvic masses with indeterminate symptoms, and women without pelvic masses that are high risk for ovarian cancer due to hereditary genetic risk. The primary objective is to determine which patients are low risk and can be monitored without surgery, and which women are at higher risk and need to be sent for further clinical assessment.
"Today there are 1.2-1.5M women in the US with indeterminate pelvic masses which could be monitored. Providing a monitoring test where surgery is not clinically indicated, will help to reassure who is at low risk of developing ovarian cancer, and potentially who can safely wait for surgery or for their mass to resolve," said Valerie Palmieri, President, and CEO of AWH. "Leveraging our proprietary technology with our over 10 years of expertise in Ovarian Cancer Risk assessment, has positioned us to develop this algorithm, and we are pleased to have launched this study. We are now one step closer in bringing this test to ALL women with pelvic masses."