Aspira Women’s Health has launched the new OvaWatch test to assess the risk of ovarian cancer in women with adnexal masses.
The new, non-invasive blood test has been designed for evaluating the risk of ovarian cancer for women with adnexal masses that have been considered indeterminate or benign in initial clinical assessment.
It helps physicians rule out ovarian cancer malignancy and make better clinical decisions.
OvaWatch is a multivariate index assay that provides a single risk assessment score, with a 99% negative predictive value (NPV).
It is said to be part of Aspira Women’s Health’s OvaSuite portfolio of ovarian cancer risk assessment tests, which includes the US Food and Drug Administration (FDA)-approved Ova1 and Overa (Ova1Plus).
The OvaWatch blood test uses a clinically validated, proprietary algorithm, which includes seven serum biomarkers as well as patient features, such as age and menopause status.
It provides a customised risk assessment score along with the corresponding NPV.
Aspira CEO Nicole Sandford 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 energised and committed to a successful launch, and we are confident that our in-flight reimbursement strategy will lead to broad payer coverage.”
The company expects that the new diagnostic tools can prevent unnecessary surgical intervention and ovarian function loss.
Physicians in the US can order the OvaWatch test for their patients from 1 December.