NEW YORK – Aspira Women's Health said after the close of markets Tuesday that it has received approval for its OvaWatch ovarian cancer test from the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP).
OvaWatch is a blood test intended for assessing ovarian cancer risk in women with an adnexal mass that has been determined by clinical assessment to be indeterminate or benign.
With the CLEP approval, Aspira can offer OvaWatch to patients in New York state.
"We are gratified to have secured CLEP approval for OvaWatch opening the door to one of the nation's largest healthcare markets with over 10 million women residing in New York state," Aspira CEO Nicole Sandford said in a statement, adding that the company believes the approval "provides important validation of the rigorous science behind our test, strengthens our credibility in other markets, and positions us well for other regulatory pathways."