OvaWatch forms part of the OvaSuite portfolio. Credit: Billion Photos via Shutterstock.

Aspira Women’s Health has received approval from the New York State Department of Health’s (NYDOH) Clinical Laboratory Evaluation Program (CLEP) to market its ovarian cancer test OvaWatch in New York, US.

The CLEP approval is a critical step for lab-developed tests, confirming compliance with the state’s clinical laboratory regulations.

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Launched in November 2022, OvaWatch is reported to be the only noninvasive blood test available for evaluating ovarian cancer risk in patients with an adnexal mass initially deemed indeterminate or benign.

The test has a 99% negative predictive value and features longitudinal monitoring, enabling physicians and patients to tailor treatment plans.

Aspira Women’s Health CEO Nicole Sandford said: “We are gratified to have secured CLEP approval for OvaWatch opening the door to one of the nation’s largest healthcare markets with over ten million women residing in New York state.

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“Additionally, with a process that some view as equal to or more stringent than some at the federal level, we believe that CLEP 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.”

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The company offers OvaWatch as part of OvaSuite, which also includes Ova1Plus.

Ova1Plus combines two US Food and Drug Administration-cleared tests, Ova1 and Overa, to evaluate the risk of ovarian malignancy in women scheduled for surgery.

Aspira Women’s Health signed an exclusive licensing agreement with Dana-Farber Cancer Institute to develop a new ovarian cancer diagnostic test using microRNA technology in May 2023.