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Aspira Women's Health Preliminary Q4 OVA1 Sales up 23 Percent; Firm Details Pipeline Progess

NEW YORK – Aspira Women's Health on Wednesday announced preliminary Q4 2021 results and provided an operational update.

The Austin, Texas-based company said that for the three months ended Dec. 31, OVA1 volume was up 23 percent to 4,750 tests from 3,849 in the year-ago period.

Aspira also gave updates on two tests in its pipeline, its OvaWatch test for identifying women with likely benign pelvic masses who can safely avoid surgery and be managed by monitoring, and its EndoCheck test, a blood-based assay for helping diagnose endometriosis.

The company said it plans to launch a single-use version of OvaWatch as a laboratory-developed test following acceptance of a pair of manuscripts detailing analytical and clinical validation of the test. It submitted the analytical validation manuscript in November and is planning to submit the clinical validation manuscript. It will launch a serial monitoring version of OvaWatch in late 2022 or early 2023 depending on the timing of publication of data from an ongoing prospective clinical study.

Aspira is developing EndoCheck as an LDT while also applying for US Food and Drug Administration breakthrough designation for the test.

Aspira also said it has entered an agreement with women's healthcare group Axia Women's Health to offer genetic testing on its Aspira Synergy Genetics platform across Axia's 400 providers and 150 women's health centers in New Jersey, Pennsylvania, Indiana, Ohio, and Kentucky.

Under the five-year deal, Axia will be able to perform in-house carrier screening services on its roughly 500,000 patients. Financial and other terms of the agreement were not disclosed.

"The Aspira Synergy Genetics platform leverages novel biochemistry with a clinical-grade AI-based bioinformatics to provide genetics intelligence," Valerie Palmieri, president and CEO of Aspira Women’s Health, said in a statement. "By providing proactive personalized risk assessment at the point of care, we are assisting providers to manage their patients and their families’ germline risks as early as possible. Proactive risk detection is a core mission of our company."