NEW YORK – While OVA1 remains the primary product of Aspira Women's Health, the diagnostics firm is working on a series of new tests that will diversify its offerings in the women's health space.
On the company's Q1 2021 earnings call this week, CEO Valerie Palmieri said that it planned by the end of the year to launch its OVASight test for assessing the risk of ovarian cancer in women with an adnexal mass. Palmieri also noted that Aspira is in discussions with the US Food and Drug Administration around securing breakthrough device designation for its Endocheck test, a blood-based assay intended to aid in the diagnosis of endometriosis.
During the call, Lesley Northrop, chief scientific officer at Aspira, also highlighted the company's work on a test for the early detection of ovarian cancer. In March, Aspira entered an agreement with Dana-Farber Cancer Institute, Brigham and Women's Hospital, and Medical University Lodz to evaluate the use of microRNA along with existing Aspira markers for the development of an ovarian cancer early detection test.
The company's pipeline represents an effort to tap larger markets than are addressable by OVA1, which is intended for use specifically in assessing the risk of cancer in women undergoing surgery for a pelvic mass to help determine whether the surgery can be done safely by an Ob/Gyn or if it should be performed by a gynecologic oncologist.
Austin, Texas-based Aspira has struggled to drive adoption of OVA1 for almost a decade, though it saw a substantial ramp-up in sales in the second half of 2019 as average volumes went from around 2,000 tests per quarter to around 3,500 to 3,800 per quarter.
That momentum slackened as the COVID-19 pandemic hit in 2020. In Q1 2021, OVA1 sales volume was 3,775, up 3 percent from 3,654 in Q1 2020. On the call, Palmieri attributed the modest rise in sales to the continued COVID-19 restrictions and weather disruptions and added that the company saw increasing volumes in March, April, and May.
In any case, despite the improving volumes, OVA1 sales alone are unlikely to bring the company to profitability. The next test in Aspira's pipeline, OVASight, aims to expand on the utility of OVA1. While OVASight is, like OVA1, intended for use in women with a pelvic mass, the test is meant to identify women with likely benign masses who can be safely managed by monitoring, allowing them to avoid surgery. According to the company, there are around 1.2 million to 1.5 million women in the US with indeterminate pelvic masses that OVASight could aid in monitoring, which is around three times the potential market of OVA1.
Elena Ratner, Aspira's chief medical adviser, noted during the Q1 call that the company had recently closed enrollment for a Philippines-based study of the assay, having enrolled 379 patients who will be monitored serially for five years.
Northrup added that Aspira plans to present data on the test's analytical and clinical validation in a poster at the American Society of Clinical Oncology in June and plans to launch the test in Q4 of this year. Aspira also announced this week that it has entered into a research collaboration with Northwell Health's Feinstein Institute for Medical Research through which it aims to study longitudinally its OVAInherit test, a serial monitoring tool for women at high risk of hereditary ovarian cancer that combines the protein panel used for OVAsight with microRNA markers.
OVA1 and OVASight could face competition in the future from diagnostic startup InterVenn, which is working on a mass spectrometry-based glycoproteomic test for triaging pelvic masses and identifying women whose pelvic masses are likely benign and who can safely opt for monitoring over surgery, though the company has not released data on the test since announcing interim results in 2019.
Aspira's Endocheck test offers the opportunity to move into a significantly larger market than that addressed by either OVA1 or OVASight, with, according to the company, around 6 million to 7 million women in the US potential users of the test.
Currently, Northrup said, standard of care for diagnosing endometriosis is laparoscopic surgical assessment, though she noted that the condition is often treated based on symptoms alone, typically with oral contraceptives, and that "surgical diagnosis is becoming rarer."
Northrup declined to provide performance statistics for Endocheck during the call but said that the company was "pleased with our data relative to" surgical assessment.