Quest Launches OVA1, Pegs Market as 1 Million Women Annually

By Kirell Lakhman

Quest and Vermillion have formally launched their OVA1 ovarian cancer test, the companies said today.

The assay, cleared by the FDA last September, is designed to help physicians identify women in whom an ovarian mass is malignant, which would influence who performs the surgery to remove the mass.

The in vitro diagnostic multi-variate index assay combines the results of five protein biomarkers — transthyretin, apolipoprotein A-1, beta2-microglobulin, transferring, and cancer antigen 125 — to produce a single numerical result "to help a physician classify the likelihood that a woman's mass is cancerous or benign," the companies said in a statement.

Quest said most recently in February that it plans to debut the test this month.

Ovarian cancer is the leading cause of death from gynecologic cancers in the US, according to the NCI. By comparison, "ovarian masses affect approximately 1 million women" — OVA1's potential market — "and lead to as many 300,000 ovarian mass surgeries in the US each year," according to an analysis by undisclosed "third parties" on behalf of Quest.

Approximately 21,600 new cases of ovarian cancer will be diagnosed in the US in 2009, and approximately 14,600 women will die of the disease, according to the American Cancer Society.