Vermillion has long its OVA1 In Vitro Diagnostic Multi-Variant Index Assay (IVDMIA) for ovarian cancer. OVA1 is one of a handful of FDA approved IVDMIAs and was predicted to have a much greater market presence than actually occurred, despite its partnership with Quest Diagnostics, the largest commercial reference lab in the US. Now, Vermillion announced that the company has terminated its licensing agreement with Quest for OVA1 and Vasclir diagnostic tests.[protected]CEO Thomas McLain said that following the termination of their long standing relationship, Vermillion would be able to offer OVA1 through other reference labs and gain greater market penetration and revenues.
This remains to be seen as Vermillion faces not only marketing challenges but reimbursement ones as well. Vermillion is facing significant challenges from the changing regulatory and reimbursement environments in the US, noting, especially an April ruling by BlueCross BlueShield’s Technical Evaluation Center that classified OVA1 as “experimental/investigational.” This ruling led to 10 BCBS plans reversing their positive coverage decisions for OVA1. This ruling led to 10 BCBS plans reversing their positive coverage decisions for OVA1.
The American Cancer Society estimates that 21,600 new cases of ovarian cancer will be diagnosed in 2009 and 14,600 women will die from the disease. Ovarian cancer is referred to as the “silent killer” because it is difficult to detect at early, curable stages. CA-125, a biomarker for ovarian cancer has long been used to diagnose this disease along with ultrasound. However, studies have shown that they do not reliably detect ovarian cancer at curable stages.
For more information on IVDMIAs, Laboratory Developed Tests (LDTs), regulatory issues and the $52 billion global clinical diagnostic market and segments, please contact your Atheneum Partners representative today to schedule an individual consult. [/protected]