The novel theoretical concept at the core of the Ovation technology is the biological phenomenon that ovarian cancer cells secrete a protein called Bcl-2. Bcl-2 is an anti-apoptotic protein, also called B-cell lymphoma -2. Since Bcl-2 is overexpressed in many tumor types, it contributes to chemoresistance by preventing cell death. Several reports indicate increased expression of Bcl-2 in ovarian cancer compared to normal tissue. Preliminary studies indicate that Bcl-2 secretion is unique to ovarian cancer, as other cancer cell types have solely intracellular Bcl-2. As Bcl-2 is secreted it collects in the urine, and can be detected by methods such as ELISA and lateral flow assays. Current clinical practice for biochemical detection of ovarian cancer status utilizes blood samples or tumor biopsies. Ovation’s assay is novel in that it uses urine, which can be easily collected and stored.

The research studies that support Ovation’s product development were conducted by Dr. Patricia Kruk at the University of South Florida in collaboration with Dr. Robert Bast at MD Anderson. The work was published in 2009 by Gynecologic Oncology. In that publication, urine was collected and assayed for Bcl-2 levels from a total of 77 normal, 161 benign and 150 ovarian cancer cases. Highlights from the studies are as follows:

• Urinary levels of Bcl-2 are elevated in patients with ovarian cancer
• Surgical debulking reduces urinary levels of Bcl-2
• Patients at high risk for ovarian cancer may be predisposed to elevated urinary levels of Bcl-2
• Urinary Bcl-2 complements CA125 measurements

BCL-2 has the promise of being a highly accurate, specific and sensitive marker. The urine based, point-of-care test provides a useful and practical format for monitoring of Ovarian Cancer occurrence in high risk populations.

The Elisa test will provide the opportunity for quantification, making it very useful to monitor patients following surgery and chemotherapy for recurrence.