There are currently no reliable tests for the early detection of ovarian cancer. We are developing Ovation to change that. Ovation will offer an efficient, noninvasive, and affordable means of detecting this terrible disease in the earliest of stages. Our novel biomarker is present in urine samples of women suffering from ovarian cancer, ensuring that Ovation will be convenient and feasible for use in a primary care setting. With Ovation, our dream is not only to make early detection possible, but also simple.

1.2% of women will be diagnosed with ovarian cancer during their lifetimes. Despite its widespread prevalence, there is currently no reliable test for the early detection of ovarian cancer. In fact the average time of diagnosis is at stage 3c. This lack of early detection has significant impact on a person’s prognosis, as survival rate decreases by 60% when diagnosed in late vs. early stage. Millions of lives could be saved with a reliable test for early detection.

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.

Ovation is designed to make early detection both possible and convenient. Key benefits of the test include:

  • Non-invasive: The test is based on a urinary biomarker, meaning that it will be simple, painless, and convenient to administer in any care environment
  • Superior Sensitivity and Specificity: Bcl-2 shows higher accuracy than the standard ovarian cancer test (CA-125) across 350+ patients, and is not elevated in healthy women and those with benign gynecological disease
  • Stage Sensitivity: Urinary Bcl-2 levels are directly proportional to the stage of ovarian cancer
  • Evaluating Success of Surgical Intervention: Bcl-2 is reduced to normal levels upon successful surgical removal of malignant masses