Clinical Verification Of A Novel Blood Test For More Accurate Ovarian Cancer Disease Monitoring

Over 300,000 people/year are diagnosed with ovarian cancer (OC) globally. Unfortunately, the diagnosis and treatment of OC has been very problematic. OC is often diagnosed in late stages due to non-specific symptoms and sub-optimal diagnostics. Once diagnosed, 70% patients will then relapse within 2 years, with only 35% patients surviving for 5 years. Often OC is only diagnosed when it has already spread to secondary locations. The current blood test supporting OC detection, CA125, is wholly inadequate, only raised in ~50% of early stages, or does not detect the cancer until late in the disease progression, and is also raised in a plethora of other benign, unrelated conditions. Clinicians are often faced with difficult tasks when CA125 is rising but a patient presents no symptoms and vice-versa. Often a recurrence can only be detected when it is large enough to be viewed by imaging. A more accurate and earlier detection support tool could enable more frequent monitoring or fast-track patients for further imaging investigation, allowing intervention earlier when second-line treatments may be more effective. This would also reduce referrals for false-positive CA125 readings reducing patient stress, workloads and costs for already stretched healthcare services. GenoME is developing a more accurate and cost-effective blood test for the early detection of OC relapse. We are now aiming to perform clinical verification of our ovarian test in the disease monitoring setting. We will show clinical utility and effectiveness, build the data confidence and accuracy, to progress development towards a clinical trial validation. The OC test (OvaME) is the first product for GenoME. Successful demonstration of OvaME utility will enable us to continue the development required to expand our biomarker pipeline into various other diseases of poor outcomes with unmet clinical need, and other OC indications such as diagnosis.