Smart Biobanking: From Samples to Predictive Algorithm for Detecting Cancer
By Julie Barnes, Ph.D., CEO, Abcodia, and Robert Jones, Director of Fisher BioServices, UK.
This is the story of 20 years of clinical research that has led to the development of a well-validated screening test for ovarian cancer, known as ROCA (the Risk of Ovarian Cancer Algorithm) that successfully identifies early stage disease. Just as significant, this is the story of the establishment of a unique biobank of serum that is now being used to discover and validate additional biomarkers for screening and early diagnosis of other cancers.
The Beginning: Understanding CA-125 in Healthy Women
Carbohydrate Antigen 125 (CA-125) is a well-established biomarker traditionally used to aid diagnosis in women presenting to their doctor with symptoms suggestive of ovarian cancer. In such a setting, levels of CA-125 above an accepted threshold of 30 or 35U/ml have been considered abnormal and a flag to a clinician to do further investigations. However, it is now well understood that the use of CA-125 in a simple quantitative way is limited by its low specificity. Elevated CA-125 levels above 35U/ml not only occur in people with cancer, but can also be found in people with no health problems, as well as in patients with relatively benign conditions, such as endometriosis. Thus, relying on elevated CA-125 results in hundreds of false positives for every one individual accurately diagnosed with cancer.