Ovarian Cancer Screening
Primary results published in worldwide media reports this week suggest a combined blood test and ultrasound, termed a "multimodal" approach, may be the key to screening for ovarian cancer-known as a silent killer because symptoms do not appear until the disease is in its late and deadly stages.
The results of the United Kingdom Collaborative Trial of Ovarian Cancer Screening, led by the University College London, will be published in The Lancet in April. The test measures levels of CA-125, a protein associated with ovarian cancer and used to monitor its progression in patients with the disease.
CA-125 was one of six biomarkers measured by OvaSure, the ovarian cancer screening test LabCorp developed in collaboration with Yale University, and released in June, 2008. While OvaSure seemed like a first step to identifying women with beginning-stage, treatable ovarian cancer, some early fears ran to too many women being identified and the invasive procedures necessary to rule out cancer after a false-positive.
In September, the FDA sent a warning letter to LabCorp expressing concern about how the test was validated, stating OvaSure was "not within the scope of laboratory-developed tests over which the agency has traditionally exercised enforcement discretion."
In a response letter sent in October, LabCorp representatives said the company disagreed with the FDA's position, but would halt sales to maintain a positive relationship with the agency, which they subsequently did.
It will be interesting to see how this multimodal approach differs from OvaSure and if the same concerns will apply.