Key Questions:

• Question 1: What is the evidence that ovarian cancer genomic tests performed in a
  typical clinical laboratory actually measure what they are purported to measure?

• Question 2: What is the sensitivity and specificity of genomic tests in detecting ovarian
  cancer in asymptomatic and symptomatic women, including high-risk women?

• Question 3: What is the evidence that genomic testing to detect ovarian cancer in
  asymptomatic women, including high-risk women, changes clinical management and leads to improved clinical outcomes?

• Question 4: What is the evidence that genomic testing in women with clinical suspicion
  of ovarian cancer or with already-diagnosed ovarian cancer changes clinical management and leads to improved health outcomes?

• Question 5: What are the harms of using genomic tests for ovarian cancer prevention
  and management?

• Question 6: Has direct-to-consumer and direct-to-physician marketing of genomic tests
  for ovarian cancer increased the “appropriate” use of these tests?

Why EGAPP Selected this topic for Review:

Key criteria: Critical need for reliable early detection due to high case fatality rate of ovarian cancer.

Other Considerations: Collaboration with CDC Division of Cancer Prevention and Control; promotion of new proteomic screening tests when the report was commissioned.