Genetic tests are classified in many different categories. Sometimes it can be difficult to understand the differences between the various test categories. Here are some of the most common categories:

Clinical Tests

Clinical tests are tests used for the purpose of diagnosis, prevention or treatment in the care of individual patients.

Points to consider:

  • Laboratories performing clinical tests must be CLIA approved (Clinical Laboratory Improvement Act).
  • There is a charge for clinical tests; cost varies by complexity. Some insurers may not pay for any genetic tests while others may pay for some, but not all.
  • Test results are reported in writing; usually to the ordering provider.
  • The time between specimen submission and reporting of results varies between laboratories and may be based in part on the complexity of the testing.

Research Tests

Research tests are tests used for the purpose of understanding a condition better, or developing a clinical test. There may not be personal benefit to the research participant.

Points to consider:

  • Laboratories performing research testing are not subject to CLIA regulation.
  • The cost of research testing is generally covered by the researcher.
  • Test results are generally not given to patients or their providers.
  • Rarely, a research laboratory will, at the patient's request, share potentially useful findings with a clinical laboratory so the patient's test results can be confirmed and a formal report issued.
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