For clinical genomics testing laboratories, validation — and to a certain extent, revalidation — is a fact of life. It’s written into the CAP/CLIA regulations.
The regulations say you must validate:
- Any new FDA-cleared test your lab introduces.
- Any modifications you make to an FDA-cleared test.
- Any laboratory-developed (LDT) test not subject to FDA regulation.
In the case of the first one, validation means you can replicate the performance specifications determined by the manufacturer of the test. In the second two, however, validation involves determining the performance specifications yourself (in seven areas, as outlined by CLIA).
How do you go about testing the accuracy of a test your lab purchased or determining the accuracy of a test your lab designed?