Carter has made a number of recommendations for the evaluation of molecular tests prior to using them for patient evaluation. A test that passes an initial screen should be scrutinized more closely. The author is from Emory University in Atlanta.
Parameters for the second tier review of a molecular test:
(1) funding source
(2) number of patients in the study
(3) number of controls
(4) test description and methodology
(5) description of gene targets
(6) confirmation of diagnosis in study participants
(7) patient follow-up (to determine the accuracy of any prediction or claims)
(8) significance of test results
Findings
Proceed Further
Red Flag
funding source
non-vendor
vendor
number of patients
many
few
controls
appropriate
none or inappropriate
test description and methodology
well-described
none or poor
description of gene target(s)
well-described
none
confirmation of diagnosis
substantiated
unsubstantiated
patient follow-up
long-term
none or claims not supported
significance of test results
meets a provider's needs
does not meet provider's need
where:
• Unsubstantiated patient selection is based on the patient's own description or claim without confirmation.
The presence of any red flags should result in careful scrutiny of the test.
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