Companion Diagnostics Guidance Finalized, But LDT Context Will Be Key
This article was originally published in The Gray Sheet
Executive Summary
FDA has finalized its guidance on companion diagnostics with very few revisions from the draft it released three years ago. But the final guidance was released simultaneously with FDA’s much-delayed proposal to begin actively regulating lab-developed tests, which presents important underlying questions for companion diagnostic policy.
You may also be interested in...
High-Risk Companion Diagnostics Need IDEs Prior To Drug Trial, FDA Says
Companies planning to co-develop an in vitro companion diagnostic alongside a therapeutic should be certain that the assay has been analytically validated and, if high risk, has won investigational device exemption before the drug trial begins, FDA warns in a July 14 draft guidance.
High-Risk Companion Diagnostics Need IDEs Prior To Drug Trial, FDA Says
Companies planning to co-develop an in vitro companion diagnostic alongside a therapeutic should be certain that the assay has been analytically validated and, if high risk, has won investigational device exemption before the drug trial begins, FDA warns in a July 14 draft guidance.
FDA Plan To Regulate LDTs Includes Long Phase-In, Unmet-Need Exceptions
FDA said its new plan, which can’t be released as a formal draft guidance for another 60 days, would establish a more level playing field between test-kit makers and labs, while being flexible when there is not an FDA-approved alternative to an lab-developed test.