Biomarkers mess: a revolt?

A group of stakeholders including the Critical Path Institute, the Veridex diagnostic unit of Johnson & Johnson (NYSE:JNJ) and multiple universities called for regulatory and reimbursement reform for cancer biomarker tests in a commentary published in Science Translational Medicine on Wednesday. The stakeholders said the development of these tests and adoption into clinical use has lagged behind therapeutics due to a number of factors, including a lack of evidence of analytical validity and clinical utility and inconsistent regulatory standards and reimbursement.

Among the list of recommendations "to improve the landscape" for tumor biomarker tests, the researchers said FDA should require evidence of both analytical validity and clinical utility of biomarker tests prior to approval and ensure laboratory-developed tests (LDTs) are "subject to FDA regulatory controls." The researchers also said government and third-party payers should increase reimbursement for tumor biomarker tests that have clinical utility. Additionally, the researchers said FDA should require all clinical trials for new therapies to be accompanied by a biospecimen bank to support clinical utility for a subsequently generated predictive biomarker, and government, private foundations and industry should all increase investments in trials for tumor biomarker tests.