A lack of a lack of clinically useful diagnostics is hindering the
growth of personalized medicines, says a new study from the Tufts Center
for the Study of Drug Development. This lack of evidence is leading
payers in the US to be skeptical about the evidence linking diagnostic
tests to health outcomes. “Scientifically, the process of biomarker
discovery and validation in general, and parallel development of drugs
and companion diagnostics in particular, has been slow. Additionally,
regulatory and reimbursement issues have limited uptake in clinical
practice, particularly with respect to companion diagnostics, but also
for drugs lacking effective diagnostics,” said Joshua Cohen, PhD, senior
research fellow at Tufts and author of the study.
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