Where's the personalized medicine? Cries for personalized medicine based on genomic discoveries have gotten louder and louder. But despite compelling research, personalized medicine has been slow to make its way to the clinic, says Pharmalot's Ed Silverman. The reason? "A lack of clinically useful diagnostics," he says. According to a new report from the Tufts Center for the Study of Drug Development, many third-party payors have doubts about whether some tests are clinically useful, and many experts believe that the next five years will only see "moderate growth" in the development of companion diagnostics for already approved drugs, Silverman says. Most likely, the growth of co-developed diagnostics and personalized drugs will also be slow, according to the Tufts report. The list of FDA-approved companion diagnostics is short, and they are mostly partnered with drugs that treat cancer. Insurance companies are also denying or restricting reimbursement on many tests, Silverman adds.
Indeed, our sister publication Pharmacogenomics Reporter notes that the US Centers for Medicare & Medicaid Services is still figuring out a payment structure for genetic tests.