A strong FDA could pull molecular-diagnostics industry out of a rut

02/18/2014 | Xconomy

Molecular diagnostics have the potential to reduce waste and overtreatment while helping patients, but the field is stuck in a rut, Luke Timmerman writes. "The molecular diagnostics industry needs a tough, science-minded, credible regulator ... who can comb through complex data sets and say with confidence what's real, what's clinically meaningful" and what isn't, he writes. A lack of regulations on companion diagnostics fosters skepticism among payers and investors, Timmerman writes.

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