Advanced Diagnostics: Innovation, Reimbursement, And Coverage Challenges
Developers of novel advanced diagnostics tests face many challenges that dramatically constrain both innovation and the ability to provide new tests to clinicians and patients. Recently, planned changes in pricing detailed in the Protecting Access to Medicare Act of 2014, and new guidelines on evidence development have been put forward and in some cases adopted – will these recent changes address the challenges?
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Life sciences attorneys expect the Supreme Court’s ruling that isolated DNA is not patentable will invalidate thousands of patents; it is unclear whether medicinal molecules isolated from nature or made synthetically are impacted by the decision.
Supreme Court unanimously holds that DNA isolated from the human body cannot be patented but cDNA, which is created in a laboratory, can; Patent and Trademark Office tells examiners to reject product claims drawn solely to naturally occurring nucleic acids or their fragments.