Tag Archives: companion diagnostics

FDA Announces Diagnostic Testing Measures

FDA has announced it is taking steps to ensure that certain diagnostic tests are accurate, consistent and reliable. The Agency is first issuing a final guidance on the development, review and approval or clearance of companion diagnostics, which are commonly used to detect certain types of gene-based cancers. Second, it will publish a risk-based oversight […]
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Drug-Diagnostic Development Stymied by Payer Concerns

The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy and clinical utility of companion diagnostic tests. Even for the handful of drugs approved by the Food and Drug Administration with labeling that links prescribing to specific biomarker measures, health plan operators, […]
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It's Blind Leading the Blind on Companion Diagnostics

A new report from the Tufts Center for Study of Drug Development (CSDD), confirms that companion diagnostics are an important factor for pharma companies to consider when seeking reimbursement of their drugs. But companies still have a ways to go in allaying the concerns of investors, regulators and payors alike, and fixing this will require […]
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Highlights from the Leerink Swann Healthcare Conference

Over a hundred public companies, dozens of clinicians, and several regulators participated in investment firm Leerink Swann’s 2012 Healthcare Conference in mid-February. Press was barred from the event, but John Sullivan, Leerink’s director of research, gives PharmExec a few of the take-aways.
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