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Will IVDMIA Regs Worsen Already Difficult Reimbursement Environment for PGx Dxs?

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Will IVDMIA Regs Worsen Already Difficult Reimbursement Environment for PGx Dxs?

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If it isn’t already difficult for genetic tests in niche disease populations to find reimbursement, it may soon become “impossible” if the US Food and Drug Administration begins regulating in vitro diagnostic multivariate index assays, a Genzyme official cautioned this week.

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