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The AACC called for increased collaboration between physicians and laboratory medicine professionals, as Medicare changes how it reimburses for clinical lab tests.
The firm's first assay will be for Hodgkin lymphoma, but a liquid biopsy test for prostate cancer has also shown strong predictive power in initial validation data.
The firm has settled on a set of metabolite biomarkers, along with an algorithm, for its first version of a test for arterial plaque buildup.
The draft bill, based on a proposal developed by a coalition of Dx manufacturers and labs, would split oversight responsibilities across the FDA, CMS, and states.
Glorikian's new book offers guidance for companies looking to develop in vitro diagnostics, on everything from determining value to getting reimbursement.
At the Personalized Medicine World Conference, stakeholders and the former FDA commissioner discussed how regulation can advance personalized medicine amid political uncertainty.
The white paper, while not enforceable, addresses the lab industry's concerns and makes a public health case for FDA oversight of LDTs.
Mertz outlined the lab industry group's policy positions after FDA's decision to delay final guidance on regulation of lab tests and upcoming implementation of a payment law.
The guidance may be dead, but the issues underlying the controversy aren't, according to Gibbs, who said the agency can still take enforcement action against specific tests.
According to multiple sources in Washington, DC, the FDA has been informing stakeholders in policy circles of the decision.