LDTs

Geneticists and periodontists point to financial conflicts, the lack of genetics knowhow, and regulatory gaps for the availability of a test they say should have never come to market.

Entering a new chapter with a new leader, ACLA lends support to a draft bill that would regulate lab tests not as medical devices but as in vitro clinical tests.

The AACC called for increased collaboration between physicians and laboratory medicine professionals, as Medicare changes how it reimburses for clinical lab tests.

Chromosomes

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.

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