LDTs

The year brought more FDA approvals for molecularly targeted drugs and NGS tests for personalizing cancer treatment, but reimbursement remained a stress point for industry.

The company is developing an epilepsy test based on inflammatory proteins in patient blood that is intended for ruling out patients with seizure-like symptoms.

The company discussed expectations for how its products will fare against rivals into next year based on recent data and coverage decisions, and on expected reimbursement changes.

Participants shared data from head-to-head assay comparisons, reflected on the advancement of NGS and digital PCR methods, and discussed new standardization projects.

Legislation for LDTs

The US Food and Drug Administration commissioner says that laboratory-developed tests need legislation, according to MedCity News.

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.

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. 

Pages

A new analysis examines the gender gap among paper authors in the sciences and says it may take decades or more to close.

Researchers have uncovered signals of selection that may enable the Bajau people to free five hundreds of feet deep, Reuters reports.

In Science this week: paternally inherited cis-regulatory structural variants in autism, and more.

A new report outlines issues facing the implementation of personalized medicine in the UK, the Independent reports.