LDTs

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. 

The Pinnacle assay for gene fusions and gene expression in tumor samples is the first in Cofactor's new line of clinical RNA-sequencing assays.

Glorikian's new book offers guidance for companies looking to develop in vitro diagnostics, on everything from determining value to getting reimbursement.

Pages

Researchers test gene therapy targeting a different cancer protein in a new trial, the New York Times reports.

Pennsylvania State University researchers found that salivary microRNAs could predict which kids would have longer concussion symptoms, according to NPR.

The Associated Press reports Alex Azar, the new Department of Health and Human Services secretary nominee, made millions of dollars as a pharmaceutical executive.

In PNAS this week: immune profiling of breast cancer, transposable element patterns in rice, and more.