The authorization implements regulatory strategies the FDA advanced with industry stakeholders, though labs may still be more inclined to take the CLIA route, as long as it is available.

Geisinger is hoping to help others around the country implement precision medicine, which requires significant investment in genomics expertise, as well as infrastructural and operational changes.

The government payor made some adjustments in finalizing the 2018 clinical lab fee schedule, but the industry continues to feel CMS is ignoring its most salient concerns.

The workgroup wanted to address the problem of variability in how bioinformatics pipelines are validated in order to improve the accuracy of NGS tests.

Validation results presented at the Association for Molecular Pathology meeting demonstrate that the test can be implemented clinically, replacing existing FISH and PCR assays.

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.

To deliver winning product solutions, IVD manufacturers must earn the approval of users by addressing the real problems they face. This white paper from Invetech teaches in vitro diagnostics manufacturers how improve IVD system performance, manufacturing, and market success through a user-focused IVD product development process.

Next-generation sequencing (NGS) continues to revolutionize personalized medicine as NGS technology improves and costs continue to fall, resulting in an increased number of scientific and health-related applications. However, the success of a sequencing project rests on the sample quality and NGS library used to generate the data. Poor quality libraries will produce poor quality or biased sequencing data that can slow the advancement and clinical utility of this great new technology.