The company hopes that meeting the needs of a more decentralized testing model will increase access to its products for European women with breast cancer.
The policy states that lab tests without FDA's blessing may pursue local coverage via Medicare contractors, but national coverage requires premarket approval or clearance.
The final determination also adds coverage for FDA-approved tests in stage III patients, and for repeat testing if patients receive a new primary diagnosis.
Researchers will study the genetic underpinnings of cancer, heart disease, and respiratory illness by delving into the exome sequencing data from 40,000 Northern Nevadans.
Chugai, a member of the Roche Group, has already filed for regulatory approval of FoundationOne CDx with Japan's Ministry of Health, Labor, and Welfare.
Under the collaboration, Invitae will gain access to Kew's 435-gene tumor profiling NGS panel and proprietary bioinformatics software.
These lobbying efforts aim to shore up willingness among legislators to step in and halt implementation of the NCD if certain provisions remain in the final version.
The companies also agreed to establish a working group to explore the development of standard formulas and definitions for the validation of genomic profiling assays.
The company has received a subpoena from HHS' OIG as part of an investigation into possible improper billing of its hereditary cancer tests to Medicare and Medicaid.
Natera and Qiagen have signed a 10-year agreement to develop cell-free DNA assays for use on Qiagen's GeneReader next-generation sequencing system.
An opinion piece in the Guardian argues that President Donald Trump is uninterested in science and that might not be a bad thing for the field.
The San Francisco Chronicle reports the Veterans Affairs Health System is studying whether genetic testing can help prescribe better depression therapies.
Stat News reports that Spark Therapeutics' Luxturna is now being used to treat a wider array of patients.
In Genome Biology this week: transcription factor use among brittle stars, single-cell RNA sequencing strategy, and more.