The firm also recently released the results of collaborations with Admera Health and RareCyte that used its multiplex PCR-based target enrichment technology.
In a survey conducted by an association working group, 40 percent of respondents said they are already offering TMB, with most others planning to do the same within the year.
Frederick National Lab and Q2 Solutions have been validating the kit as early users and plan to implement it in their clinical trial services.
The research-use-only system, which has a list price of $299,000, fits with Thermo Fisher's vision of a future of disseminated implementation of NGS.
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology.
The group notes the importance of lab CLIA certification, clear test reports, and clinical validity support for test claims in the literature, guidelines, and FDA labels.
As NGS testing becomes more widespread, labs, payors, and professional groups confront questions about which genes should be required as part of clinical assays.
The organizations provided a list of genes they believe are informative in treatment of myeloid disorders and suggested several changes to the coverage policy.
The organization continues to support direct access genetic testing for healthcare decision making, while remaining neutral on recreational, novelty, lifestyle, and ancestry genetic testing.
Gene editing could be an issue competitive sports need to address soon, four researchers from Arizona State University write at Slate.
A genetic alteration appears to increase heart failure risk among people of African descent, according to the Washington Post.
In his look back at the past decade, BuzzFeed News' Peter Aldhous writes that direct-to-consumer genetic testing has led to "Facebook for genes."
In Nature this week: genetic "clock" that can predict the lifespans of vertebrates, new assembler called wtdbg2, and more.