Eleven laboratories that are part of Thermo's OncoNetwork Consortium tested the Oncomine Lung cfDNA assay on reference samples.
The groups said they hope their recommendations lead to higher-quality sequencing results in the lab and better care for cancer patients in the clinic.
The guidance includes recommendations for extended RAS mutation testing to guide anti-EGFR therapy, as well as updated endorsements for analysis of mismatch repair status.
The recommendations were developed by a working group of the AMP Clinical Practice Committee that included representatives from ACMG, ASCO, and CAP.
According to multiple sources in Washington, DC, the FDA has been informing stakeholders in policy circles of the decision.
The US Supreme Court decision cleared the way for large-scale sequencing or drove prices to unsustainable levels, depending on your opinion.
A hospital study demonstrated an average total cost saving of around $25,000 for each patient with candidemia.
The new assays — one targeting 17 genes and one targeting 77 genes — are based on the CAPP-Seq technology developed by Stanford University
Merck is hoping NanoString's multiplex platform can support gene expression signatures that will better predict which patients will respond to checkpoint inhibitors like its Keytruda.
Clinical MDx firm OmniSeq has been an early-access user of the research-use-only assay and is working on validating it to predict checkpoint inhibitor response.