The diversity of the organizations that have signed the letter to CMS demonstrates widespread concern over this policy.
The company highlighted growth in demand for its test , and is now ramping up marketing and focusing on its IVD development plans.
The updated guidelines confirm HER2 gene amplification assessed by ISH and protein overexpression assessed by IHC are primary predictors of responsiveness to HER2 therapy.
The company is planning to submit the drug and a companion diagnostic that can identify patients with FGFR alterations with the FDA in the second half of 2018.
A new trial has compared the two most prominent tests, showing that both have clear predictive ability, but leaving several other questions unanswered so far.
The study solidified how doctors should interpret and act upon an intermediate result from the breast cancer risk test in how to treat early-stage patients.
In a new analysis of the trial, researchers concluded that women over the age of 50 with recurrence scores below 25 appear to see no added benefit from adjuvant chemo.
An impetus for the review included the fact that companies are advertising and promoting liquid biopsy in areas where the technology has not yet proven its clinical utility.
The first randomized study to show a PARP inhibitor benefits advanced breast cancer patients is also a sign of the expanding utility of BRCA testing in precision medicine.
Data presented at ASCO showing 76 percent of cancer patients responded to larotrectinib could lead to the availability of the first tissue-agnostic targeted drug.