The company has highlighted the study as evidence that its test would outperform Roche's FDA-approved liquid biopsy assay if implemented in the clinic.
An extended labeling claim has added detection of three additional EGFR mutations to help ID NSCLC patients for whom Boehringer Ingelheim's Gilotrif is indicated.
Researchers from France's Gustave Roussy Institute designed EGFR mutation assays for the system, which they showed could be useful for testing in non-small cell lung cancer patients.
The test, miRpredX 31-3p, is a positive theranostic test that quantifies the expression of miR-31-3p in FFPE using RT-qPCR technology.
The changes include recommendations for first line immunotherapy in patients with high PD-L1 expression, and clarification on use of targeted therapies.
The so-called universal CDx approved by the FDA can gauge alterations across multiple genes associated with response to three lung cancer treatments.
Clinicians say they are using blood-based tests for patients who can't be biopsied as a way to get test results sooner, but implementing tests smartly and appropriately remains a challenge.
The company will work with USC researchers in a year-long study aimed at assessing the clinical utility of EntroGen's PCR-based liquid biopsy test for EGFR mutations.
The coverage decision limits the test to patients with advanced lung cancers who haven't been genomically profiled and who can't receive tissue-based testing.
The oncology assay is the first from Roche using either plasma or tumor tissue samples and identifies 42 mutations in the EGFR gene.
The Atlantic reports that genetic counselors are coping with an influx of patients seeking advice on their direct-to-consumer genetic test results.
A small study finds differences between three genomic prostate cancer tests, Medscape reports.
A survey of Canadians finds them to be divided on genetically modified food, the Ottawa Citizen reports.
In Nature this week: shared genetic architecture for asthma and allergic diseases, and more.