The agreement will enable Biocartis to commercialize the EGFR S492R resistance mutation as part of its liquid and solid biopsy RUO assays.
The approval includes the use of either tumor tissue or plasma and follows previous approvals with Genentech's Tarceva (erlotinib) and AstraZeneca's Tagrisso (osimertinib).
Genome and RNA sequencing led to recurrent EGFR and BRAF rearrangements in cryptogenic congenital mesoblastic nephroma and infantile fibrosarcoma soft tumors.
The FDA approved its use with tissue or plasma biopsies, giving clinicians a non-invasive option to conduct a test that provides results in a day.
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.
The real-time PCR-based test is designed to identify EGFR mutations in circulating tumor DNA in plasma samples.
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.
The researchers found that most advanced EGFR-mutant lung cancer patients harbored changes in an average of two to three other oncogenes.
The kit detects 29 mutations in exons 18, 19, 20, and 21, and has a limit of mutation detection at .1 percent in a background of wild-type DNA.
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.
According to New Scientist, GEDmatch changed its terms and conditions over the weekend to opt its users out of law enforcement searches.
The Atlantic looks into time spent pursuing gene leads generated through candidate gene studies.
A twin study uncovers evidence that genes may influence whether someone gets a dog, Martha Stewart reports.
In PNAS this week: Cdx2 cells can help regenerate heart tissue in mice following a heart attack, PIWI-interacting small RNA levels in human cancer, and more.