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News and reporting on EGFR biomarkers.
The companies will work together to bring Guardant360 through regulatory approval and commercialize it as a CDx for Janssen's amivantamab.
The company will start Phase I/II trials to evaluate the safety and anti-tumor activity of its natural killer cells in combination with Herceptin or Erbitux in the third quarter of 2020.
The agency based its decision on a trial showing that patients receiving the combo had a median PFS of 19.4 months versus 12.4 months for those on Tarceva.
At AACR's annual meeting, a researcher described how the breakthrough therapy designated drug was designed specifically to overcome the challenges of targeting EGFR exon 20 insertions.
Data amassed by analytics firm Diaceutics suggests fewer patients are coming into healthcare facilities and missing the chance for diagnosis, molecular testing, and treatment.
While the guidance may lead to more streamlined CDx indications in precision oncology, test developers will still need to generate evidence, perhaps with limited pharma support.
Affimed announced the first patient dosed in a Phase I/IIb trial of AFM24, designed to bind CD16A receptors on innate immune cells and EGFR receptors on tumor cells.
The drug, JNJ-6372, is currently being studied in non-small cell lung cancer patients with EGFR exon 20 insertion mutations.
The precision oncology startup is gearing up to enroll patients in its tissue-agnostic Phase I/II trial for its investigational new drug BDTX-189.
The high-throughput S2000 sequencer is the second instrument Genetron Health has received NMPA approval for, following the S5 benchtop instrument last year.