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News and reporting on EGFR biomarkers.
Roche's real-time PCR test detects defined mutations of the epidermal growth factor receptor gene in DNA from non-small cell lung cancer patients.
The companies will work together to bring Guardant360 through regulatory approval and commercialize it as a CDx for Janssen's amivantamab.
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.
The high-throughput S2000 sequencer is the second instrument Genetron Health has received NMPA approval for, following the S5 benchtop instrument last year.
The partners will extend the lung cancer biomarker study to countries in and outside Europe, and see if liquid biopsy could offer benefits to tissue-based testing.
An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology.
The researchers aimed to develop a test that could help clinicians determine whether a patient would respond to therapy, before the onset of treatment.
As part of the agreement, Kindstar will use InCellDx's single-cell immuno-oncology and oncology diagnostic products in China, including Hong Kong and Macao.
Labs in China can now use the Cobas EGFR Mutation Test v2 with either tissue or plasma samples as a CDx for three Roche oncology drugs in NSCLC patients.