News and reporting on EGFR biomarkers.
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.
The researchers believe using cerebral spinal fluid will enable them to identify brain tumors with a higher sensitivity than with blood samples.
Qiagen's test detects the most frequently occurring somatic mutations in EGFR in less than four hours using real-time PCR on the Rotor-Gene Q platform.
The partners will use a $5M NCI grant to add seven biomarkers to an EGFR electrochemical assay for non-small-cell lung-carcinoma.
Researchers separately found that the assay had high concordance with other techniques in cancers including colorectal and endometrial carcinomas.
The assay can identify KRAS, NRAS, PIK3CA, BRAF, and EGFR gene mutations, as well as 19 gene rearrangements of the ALK, ROS1, RET, NTRK1, and MET genes from FFPE.
The new approval will allow the use of Qiagen's Therascreen EGFR RGQ PCR Kit as a companion diagnostic for Pfizer's Vizimpro in NSCLC patients.