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News and reporting on EGFR biomarkers.
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.
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.
The Wall Street Journal reports that Russia's announcement of a coronavirus vaccine approval was met with concern as safety testing has not yet been completed.
New Scientist writes there aren't much data available on the accuracy of the two rapid COVID-19 tests the UK plans to roll out.
In PNAS this week: downstream effect of oncoprotein fusion, epigenetic changes influence tRNAs in colon cancer, and more.
Nature News reports that recent proposed changes to the US National Science Foundation have raised concerns about a shift away from the agency's focus on basic research.