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.
During the meeting, researchers presented studies on combination immunotherapies and the efficacy of giving molecularly-informed treatments earlier in the disease continuum.
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.
Genome and RNA sequencing led to recurrent EGFR and BRAF rearrangements in cryptogenic congenital mesoblastic nephroma and infantile fibrosarcoma soft tumors.
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.
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.
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.
The test, miRpredX 31-3p, is a positive theranostic test that quantifies the expression of miR-31-3p in FFPE using RT-qPCR technology.
The changes include recommendations for first line immunotherapy in patients with high PD-L1 expression, and clarification on use of targeted therapies.
The so-called universal CDx approved by the FDA can gauge alterations across multiple genes associated with response to three lung cancer treatments.
Publication of He Jiankui's work on gene-edited infants would raise ethical concerns for journals, Wired and others report.
The New York Times reports that evidence linking trauma in one generation to epigenetic effects that influence subsequent generations may be overstated.
ScienceInsider reports that US National Institutes of Health researchers were told in the fall they could not obtain new human fetal tissue.
In PNAS this week: skin pigmentation evolution among KhoeSan, biomarkers for dengue virus progression, and more.