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.
Clinicians say they are using blood-based tests for patients who can't be biopsied as a way to get test results sooner, but implementing tests smartly and appropriately remains a challenge.
The company will work with USC researchers in a year-long study aimed at assessing the clinical utility of EntroGen's PCR-based liquid biopsy test for EGFR mutations.
Researchers describe a way to share data while keeping it secure, Agence France Presse reports.
India's Council of Scientific and Industrial Research has a new director-general, according to ScienceInsider.
A new study links more than a hundred genes to autism spectrum disorder, Discover's D-brief blog reports.
In Science this week: genetic mutations typically associated with esophageal cancer are common in older, healthy individuals, and more.