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Genetron will provide clinical trial genomic testing and companion diagnostic development services for InnoCare's biomarker-driven oncology drug development.
Myriad filed an sPMA for myChoice CDx despite GSK's confidence that Zejula will be approved in newly diagnosed ovarian cancer regardless of biomarker status.
Researchers have identified immune cell gene expression signatures that could one day be developed into tests to predict response to treatment.
AstraZeneca and Merck also announced they have filed for approval of Lynparza in patients who have mutations in more than a dozen homologous recombination repair genes.
The company plans to submit a companion diagnostic version of its sequencing-based liquid biopsy test Guardant360 to various regulatory bodies.
Insight's portfolio includes a gene expression-based immuno-oncology assay for therapy response prediction.
The company is beginning a multi-site Phase II trial designed to establish that its approach can identify patients who will respond to immuno-oncology drugs.
The approval will allow clinicians to identify NSCLC patients with ROS1 fusion genes who could benefit from treatment with Rozlytrek.
The drug is approved as a maintenance treatment for platinum-responsive metastatic pancreatic cancer patients with germline BRCA1/2 mutations.
In patients with Luminal B tumors the CDK4/6 inhibitor ribociclib along with hormonal therapy produced response rates similar to multi-agent chemotherapy.
The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.
The firms will codevelop companion diagnostics for anti-PD1/PD-L1 immunotherapy treatments for cancer.
Promega's microsatellite instability technology will be used to develop an on-label, solid tumor companion diagnostic for pembrolizumab.
The drug has shown in clinical trials to improve outcomes in patients with FLT3 internal tandem duplication and tyrosine kinase domain mutations.
For heavily pretreated ovarian cancer patients, doctors will now have to weigh their HRD status in the context of an increasingly complex backdrop of biomarker information.
The drug is now approved as a fourth-line option for advanced, fallopian tube, or primary peritoneal cancer patients who have homologous recombination deficiency.
Diaceutics is projecting that FDA will soon approve more personalized drugs than all-comer drugs, but absent changes in diagnostics strategies many patients won't receive them.
The assay was developed in partnership with Merck and is intended as a companion diagnostic for that firm's anti-PD-L1 immunotherapy.
Findings from three Phase III clinical trials suggest that PARP inhibitors may prolong disease-free survival in some advanced ovarian cancer patients without BRCA1/2 mutations.
The firms plan to use Thermo Fisher's Oncomine Dx Target test to identify cancer patients with RET alterations who might benefit from Lilly's LOXO-292.