Agendia
Agendia Gets CE-IVDR Certification for MammaPrint, BluePrint FFPE Breast Cancer Tests
The assays are versions of Agendia’s MammaPrint and BluePrint tests that use formalin-fixed paraffin-embedded tissue samples instead of fresh tissue.
UK's NICE Expands Tumor Profiling Recommendations for Guiding Adjuvant Chemo in Early Breast Cancer
Previously, NICE recommended EndoPredict, Prosigna, and Oncotype DX for node-negative breast cancer only, but the new guidance includes lymph node-positive disease.
NCCN Calls ctDNA Emerging Colon Cancer Prognostic Marker, Does Not Back Use Outside Clinical Trials
The panel noted limited data on whether recurrence risk scores from ctDNA testing or multigene assays predict chemotherapy benefit among colon cancer patients.
Becton Dickinson, DiaSorin, Roche Obtain FDA 510(k) Clearances in September
The clearances from the US Food and Drug Administration include a prognostic assay for breast cancer metastasis, a G6PD deficiency test, and a COVID-19 detection kit.
Agendia Building Validation Data on ImPrint for Guiding Neoadjuvant Immunotherapy in Breast Cancer
Premium
The firm envisions marketing the 53-gene signature with its existing MammaPrint and BluePrint tests as a comprehensive platform for breast cancer treatment selection.