Healio

FDA grants premarket approval to Idylla CDx MSI test for patients with colorectal cancer

Please provide your email address to receive an email when new articles are posted on . The FDA has approved the Idylla CDx MSI test — a fully automated, “sample-to-result” companion diagnostic — for ...

Waiv Achieves Dual CE Marking Under IVDR, Propelling AI Precision Testing for Breast and Colorectal Cancer for Clinical Routine

Waiv, formerly Owkin Dx, a company advancing AI precision testing, today announced that two of its AI precision tests, RlapsRisk® BC for breast cancer prognostic risk profiling and MSIntuit® CRC for ...
ascopubs.org

Multi-site blinded validation of a deep learning approach for clinical-grade MSI/dMMR detection in colorectal cancer from H&E-stained pathology images.

Association between visceral adipose tissue radiodensity and overall survival among older adults with colorectal carcinoma. Blinded validation results of PPC with confidence intervals (CI) at 95%.
BioWorld

FDA approves Biocartis Idylla Cdx MSI colorectal cancer test

Biocartis Group NV received premarket approval from the U.S. FDA for its Idylla Cdx MSI test, developed in partnership with Bristol Myers Squibb Co., to help in the diagnosis and treatment of ...