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 ...
Business Wire

Promega Microsatellite Instability Molecular Test, OncoMate™ MSI Dx Analysis System, CE Marked & Available in Europe

New diagnostic test for MSI in solid tumors can inform physicians on immuno-oncology therapies, and can guide treatment decisions for patients with Lynch-associated cancers LEIDEN, Netherlands & ...
ascopubs.org

Clinical Validity of Plasma-Based Genotyping for Microsatellite Instability Assessment in Advanced GI Cancers: SCRUM-Japan GOZILA Substudy

Validity of 1% Hormonal Receptor Positivity Cutoff by the ASCO/College of American Pathologists Guidelines at the Georgia Cancer Center In 658 patients with advanced GI cancers who underwent both ...
manilatimes

Press Release Biocartis NV: Biocartis Receives European IVDR Certification for the Idylla™ CDx MSI Test

Mechelen, Belgium, 10 March 2026 - Today, Biocartis announced that its Idylla™ CDx MSI Test has received Class C companion diagnostic (CDx) certification under the EU’s IVDR1 as a CDx for colorectal ...
ascopubs.org

Clinical utility of the Idylla CDx MSI test in identifying MSI-H mCRC patients eligible for nivolumab monotherapy or in combination with ipilimumab therapy (CheckMate 8HW phase ...

Clinical performance of liquid RNA (L-RNA) biopsy in a gastrointestinal cancer segment. This is an ASCO Meeting Abstract from the 2026 ASCO Gastrointestinal Cancers Symposium. This abstract does not ...