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

The FDA has approved the Idylla CDx MSI test, a fully automated companion diagnostic for colorectal cancer that delivers results in under three hours. By detecting seven key biomarkers, the cartridge-based system identifies MSI-H status, guiding timely use of nivolumab alone or with ipilimumab. For clinicians, this could mean faster treatment decisions and less reliance on central labs. For health system leaders, it raises a bigger question: will same-day MSI testing reshape precision oncology workflows and accelerate access to immunotherapy in CRC?