Biocartis Receives FDA Approval for First Fully Automated Companion Diagnostic Test for Colorectal Cancer
Key Insights
Biocartis (search) has received FDA Premarket Approval for the Idylla™ CDx MSI Test, marking the first fully automated, cartridge-based companion diagnostic test approved in the US for colorectal cancer (search) patients.
The test identifies microsatellite instability-high (search) (MSI-H) colorectal cancer (search) patients who may benefit from treatment with OPDIVO® (nivolumab) alone or combined with YERVOY® (ipilimumab).
The diagnostic test delivers results in under three hours with less than three minutes of hands-on time, detecting seven monomorphic biomarkers for MSI detection in colorectal cancer (search) tissue samples.
Biocartis (search) Group of Companies has achieved a significant regulatory milestone with FDA Premarket Approval (PMA) for its Idylla™ CDx MSI Test, developed in partnership with Bristol Myers Squibb (search). This marks the first-ever fully automated, cartridge-based, "sample-to-result" companion diagnostic test approved in the United States for colorectal cancer (search) patients.
Breakthrough in Precision Diagnostics
The Idylla™ CDx MSI Test aids in identifying eligible microsatellite instability-high (search) (MSI-H) colorectal cancer (search) patients who may benefit from treatment with OPDIVO® (nivolumab) alone, or in combination with YERVOY® (ipilimumab), as established in the CheckMate-8HW trial.
"The approval of this new MSI companion diagnostic for patients with colorectal cancer (search) is a meaningful achievement from our collaboration with Biocartis (search) and a strong reflection of our Precision Medicine strategy at Bristol Myers Squibb (search)," said Sarah Hersey, Vice President, Precision Medicine, Bioanalytical and Translational Sciences, Bristol Myers Squibb. "Rapid and accurate diagnosis is crucial to enabling access to appropriate therapeutic approaches, and this latest advancement exemplifies our commitment to delivering innovative, targeted solutions that have the potential to improve outcomes for patients."
Technical Specifications and Performance
Designed for use on the Idylla™ Platform, the test qualitatively detects a panel of seven monomorphic biomarkers (ACVR2A (search), BTBD7 (search), DIDO1 (search), MRE11 (search), RYR3 (search), SEC31A (search) and SULF2 (search)) for detection of MSI in colorectal cancer (search) tissue samples. The test runs in a single-use cartridge, requiring less than three minutes of hands-on-time and delivering straightforward results in under three hours.
"Achieving FDA approval for our Idylla™ CDx MSI Test represents a key milestone for Biocartis (search)," said Michael Korn, M.D., Chief Medical and Scientific Officer at Biocartis. "It underscores our commitment to helping oncology patients receive the right therapy without delay and the recent CheckMate-8HW data reinforce the critical importance of accurate MSI-H/dMMR testing in colorectal cancer (search). With its speed, accuracy, and automation, the Idylla™ CDx MSI Test offers a powerful solution that enables clinicians to make timely, confident and data-driven treatment decisions when every moment counts."
Market Availability and Clinical Impact
The Idylla™ CDx MSI Test will be made available across the US soon, with availability in other non-US markets expected to follow. The approval is supported by data from the CheckMate-8HW trial, which demonstrated the efficacy of nivolumab plus ipilimumab in microsatellite-instability-high metastatic colorectal cancer (search) patients.
Biocartis (search)' proprietary Idylla™ Platform delivers in-house molecular biomarker results in only 3 hours, enabling healthcare professionals to make timely, informed decisions that guide personalized therapy. The company's expanding portfolio of diagnostic tests and research assays addresses key unmet clinical needs across multiple cancers, including lung, skin, thyroid, colorectal, endometrial, blood, brain, and breast cancer.