Biocartis Secures FDA Premarket Approval for Idylla™ CDx MSI Test

Biocartis Idylla™ CDx MSI Test Receives FDA Premarket Approval

Biocartis, an innovative molecular diagnostics company, has been granted the first-ever Premarket Approval (PMA) by the U.S. Food and Drug Administration (FDA) for its Idylla™ CDx MSI Test. This significant regulatory milestone, achieved in partnership with Bristol Myers Squibb (BMY), establishes the test as the first fully automated, cartridge-based "sample-to-result" companion diagnostic in the United States for colorectal cancer (CRC) patients.

The Idylla™ CDx MSI Test is designed to identify patients with microsatellite instability-high (MSI-H) colorectal cancer who may be eligible for treatment with Bristol Myers Squibb's OPDIVO® (nivolumab) as a monotherapy or in combination with YERVOY® (ipilimumab).

Innovation in Colorectal Cancer Diagnostics

The approved Idylla™ CDx MSI Test represents a substantial leap forward in oncology diagnostics due to its fully automated, user-friendly design. Operating on the Idylla™ Platform, the test qualitatively detects a panel of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, and SULF2) for MSI detection in CRC tissue samples. Its key advantages include minimal hands-on time, less than three minutes, and rapid delivery of results in under three hours.

Michael Korn, M.D., Chief Medical and Scientific Officer at Biocartis, underscored the impact of this innovation, stating,

"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."

Strategic Partnership and Therapeutic Impact

The FDA approval is the culmination of a strategic collaboration between Biocartis and Bristol Myers Squibb, initiated in 2019, with an initial focus on achieving U.S. registration for the Idylla™ MSI test as a companion diagnostic in metastatic colorectal cancer. The partnership subsequently expanded to pursue registration in other markets, including China.

The clinical utility of identifying MSI-H patients is strongly supported by data from the CheckMate-8HW trial. This trial demonstrated a significant clinical benefit for patients with MSI-H or mismatch repair deficient (dMMR) metastatic colorectal cancer treated with nivolumab plus ipilimumab. Patients who had not previously received systemic treatment showed a 24-month progression-free survival rate of 72% with the combination therapy, compared to just 14% with chemotherapy.

For Bristol Myers Squibb, this diagnostic approval further strengthens the position of their key immuno-oncology drugs. The company recently reported robust performance in Q2 2025, with strong demand for drugs within its Growth Portfolio, including Opdivo, which saw a 7% year-over-year sales increase to $2.6 billion, and Yervoy, which rose 16% to $728 million.

Sarah Hersey, Vice President, Precision Medicine, Bioanalytical and Translational Sciences, Bristol Myers Squibb, commented on the collaboration,

"The approval of this new MSI companion diagnostic for patients with colorectal cancer is a meaningful achievement from our collaboration with Biocartis, and a strong reflection of our Precision Medicine strategy at Bristol Myers Squibb."

Market Implications and Future Outlook

This FDA approval represents a significant commercial and regulatory milestone for Biocartis, potentially expanding its market share in the oncology diagnostics sector. For Bristol Myers Squibb, it enhances the precision and utility of their oncology drug portfolio, aligning with their strategy for targeted therapies. The innovation embodied by the Idylla™ CDx MSI Test is expected to set a new benchmark in colorectal cancer diagnostics, fostering further advancements within the Molecular Diagnostics and Biotechnology sectors.

The Idylla™ CDx MSI Test will be made available across the U.S. soon, with anticipated expansion into other non-U.S. markets subsequently. While specific financial figures for Biocartis were not available in the provided reports, the enhanced ability to identify eligible patients for Bristol Myers Squibb's high-performing oncology treatments suggests a positive outlook for both companies and the patients they serve.