Biocartis announces the US FDA 510(k) clearance for the Idylla™ MSI Test

MSI is the result of inactivation of the body’s so-called DNA mismatch repair (MMR) system, which normally spontaneously corrects errors that occur during DNA replication. In case this MMR system does not function properly, microsatellite instability occurs. MSI-High (MSI-H) is detected in approximately 15% of all colorectal cancers and 3% are associated with Lynch syndrome, whereas the other 12% have sporadic disease (2). Lynch syndrome is the most common cause of hereditary colorectal cancer and is caused by inherited changes (mutations) in genes that affect DNA mismatch repair (3).

The Idylla™ MSI Test is cleared for in-vitro diagnostic use on the Biocartis Idylla™ System only. The Idylla™ MSI Test, for use on the Idylla™ System, uses formalin-fixed, paraffin-embedded (FFPE) tissue sections of human CRC tumor, from which nucleic acids are liberated, then analyzed using PCR amplification of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) and subsequent melt-curve analysis.  The Idylla™ MSI Test reports results as either microsatellite stable (MSS), or microsatellite instability high (MSI-H) or invalid. Idylla™ MSI Test is indicated for use by healthcare professionals for the qualitative identification of microsatellite instability (MSI) in colorectal cancer (CRC) tumors, indicative of mismatch repair deficiency, as an aid in the identification of potential Lynch syndrome to help identify patients that would benefit from additional genetic testing to diagnose Lynch syndrome.  The results from the Idylla™ MSI Test should be interpreted by healthcare professionals in conjunction with other clinical findings, family history, and other laboratory data. The Idylla™ MSI Test should not be used for diagnosis of CRC. The clinical performance of this device to guide treatment decision for MSI high patients has not been established.

The Idylla™ MSI Test is a fully automated test, that provides information on the MSI status of CRC tumors within approximately 150 minutes from just one section of formalin-fixed, paraffin-embedded (FFPE) tumor tissue, without the need for paired normal tissue sample.

Commenting on the U.S. Food and Drug Administration (FDA) 510(k) clearance Herman Verrelst, Chief Executive Officer of Biocartis said: “This first US FDA 510(k) clearance of an oncology assay is a major milestone for the Company. Both large and small US labs are expected to benefit from this fast and easy to use Idylla™ MSI testing thanks to the fully automated sample-to-result nature of our platform. We can now start to commercialize our in-vitro diagnostic solution for clinical use, which will unlock significant additional market potential and pave the way for continued strong growth of our oncology business in the U.S. We continue to build momentum in our regulatory program and plan to submit more products to the U.S. FDA, also supported by our pharma partners.”

(1) A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements. Source: https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-denials-and-clearances, last consulted on 28 February 2023
(2) Dudley JC et al. (2016) Microsatellite instability as a biomarker for PD-1 blockade. Clin Cancer Res. 22(4):813–820
(3) Source: CDC, last consulted online here on 27 February 2023