Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company, announces the US FDA 510(k) submission(1) of its Idylla™ MSI Test(2) for use as an in vitro diagnostic device intended for the identification of microsatellite instability (MSI) status in colorectal (colon) cancer (CRC) to aid in the differentiation between sporadic CRC and potential Lynch syndrome.
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(3). 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(4).
Today, MSI testing is recommended for patients with colorectal cancer for screening for Lynch syndrome(5). However, it is still underused since current methods are highly complex. The Idylla™ MSI Test has been developed to overcome these drawbacks. As a fully automated test, it provides information on the MSI status(6) of CRC tumors within approximately 150 minutes from just one slice of formalin-fixed, paraffin-embedded (FFPE) tumor tissue, without the need of a reference sample.
Commenting on the US FDA 510(k) submission of the Idylla™ MSI Test, Herman Verrelst, Chief Executive Officer of Biocartis, said: “This is a major milestone for the Company as this is Biocartis’ first US FDA submission of an oncology assay. Once the 510(k) clearance is obtained, 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 continue to build momentum in our regulatory program and plan to submit more products to the US 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). A 510(k) or Premarket Notification (PMN) with the US FDA is required when introducing a device into commercial distribution for the first time. Source: https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-denials-and-clearances, last consulted on 19 April 2021
(2) The Idylla™ MSI Test, for use on the Idylla™ system, is intended for the qualitative identification of microsatellite instability (MSI) in colorectal cancer (CRC) tumors and to aid in the differentiation between sporadic CRC and potential Lynch Syndrome. The clinical performance of this device to guide treatment of MSI-H patients has not been established. The Idylla™ MSI Test 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 and subsequent melt-curve analysis. The Idylla™ MSI Test uses a novel set of short homopolymers which were exclusively licensed to Biocartis in 2013 from VIB, the life sciences research institute in Flanders (Belgium), and originated from the research of the group of Prof. Diether Lambrechts (VIB-KU Leuven, Belgium)
(3) Dudley JC et al. (2016) Microsatellite instability as a biomarker for PD-1 blockade. Clin Cancer Res. 22(4):813–820
(4) Source: CDC, last consulted online here on 19 April 2021
(5) Van Cutsem et al. (2016) ESMO Consensus Guidelines for the management of patients with mCRC. Annals of Oncology 27, 1386; NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Colon Cancer V.2.2018. Accessed 25 July 2018. To view the most recent and complete version of the guidelines, go online to NCCN.org
(6) The Idylla™ MSI Test reports results as either microsatellite stable (MSS), or microsatellite instability high (MSI-H) or invalid