Press release Biocartis Group NV: Biocartis Announces US FDA 510(k) submission of its Idylla™ MSI Test
PRESS RELEASE: 20 April 2021, 07:00 CEST
Biocartis Announces US FDA 510(k) submission of its Idylla™ MSI Test
First US FDA Oncology Assay Submission for Biocartis
Mechelen, Belgium, 20 April 2021 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the US FDA 510(k) submission1 of its 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 disease3. Lynch syndrome is the most common cause of hereditary colorectal cancer and is caused by inherited changes (mutations) in genes that affect DNA mismatch repair4.
Today, MSI testing is recommended for patients with colorectal cancer for screening for Lynch syndrome5. 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 status6 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.”
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Renate Degrave
Head of Corporate Communications & Investor Relations Biocartis
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About Biocartis
Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla™ platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis is developing and marketing a continuously expanding test menu addressing key unmet clinical needs, with a focus in oncology, which represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer, as well as for SARS-CoV-2 and sepsis. More information: . Follow us on : @Biocartis_.
Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks owned by Biocartis. Please refer to the product labeling for applicable intended uses for each individual Biocartis product.
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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: , 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 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
