比利时梅赫伦，2023年3月2日-创新的分子诊断公司Biocartis Group NV（简称 "Biocartis"）（布鲁塞尔泛欧交易所：BCART）今天宣布其全自动Idylla™MSI测试获得美国食品和药物管理局（FDA）510（k）许可^[1]。现在，各种规模的实验室都能从Idylla™的高灵敏度、无可比拟的易用性和快速周转时间中受益。

Mechelen, Belgium, 2 March 2023 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the U.S. Food and Drug Administration (FDA) 510(k) clearance¹ for its fully automated Idylla™ MSI Test. This 510(k) clearance reinforces Biocartis’ commitment to enable clinical molecular diagnostics in the U.S. Now, labs of all sizes can benefit from Idylla™’s high sensitivity, unmatched ease-of-use, and rapid turnaround times.

MSI是人体所谓的DNA错配修复（MMR）系统失活的结果，该系统通常自发地纠正DNA复制过程中发生的错误。如果这个MMR系统不能正常运作，就会发生微卫星不稳定性。在所有结直肠癌中约有15%检测到微卫星不稳定（MSI-H），3%与林奇综合征有关，而其他12%是散发性疾病^[2]。林奇综合征是遗传性结直肠癌的最常见原因，是由影响DNA错配修复的基因的遗传变化（突变）引起的^[3]。

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 disease². Lynch syndrome is the most common cause of hereditary colorectal cancer and is caused by inherited changes (mutations) in genes that affect DNA mismatch repair³.

Idylla™MSI测试仅被批准在Biocartis Idylla™系统上用于体外诊断。Idylla™MSI测试用于Idylla™系统，使用福尔马林固定、石蜡包埋（FFPE）的人类CRC肿瘤组织切片，从中释放出核酸，然后用PCR扩增七个单态生物标志物（ACVR2A、BTBD7、DIDO1、MRE11、RYR3、SEC31A和SULF2）进行分析，随后进行熔融曲线的分析。Idylla™MSI测试将结果报告为微卫星稳定（MSS），或微卫星不稳定性高（MSI-H）或无效。Idylla™MSI测试适用于医护人员对结肠直肠癌（CRC）肿瘤中的微卫星不稳定性（MSI）进行定性鉴定，表明错配修复缺陷，作为对潜在的林奇综合征的一种辅助鉴定，以帮助确定哪些患者将受益于额外的基因测试来诊断林奇综合征。Idylla™MSI测试的结果应由医护人员结合其他临床发现、家族史和其他实验室数据进行解释。Idylla™MSI测试不应该用于诊断CRC。该产品用于指导MSI-H的患者的治疗决策的临床表现尚未确定。

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.

Idylla™MSI测试是一种全自动测试，只需一片福尔马林固定、石蜡包埋（FFPE）的肿瘤组织切片，在大约150分钟内提供关于CRC肿瘤MSI状态的信息，不需要配对的正常组织样本。

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.

Biocartis公司首席执行官Herman Verrelst在评论美国食品和药物管理局（FDA）的510（k）许可时说。"美国食品和药物管理局对肿瘤学检测的首次510（k）许可是公司的一个重要里程碑。由于我们的平台具有完全自动化的样本到结果的特性，美国的大型和小型实验室都有望从这种快速和易于使用的Idylla™MSI测试中受益。我们现在可以开始将我们的体外诊断解决方案商业化，供临床使用，这将释放大量的额外市场潜力，为我们在美国的肿瘤业务持续强劲增长铺平道路。

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.”

参考信息：

[1]510(k)是向FDA提交的上市前通知，以证明将要上市的设备与未获上市前批准(PMA)的合法上市设备一样安全和有效，即基本等同(SE)。510(k)（上市前通知）需要在上市前至少90天提交给FDA，除非该设备被豁免于510(k)要求。 资料来源：https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-denials-and-clearances，最后一次咨询时间：2023年2月28日

[2]Dudley JC et al. (2016) Microsatellite instability as a biomarker for PD-1 blockade.Clin Cancer Res. 22(4):813-820

[3]资料来源:美国疾病预防控制中心.

For more information

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