Biocartis – Idylla for Colorectal Cancer
Biocartis Idylla™ for colorectal cancer
The Idylla solution is a revolutionary, fully automated, real-time PCR based molecular testing system designed to offer results in a minimum amount of time.
Clinical information
RAS
Colorectal cancer (CRC) remains the third most frequent and the second leading cause of cancer-associated mortalities worldwide. Oncogenic mutations in the RAS gene have been identified in ~50% of CRC with activating KRAS mutations identified in 46% and NRAS mutations in 5% of CRC cases.1 BRAF mutations are present in 8-15% of CRC cases.2 RAS mutations are important drivers of tumor resistance against anti-EGFR therapies. Therefore, testing of mutations in exons 2, 3 and 4 of KRAS and NRAS is a requirement prior to initiating treatment with anti-EGFR therapy.3
BRAF
The presence of a BRAF V600E mutation shows to be a poor prognostic factor in patients with mCRC.4 BRAF V600E status can be assessed alongside RAS to guide therapeutic decision making for patients with mCRC.5
MSI
MSI status is a critical marker for the screening of Lynch syndrome and can provide valuable information for prognosis and treatment stratification in colorectal cancers.6 Guidelines recommend assessing the MSI status for all patients with colorectal or endometrial carcinomas for screening for Lynch syndrome as well as for prognostic stratification and potential eligibility for immunotherapy.7, 8, 9, 10 Research studies have shown that MSI-H patients respond favorably to immune checkpoint inhibitors, and checkpoint blockade therapy has recently been incorporated into clinical care for gastrointestinal cancers.11, 12
In vitro diagnostic tests
Speed up your therapy decisions and alleviate patient anxiety13.
Test for MSI, KRAS, NRAS and BRAF in only 3 hours and immediately start the right therapy.
KRAS and NRAS-BRAF Mutation Tests
Idylla solid biopsy tests for mCRC provide fast, reliable information on tumor mutation status for KRAS, NRAS and BRAF reducing the clinical turnaround time significantly to 1-2 days.
In an independent comparison study, the Idylla KRAS Mutation Test outperformed several NGS technologies as well as other PCR-based technologies with regard to sensitivity, turn-around-time and ease of use.14
The Idylla mCRC solid biopsy panel includes 2 different RAS mutation tests:
MSI Test
Our fully automated Idylla MSI Test provides fast and accurate information on MSI status directly from 1 FFPE sample from human colorectal cancer.15, 16, 17, 18
The Idylla MSI Test shows high concordance (>97%) and lower failure rates compared to standard methods.19
The 7 novel biomarkers used for the Idylla MSI Test are tumor-specific eliminating the need for paired normal tissue samples leading to an improved operational efficiency.
The Idylla MSI Test provides unbiased result reporting without the need for visual interpretation.
References:
1 Douillard JY et al. (2014) Ann Oncol; 25:1346-55; Clarke CN, Kopetz ES. (2015) J Gastrointest Oncol 6:660-7.
3 E. Van Cutsem et al.; ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Annals of Oncology 0: 1–37, 2016; NCCN Clinical Practice Guidelines in Oncology – Colon Cancer – Version3.2018; http://www.amp.org/committees/clinical_practice/CRCOpenComment.cfm; Allegra C.J. et al. Extended RAS gene mutation testing in metastatic Colorectal Carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy: American Society of Clinical Oncology Provisional Clinical Opinion Update 2015. Journal of Clinical Oncology 2016; 34(2):179-85.
4 E. Van Cutsem et al.; ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Annals of Oncology 0: 1–37, 2016; NCCN Clinical Practice Guidelines in Oncology – Colon Cancer – Version 3.2018;
5 Cancer Genome Atlas Network (2012) Nature 487:330-7; Douillard JY et al. (2014) Ann Oncol; 25:1346-55; Clarke CN, Kopetz ES. (2015) J Gastrointest Oncol 6:660-7. E. Van Cutsem et al.; ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Annals of Oncology 0: 1–37, 2016; NCCN Clinical Practice Guidelines in Oncology – Colon Cancer – Version3.2018
6 Carethers et al (2004) Gastroenterology. 126:394–401; Ribic et al (2003) N Engl J Med. 349:247–257; Le et al. (2015) N Engl J Med.372:2509–2520.
7 Van Cutsem et al. (2016) ESMO Consensus Guidelines for the management of patients with mCRC. Annals of Oncology 27, 1386.
8 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Colon Cancer V.2.2018. Accessed July 25, 2018. To view the most recent and complete version of the guidelines, go online to NCCN.org.
9 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Rectal Cancer V.2.2018. Accessed July 25, 2018. To view the most recent and complete version of the guidelines, go online to NCCN.org.
10 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Uterine Neoplasms V.2.2018. Accessed July 25, 2018. To view the most recent and complete version of the guidelines, go online to NCCN.org.
11 Le DT et al. (2015) PD-1 blockade in tumors with mismatch-repair deficiency. N Engl J Med. 372:2509-2520.
12 Le DT et al. (2017) Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science 357:409-413.
13 Miles, A. (2018). The Psychological Implications of Diagnostic Delay in Colorectal Cancer Patients. In: Olsson, L. (eds) Timely Diagnosis of Colorectal Cancer. Springer, Cham.
14 Sherwood et al. ESMO Open 2017; 2:e000235.
15 Clinical Performance Study showed 99,7% concordance for MSI testing vs Promega (unpublished data).
16 De Craene et al. (2018) Journal of Clinical Oncology 36:15 suppl, e15639.
17 De Craene et al. (2017) Annals of Oncology 28 (suppl_5): v209-v268.
18 Maertens et al. (2017) Annals of Oncology 28 (suppl_5): v22-v42.
19 Clinical Performance Study showed 99,7% concordance for MSI testing vs Promega (unpublished data).
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