Speed up your therapy decisions and alleviate patient anxiety1.
Test for MSI, KRAS, NRAS and BRAF in only 3 hours and immediately start the right therapy.
Miles, A. (2018). The Psychological Implications of Diagnostic Delay in Colorectal Cancer Patients. In: Olsson, L. (eds) Timely Diagnosis of Colorectal Cancer. Springer, Cham.
In vitro diagnostic tests
IdyllaTM KRAS and NRAS-BRAF Mutation Tests
The IdyllaTM mCRC Test Portfolio provides 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 IdyllaTM 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.1
The IdyllaTM mCRC Test Portfolio includes 2 different RAS mutation tests:
IdyllaTM KRAS Mutation Test IdyllaTM NRAS-BRAF Mutation Test
Sherwood et al. ESMO Open 2017; 2:e000235.
IdyllaTM MSI Test
The IdyllaTM MSI Test provides fast & accurate information on MSI status directly from 1 FFPE colorectal cancer sample.1, 2, 3, 4 , showing high concordance (>97%) and lower failure rates compared to standard methods.5
The use of 7 novel, monomorphic biomarkers provides unbiased test results and eliminates the need for paired normal tissue samples leading to optimal sample stewardship, resource optimization in the lab and eventually improved patient management.
Clinical Performance Study showed 99,7% concordance for MSI testing vs Promega (unpublished data).
De Craene et al. (2018) Journal of Clinical Oncology 36:15 suppl, e15639.
De Craene et al. (2017) Annals of Oncology 28 (suppl_5): v209-v268.
Maertens et al. (2017) Annals of Oncology 28 (suppl_5): v22-v42.
Clinical Performance Study showed 99,7% concordance for MSI testing vs Promega (unpublished data).
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 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.2
BRAF
BRAF mutations are present in 8-15% of CRC cases.3The 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 key biomarker for Lynch syndrome screening and for immune checkpoint inhibition treatment stratification and detection of microsatellite instability (MSI) is currently recommended by guidelines for all newly diagnosed CRC patients.
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; 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.
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;
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