PRODUCTS

PRODUCTS – CLART® CMA

CLART® CMA is an in vitro diagnostics test line of products for the detection of mutations in genes associated with response to therapy in cancer patients. Products CLART® CMA are based on CLART® Technology, and in particular on Multiplex PCR amplification followed by visualization in low-density arrays.

CLART® CMA KRAS·BRAF·PI3K:

Detection and differentiation of 15 point mutations associated to response to therapy in patients with metastatic colorectal cancer.

LART®CMA NRAS·iKRAS:

Detection and differentiation of 10 point mutations associated to response to therapy in patients with metastatic colorectal cancer.

The exact mutations to be detected with CLART® CMA KRAS·BRAF·PI3K and CLART® CMA NRAS·iKRAS kits are:

The design of these kits allows the user to perform an analysis on demand by combining the different amplification references according to the necessities of the lab, and visualizing all together using just one array per kit.

CLART® CMA EGFR:

Detection and differentiation of 40 point mutations, deletions and insertions associated with response to therapy in non-small-cell lung cancer patients. The exact mutations to be detected with CLART® CMA EGFR kit are:

 CLART® CMA EGFR LB – Liquid Biopsy.

The EGFR test kit is now available for blood samples.

CLART® CMA ALK·ROS1

Detection and genetic identification of major chromosomal translocations in ALK and ROS1 genes associated with response to therapy in patients with lung cancer.

CLART® CMA BRAF·MEK1·AKT1:

Detection and differentiation 6 point mutations associated with response to therapy in patients with melanoma.

Advantages of CLART® CMA diagnostics:

  • Minimum amounts of sample are required, the remaining tissue being preserved for future or parallel studies.
  • All reagents and components are supplied ready to use, the hands-on time invested on the technique being significantly reduced.
  • CLART® CMA diagnostics constitutes an optimization of existing protocols, improving the laboratory workflow.
  • It is a tool to detect chimeric tumors, to distinguish between primary and metastatic tumors, to establish the most adequate treatment or to predict response to medication.

 

CLART® CMA KRAS·BRAF·PI3K, CLART® CMA NRAS·iKRAS and CLART® CMA EGFR kits comply with EU directive EU 98/79/CE for IVD.

Data of Sensitivity and Specificity values, validated sample types, quality controls used and Automatic Reading and Interpretation of Results of each kit may be checked in the corresponding User Manual.

 

Bibliography

1. “Biomarkers Predicting Clinical Outcome of Epidermal Growth Factor Receptor-Targeted Therapy in Metastatic Colorectal Cancer”. Review J Natl Cancer Inst 2009;101:1308–1324

2. “Effects of KRAS, BRAF, NRAS, and PIK3CA mutations on the efficacy of Cetuximab plus chemotherapy in chemotherapy-refractory metastatic colorectal cancer: a retrospective consortium analysis”. Lancet Oncol 2010; 11: 753–62.

3.“KRAS, BRAF, PIK3CA, and PTEN mutations: implications for targeted therapies in metastatic colorectal cancer”. Lancet Oncol 2011; 12: 594–603.

4. “Molecular Mechanisms of Resistance to Cetuximab and Panitumumab in Colorectal Cancer”. J Clin Oncol 2010 28:1254-1261.

5. “NRAS and KRAS testing by a new diagnostic method to detect point mutations in colorectal cancer specimens: CLART NRAS·iKRAS. 2014