ColoNode® (IVD)
ColoNode® includes ready to use reagents for analysis of 20 colorectal cancer lymph node RNA samples for analysis of the five biomarkers CEACAM5, KLK6, SLC35D3, POSTN and MUC2 and the housekeeping gene 18S rRNA, and a web-based software that calculates the result in terms of tumor cell detection and risk of tumor recurrence after surgery.
Specimen Requirements:
Today only about 1 % of each lymph node is analyzed in clinical routine after surgery for patients with colorectal cancer. With ColoNode®, up to 100% of each lymph node can be analyzed.
The ColoNode®-kit is intended for analysis of total-RNA extracts of lymph node tissue of colorectal cancer patients.
- The concentration should be within the interval of 100 – 800 ng/µL
- RNA samples should be free from potential PCR inhibiting factors, OD260/OD280 ratio should be >1.8
ColoNode® increases detection of metastases/micrometastases 1.33-fold compared to histopathology (H&E)
This figure shows the results from side-by-side analysis of 185 lymph nodes comparing histopathology (H&E) and CEACAM5 levels by ColoNode. All H&E-positive lymph nodes have high CEACAM5 levels. Notably, 7 H&E negative lymph nodes have as high CEACAM5 levels, thus harboring similar amounts of tumor cells as H&E-positive nodes but missed by histopathology. The CEACAM5 levels of these lymph nodes and the H&E-positive nodes are all higher than the “clinical cut-off” above which there is an increased risk of recurrence1 .
Additional 26 lymph nodes have detectable CEACAM5 mRNA just below the clinical cut off, meaning no micrometastasis but still isolated tumor cells.2
- 1Ohlsson L, Israelsson A, Öberg Å, Palmqvist R, Stenlund H, Hammarström M-L, Hammarström S, Lindmark G. Lymph node CEA and MUC2 mRNA as useful predictors of outcome in colorectal cancer. Int J Cancer. 2012;130:1833-1843. doi: 10.1002/ ijc.26182. PMID: 21618511. Olsson LM, Lindmark GE, Israelsson ACE, Korkocic D, Hammarström SG, Hammarström M-LKC. CEACAM5, KLK6, SLC35D3, POSTN and MUC2 mRNA analysis improves detection and allows characterization of tumor cells in lymph nodes of colon cancer patients. Dis Colon Rectum. 2021;64:1354-1363. doi: 10.1097/DCR.0000000000002151. PMID: 34192710.
- 2Ohlsson L, Israelsson A, Öberg Å, Palmqvist R, Stenlund H, Hammarström M-L, Hammarström S, Lindmark G. Lymph node CEA and MUC2 mRNA as useful predictors of outcome in colorectal cancer. Int J Cancer. 2012;130:1833-1843. doi: 10.1002/ ijc.26182. PMID: 21618511. Olsson LM, Lindmark GE, Israelsson ACE, Korkocic D, Hammarström SG, Hammarström M-LKC. CEACAM5, KLK6, SLC35D3, POSTN and MUC2 mRNA analysis improves detection and allows characterization of tumor cells in lymph nodes of colon cancer patients. Dis Colon Rectum. 2021;64:1354-1363. doi: 10.1097/DCR.0000000000002151. PMID: 34192710.
Increasing the amount of tissue analyzed improves detection
Examples from ColoNode analyses of RNA extracts of one 80 µm section compared to half the lymph node. High levels of CEACAM5 and aggressiveness markers KLK6 and SLC35D3 were seen in both 80 μm sections and half nodes in 2 lymph nodes that had a metastase according to histopathology [=H&E(+)]. In H&E- lymph nodes however, it was critical to analyze half the lymph node to detect CEACAM5, KLK6 and SL35D3 at significant levels. 1
- 1Olsson LM, Lindmark GE, Israelsson ACE, Korkocic D, Hammarström SG, Hammarström M-LKC. CEACAM5, KLK6, SLC35D3, POSTN and MUC2 mRNA analysis improves detection and allows characterization of tumor cells in lymph nodes of colon cancer patients. Dis Colon Rectum. 2021;64:1354-1363. doi: 10.1097/DCR.0000000000002151. PMID: 34192710.
Risk categorizing of patients based on aggressiveness markers
Based on the aggressiveness markers in the ColoNode®, there is a possibility to allocate patients to three categories with different risk for recurrence. These risk categories proved to be prognostic factors independent of TNM-stage and tumor grade, which could support decisions on adjuvant chemotherapy and follow-up.1
- 1Olsson L, Hammarström M-L, Israelsson A, Lindmark G, Hammarström S. Allocating colorectal cancer patients to different risk categories by using a five-biomarker mRNA combination in lymph node analysis. PLoS ONE. 2020;15:e0229007. doi: 10.1371/ journal.pone.0229007. eCollection 2020. PMID: 32049988.
