Gene Expression Test Detects and Characterizes Tumor Cells in Lymph Node after Surgery

9 million new cases and 0.9 million fatalities each year. Surgery to remove the tumor is a treatment option for 70-90% of CRC patients. The tumor-node-metastasis (TNM) staging system, included in international guidelines, evaluates the primary tumor (T), lymph node metastasis (N), and distant metastasis (M) to estimate the likelihood of disease recurrence and survival rates. A critical element of this system is examining lymph nodes found in the resected colon section for disseminated tumor cells. Lymph node status also plays a crucial role in determining the necessity of post-operative adjuvant chemotherapy. The standard method for identifying lymph node status (pN) is by analyzing H&E stained lymph node tissue sections under a microscope. This approach has drawbacks, such as being insensitive and subjective, needing expert pathologists, assessing less than 1% of the lymph node volume, and not distinguishing between aggressive and relatively benign tumor cells. Now, a gene expression signature test can enhance the detection of nodal metastasis in CRC patients, leading to better disease staging.

Hiloprobe AB’s (Umeå, Sweden) ColoNode is a CE-marked IVD gene expression test that identifies and categorizes cancer cells in post-operative CRC lymph node specimens. This multiplex qRT-PCR assay can analyze up to 100% of the lymph node volume, providing more sensitivity in detecting tumor cells compared to H&E staining. The test also estimates the risk of CRC recurrence based on the tumor aggressiveness markers included in the ColoNode kit. ColoNode identifies and characterizes cancer cells in lymph nodes by evaluating mRNA levels of five biomarkers and estimates the likelihood of cancer recurrence using the expression profile of these biomarkers. The ColoNode kit's ability to analyze up to 100% of the lymph node volume offers a more comprehensive foundation for making decisions regarding staging, adjuvant chemotherapy treatment, and follow-up. In comparison to the standard histopathology method, ColoNode is a more sensitive technique with the potential to enhance staging and provide information on tumor aggressiveness.

HiloProbe has partnered with Biocartis Group NV (Mechelen, Belgium) to commercialize ColoNode, which will be distributed as a manual kit by Biocartis to specialized laboratories in select European countries. Initially, the collaboration will concentrate on marketing the ColoNode CE-marked IVD manual kit in chosen European nations through Biocartis. If the manual kit gains commercial traction, HiloProbe and Biocartis will explore the development of a fully automated test version for Biocartis' decentralized Idylla platform. The Idylla platform is an entirely automated sample-to-result, real-time PCR (Polymerase Chain Reaction) based system that aims to provide on-site access to precise molecular data in minimal time, enabling quicker, more informed treatment decisions.

“We are very happy to start a collaboration and a long-term relationship with Biocartis, which strengthens our focus on colorectal cancer thanks to Biocartis’ established sales and distribution network across many countries,” said Lina Olsson, Chief Executive Officer of HiloProbe. “Further development of a fully automated version of ColoNode on the Idylla platform also holds great potential for ColoNode to contribute faster and more easily to the safer selection of patients who could benefit from postoperative adjuvant treatment.”

“We are pleased to partner with HiloProbe on the distribution of the ColoNode kit,” added Roger Moody, Chief Executive Officer of Biocartis. “This allows us to broaden our product offering to customers in the colorectal cancer domain, complementing tests for RAS biomarkers and MSI on our Idylla platform. The collaboration supports our mission to maximize patient access to precision medicine in oncology.”

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