Press release Biocartis Group NV

Biocartis and HiloProbe to Collaborate on Colorectal Cancer Test

PRESS RELEASE: 9 May 2023, 07:00 CEST

Biocartis and HiloProbe to Collaborate on Colorectal Cancer Test

Mechelen, Belgium, 9 May 2023 - Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), and HiloProbe, a Umeå (Sweden) based biotechnology company focused on personalizing colorectal cancer diagnostics, today announce that they entered into a collaboration that will initially focus on the commercialization of ColoNode, a CE-marked IVD gene expression signature test that can help detect nodal metastasis in colorectal cancer (CRC) patients. ColoNode will be distributed as a manual kit by Biocartis to expert laboratories in selected European countries.

CRC is the third most common cancer type in the world with an estimated 1.9 million new cases and 0.9 million deaths per year worldwide¹. 70-90% of CRC patients may undergo surgical resection of the tumor. International guidelines² have introduced the tumor-node-metastasis (TNM) staging system, that assesses primary tumor (T), lymph node metastasis (N), and distant metastasis (M) to predict disease recurrence and survival. As a key component in this staging system, lymph nodes that are contained in the resected section of the colon, are inspected for presence of disseminated tumor cells. Lymph node status is also a key factor in deciding on post-operative adjuvant chemotherapy. The routine method of determining lymph node status (pN) is microscopic examination of H&E³ stained lymph node tissue sections, that has limitations: it is insensitive and subjective, requires specially trained pathologists, examines < 1% of the lymph node volume and cannot differentiate between aggressive and relatively harmless tumor cells.

ColoNode is a CE-marked IVD gene expression test that detects and characterizes tumor cells in post-operative CRC lymph node samples. The ColoNode kit can analyze up to 100% of the lymph node volume and is more sensitive in detecting tumor cells than H&E staining. Additionally, the test provides an estimation of the risk of CRC recurrence based on the tumor aggressiveness markers included in the ColoNode kit⁴.

The partnership will initially focus on the commercialization of the ColoNode CE-marked IVD manual kit in selected European countries by Biocartis. Following commercial uptake of the manual kit, HiloProbe and Biocartis will consider developing a fully automated version of the test on Biocartis’ decentralized Idylla platform.