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New study confirms HiloProbe’s ColoNode kit

The results of a prospective multicenter study conducted in collaboration with Umeå University and eight Swedish hospitals have been published in the International Journal of Cancer.

The study shows that HiloProbe’s ColoNode kit can identify more patients at risk of tumor recurrence following surgery compared to today’s standard method, states the company.

“ColoNode can both help more patients with colorectal cancer survive and avoid overtreatment. This is the strongest supporting evidence for ColoNode to date and shows that it can be of vital use in the future,” says Lina Olsson, CEO of HiloProbe.

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About the study

ColoNode was compared with the current standard method used for lymph node analysis in a multicenter study. Both methods examine whether the tumor cells have spread to lymph nodes in the vicinity of the tumor. This is important to determine, as lymph nodes harboring tumor cells are the strongest indicator we currently have that a patient has not been cured by surgery alone but requires postoperative treatment, such as cytostatics.

The current standard method for lymph node analysis utilizes light microscopy of a few thin hematoxylin and eosin-stained sections of lymph node tissue. ColoNode measures a selected set of biomarkers in lymph nodes from patients who have undergone surgery for colon or rectal cancer by molecular technology, RT-PCR, and employs a proprietary web-based software that calculates the levels and allocates the patient to a certain risk group. ColoNode examines whether the tumor has spread to the lymph nodes and whether there is a risk of tumor recurrence.

Waited three years for follow-up data

The biggest advantages of the ColoNode test are that a much larger lymph node sample (up to and including the entire gland) can be analyzed and that the test can also reveal the degree of aggressiveness of detected tumor cells, something that is impossible with the current standard method. As a result, any decision about possible postoperative treatment using cytostatics can be made with a greater degree of certainty, reducing the risk of undertreatment as well as overtreatment.

“In the study, the lymph nodes collected for analysis were divided in the hospitals so that one lymph node half was analyzed with our ColoNode kit, and the other half analyzed using the current standard method. We then waited three years for follow-up data for relapse, reconciled the results from both methods, and finally compared ColoNode with other risk factors that also need to be considered today,” says Lina Olsson.

Results

The results of the study showed that ColoNode detected all patients identified by the current standard method, plus an additional nine patients. This meant that 25% of the patients who had tumor recurrence were identified by the ColoNode kit alone. Multivariate analysis found that ColoNode was superior to the standard method. It also showed that patients with a tumor that had spread could be allocated into groups with, low, medium, high, and very high risk of tumor recurrence based on ColoNode’s classification of the aggressiveness of the tumor cells.

“This shows that ColoNode can contribute to improving diagnostics for colorectal cancer patients, leading to the detection of more people in need of life-changing additional treatment to surgery. Moreover, some patients can be spared unnecessary additional treatment,” says Lina Olsson.

These latest results strengthen and extend the results from two previous clinical studies.

In May, HiloProbe signed an agreement with the Belgian-based molecular diagnostics company Biocartis to distribute ColoNode in several European markets. The results from this latest study will further assist HiloProbe in its mission to establish its innovative product in Europe, it states.

The company is currently responsible for direct sales in the Nordic countries, while sales in several selected countries in Europe will take place in collaboration with Biocartis.

Photo of the HiloProbe team