Swedish biotech company HiloProbe says it has reached a significant milestone after the results of a prospective multicenter study conducted in collaboration with Umeå University and eight Swedish hospitals were published in the International Journal of Cancer.
The study results show that HiloProbe’s ColoNode kit can identify more patients at risk of tumor recurrence following surgery compared to the standard method used today.
“This means more patients who need additional treatment will receive it, which in turn reduces the risk of tumor recurrence. This is the strongest supporting evidence for our product ColoNode to date and shows that it can be of vital use in the future”, says Lina Olsson, CEO of the Umeå-based company.
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 is 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 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 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. 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 awaited 3 years 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”, explains Lina Olsson.
The study shows that ColoNode detected all the 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. Finally, the study revealed 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. These latest results strengthen and extend the results from two previous clinical studies.
“It feels incredibly rewarding as well as a very important step forward that this study has been completed and the results have turned out to be so promising. Now we can present and share these results with all our stakeholders”, says Lina Olsson.
Improved sensitivity and specificity of tumor cell detection and grading of the aggressiveness of tumor cells in the lymph nodes can lead to fewer patients having a relapse. Using ColoNode can contribute to increased survival rates and improve the quality of life for patients by, for example, sparing some of them from undergoing unnecessary additional treatments that may cause unwanted side effects.
HiloProbe signed an agreement in May with the Belgian-based molecular diagnostics company Biocartis to distribute ColoNode in a number of European markets. The impressive results from this latest study will further assist HiloProbe in its mission to establish its innovative product in Europe. 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.
To read the article published by the International Journal of Cancer, visit http://doi.org/10.1002/ijc.34718