New Distribution Agreement Expands Access to CE-Marked Precision Oncology Assays

The agreement extends distribution to France, Germany, the United Kingdom, Austria, Switzerland, and the Benelux region. It builds on the companies’ existing partnership in Italy to strengthen access to precision oncology testing.

Canhelp‑UCa is a CE‑marked IVD molecular assay developed for the noninvasive detection and recurrence monitoring of urothelial carcinoma of the bladder and upper urinary tract. The test analyzes an eight‑gene RNA signature from a urine sample to deliver molecular insights without invasive procedures. It is intended to support early detection in symptomatic patients and ongoing disease monitoring, helping reduce diagnostic uncertainty and enable timely clinical decisions.

Urothelial carcinoma is characterized by high recurrence rates and a significant burden of surveillance, often requiring repeated cystoscopies that can be uncomfortable and stressful for patients. In this setting, the UCa test provides a powerful complementary approach by enabling reliable detection through a convenient, non-invasive sample.

Canhelp‑Origin is a CE‑marked IVD assay for patients with cancer of unknown or uncertain primary, where standard evaluations cannot determine the site of origin. Using tumor tissue, the assay measures expression of 90 genes to generate a molecular profile that is compared with a reference database covering 21 tumor types to predict the most likely tissue of origin. By providing a data‑driven origin prediction, the test supports more targeted, site‑specific therapeutic decision‑making in complex metastatic presentations.

Cancer of unknown or uncertain primary is clinically challenging and can lead to empirical treatment approaches and poor prognosis. By providing a data-driven prediction of tumor origin, the Canhelp-Origin test helps clinicians move toward more targeted, site-specific therapies, even in complex metastatic cases where conventional diagnostics fail to identify the primary tumor. By reducing diagnostic uncertainty, the test supports more confident decision-making and a more personalized approach to cancer care.

Both assays are built on reverse transcription quantitative polymerase chain reaction (RT‑qPCR) technology for use on established laboratory platforms. They are compatible with the QuantStudio 5 Dx Real‑Time PCR system, the Applied Biosystems 7500 Real‑Time PCR system, and other RT‑qPCR instruments. The tests are designed for decentralized use, enabling testing closer to patients and supporting faster clinical decision‑making.

“We are delighted to partner with Canhelp Genomics to bring their advanced molecular diagnostic solutions to our markets,” said Denis Fortier, CEO of Eurobio Scientific. “These tests complement our existing oncology portfolio and support clinicians in making informed, precision-based treatment decisions.”

“The partnership with Eurobio Scientific is a defining moment in our mission to make precision oncology accessible to patients worldwide,” stated Dr. Qinghua Xu, CEO of Canhelp Genomics. “Eurobio Scientific’s proven expertise in molecular diagnostics commercialization and their extensive European network make them the ideal partner to bring our solutions to the clinicians and patients who need them most.”

Related Links
Eurobio Scientific
Canhelp Genomics