Diagnostic Test for Identifying the Origin of the Tumor

Canhelp-Origin Utility

Canhelp-Origin is a molecular test used on FFPE tumor tissue samples to identify the primary site of a metastatic tumor, particularly useful in poorly differentiated or undifferentiated tumors, for which the origin is unknown, such as in tumors classified as CUP (Carcinoma of Unknown Primary).
Canhelp-Origin uses quantitative RT-PCR technology and has been clinically validated, with overall accuracy superior to 90% in identifying primary sites of metastatic tumors.
The test evaluates the expression of 90 genes specific to 21 tumors and covers over 95% of solid tumors by incidence worldwide.

Intended uses

For the molecular pathologist, the use of the kit is indicated in the following cases:

• the tumor is poorly differentiated or undifferentiated
• the sample is of compact size and this limits the diagnostic process
• the IHC results are inconclusive or contradict previous results
• And impossible to diagnose differentially two or more types of tumors

For the oncologist, the kit is used when:

• the patient has a history of multiple tumors
• we are in the presence of atypical metastatic sites
• the diagnosis clinical and pathological are discordant
• there is a doubt about the diagnosis after a therapeutic failure

Canhelp-Origin is a CE IVD certified kit

Canhelp-Origin is performed on FFPE tumor tissue samples (from poorly differentiated, undifferentiated and metastatic tumors) directly in the laboratory.

The test analyzes the expression pattern of 90 genes from RNA extracted from FFPE samples via RT-qPCR and calculates similarity scores for each of the 21 tumor types investigated.

Each Canhelp-Origin kit contains materials and reagents for 10 tests.

Sensitivity and specificity

Clinical studies have shown a high sensitivity and specificity of the test, as well as its efficacy in guiding treatment and improving survival in patients with carcinoma of unknown origin.

Procedure

The procedure for running the Canhelp-Origin test involves the following steps:

The data obtained from the PCR are analyzed by the Canhelp™-Origin Software (CE-IVD) to determine the similarity between the sample's gene profile and the profiles of 21 tumors.

The Canhelp-Origin report

The report provides a ranking of the 21 most common tumor types, indicating for each a similarity score that represents the probability that the tumor originates from that specific tissue. In the example below, the highest score is associated with breast cancer, which suggests that the tumor may originate in the breast.
For each tumor type analyzed, the report provides a similarity score ranging from 0 to 100. The total sum of the scores is 100, and a tumor type with a score higher than 45.3 is the most likely site of origin of the tumor.

Bibliography

Canhelp-Origin has been validated on more than 3000 cancer patients and more than 18 scientific articles have been published.

Liu, Xin et al., The Lancet Oncology, 2024

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