New diagnostic method

The invention relates to a method for diagnosis of colorectal cancer from blood sample and a kit realizing the analysis.

Title of the patent New diagnostic method and kit
Thematic area Chemistry and biotechnology
Ownership Alma Mater Studiorum - University of Bologna
Inventors Rossella Solmi, Gabriella Mattei, Giampaolo Ugolini, Maria Teresa Rodia, Mattia Lauriola, Isacco Montroni
Protection Europe, USA
Licensing status Available for licensing agreement
Keywords Colorectal cancer, screening, blood, RNA markers, transcriptome Mapper (TRAM), quantitative Real Time Polimerase Chain reaction (RT-qPCR)
Filed on May 21, 2015

Colorectal cancer (CRC) is the third most common cancer in the world, with nearly 1.4 million new cases detected in 2012. A better survival rate of about five-year is achieved if the primary tumor is detected when still in situ.

Since CRC develops in a multistep process starting with benign precancerous adenomas to aggressive metastatic carcinoma, this progression window makes CRC suitable to early detection in order to contribute to a better outcome.

Multiple screening modalities have been investigated, included fecal tests that detect the presence of haem or blood in stool.

Currently, the principal trends of research of mRNAs candidate markers generally concern on several types of experimental evidences: circulating tumor cells (CTC), cancer stem cells (CSC) and circulating free RNA (cfRNA). The metastatic spread occurs very early in the tumor development, hence a specific and sensitive detection of CTC became crucial for a proper diagnosis.

Our research argue that a test on the whole blood without any attempt to isolate CTCs or CSCs or any blood fraction is much more simple to conduct, in the perspective of a wide use in oncology wards, and it is not affected by loss of CTCs or CSCs, whose number is critical for the success of the test, during purification. The presence of CRC could be detected by specific changes in mRNA expression levels. The targeting of RNA makes is based on the knowledge that tumour phenotypic variation is associated with changes in the mRNA levels of genes regulating or effecting this variation. This has led to the widespread use of real-time reverse transcription polymerase chain reaction (RT-PCR) assays in clinical diagnostics.

A whole blood screening test is crucial to improve colorectal cancer screening.

The sensitivity and specificity of our new panel of markers are very promising.

The blood test is simpler, better accepted than faecal test and colonoscopy and it could be very useful and cheaper for the therapeutic approach.