Dr Rossella Solmi, Alma Mater Studiorum - Università di Bologna; Dr Mattia Lauriola, Alma Mater Studiorum - Università di Bologna; Dr Giampaolo Ugolini, Alma Mater Studiorum - Università di Bologna; Dr Isacco Montroni, Alma Mater Studiorum - Università di Bologna; Dr Maria Teresa Rodia, Alma Mater Studiorum - Università di Bologna; Dr Gabriella Mattei, Alma Mater Studiorum - Università di Bologna
Colorectal cancer is the third most common cancer worldwide, with almost 1.4 million new cases diagnosed in 2012. Early stage detection is a significant factor in obtaining higher patient survival rates. Research in markers as a screening tool in a patient’s blood is an important research topic for early diagnosis in colorectal cancer. There is a need for a simple and reliable test that may be conducted on whole blood, rather than stool (feces) which requires manipulation or extraction processes.
This invention consists of a method and diagnostic kit for the early detection of colorectal cancer. Our studies are based on recent clinical evidence on: 1) first stage carcinomas, when primary tumor size is less than 2 mm, shows active angiogenesis and are therefore able to release circulating tumor cells (CTCs) in peripheral blood, as well as free nucleic acids; 2) tissue-specific mRNA identification, which is also an indirect method for displaying free CTC and free nucleic acids.
Using Reverse Transcription Polymerase Chain Reaction (RT-PCR) detection, a diagnostic mRNA panel markers were found, and demonstrated statistically significant differences in mRNA blood marker concentrations between healthy subjects and individuals with colorectal cancer.
A non-invasive blood test for early detection of colorectal cancer is required and not yet available in the market. Considering the progression from premalignant lesions to carcinoma and metastasis is relatively slow, in some cases taking up to 15 years to progress, this provides a long timeframe for early detection. The incidence of false positive results in faecal immunochemical tests is a significant driver for new non-invasive and more specific screening tests, including blood markers.
Proof-of-concept: tested on more than 200 volunteers and patients.
Patent pending applications in Italy, USA and Europe with priority date on 2015.
Rodia MT, Ugolini G, Mattei G, et al. Systematic large-scale meta-analysis identifies a panel of two mRNAs as blood biomarkers for colorectal cancer detection. Oncotarget. March 2016. doi:10.18632/oncotarget.8108.
Rodia MT, Solmi R, Pasini F, Nardi E, Mattei G, Ugolini G, Ricciardiello L, Strippoli P, Miglio R, Lauriola M. LGALS4, CEACAM6, TSPAN8, and COL1A2: Blood Markers for Colorectal Cancer-Validation in a Cohort of Subjects With Positive Fecal Immunochemical Test Result. Clin Colorectal Cancer. 2017 Dec 12. pii: S1533-0028(17)30380-8. doi: 10.1016/j.clcc.2017.12.002. [Epub ahead of print]