Prof. Michal Holčapek, University of Pardubice, Faculty of Chemical Technology; Dr Robert Jirásko, University of Pardubice, Faculty of Chemical Technology; Dr Denise Wolrab, University of Pardubice, Faculty of Chemical Technology; Dr Eva Cífková, University of Pardubice, Faculty of Chemical Technology
University of Pardubice
Cancer is the first or second leading cause of death in many countries. 18.1 million cancer cases and 9.6 million cancer deaths were estimated worldwide for 2018 (Globocan 2018). Early diagnosis is the most critical issue. Finding cancer early improves the survival rate and treatment options. Faster, economical methods with a limited invasiveness, improved sensitivity and specificity, suitable for routine high-throughput screening are needed. Lipidomic profiling works well for all cancer stages including the earliest stages T1 and T2. Primarily we focus on pancreatic cancer, which belongs among the most lethal tumors with the lowest survival rate of all cancers and is very hard to be diagnosed at early stages.
Lipid profiling of body fluids monitors the comprehensive picture of the whole lipidome instead of one biomarker or panel of few biomarkers. MS based lipidomic analysis key benefits:
- not dependent on cancer stage
- detection of curable early stages T1, T2
- accuracy ≥ 90%
- robust for high-throughput quantitation
- detects even the slightest metabolic differences
- serum / plasma, small sample volume 10-25μl
- standard clinical laboratory equipment
- sample throughput 10,000 samples/year/one MS systém
- cancerous pattern - usually all the detectable lipids, approx.. 400 species
- 4 cancer types studied (pancreatic, kidney, breast, prostate)
- pancreatitis and diabetes samples classified as non-cancerous
The methodology is available for licensing, investment and further development. First investment has been provided by the Czech biotechnological incubator i&i Prague. Beside screening purposes, the new technology could be of great value for the monitoring of patients who have undergone resection and adjuvant chemotherapy treatment. Additionally, it could significantly speed up the correct diagnosis in those patients who are already symptomatic. Since the symptoms of pancreatic cancer tend to be quite non-specific, the disease can take several months with the current methods to diagnose (in one study from the UK, the median time to diagnosis was 117 days) (Walter et al., 2016), which delays treatment and may negatively affect the patient’s prognosis.
The analytical method has been developed in compliance with FDA and EMEA guideline on bioanalytical method validation. The study design and information reporting have been planned in line with MIBBI guidelines and REporting recommendations for tumor MARKer prognostic studies (REMARK). Retrospective clinical studies (looking backward in time by using well defined samples of the known disease) - based on >850 human samples (plasma and serum) of 4 cancer types of stages I-IV and matched healthy controls were run to develop the specific cancerous, specific cancerous and non-cancerous patterns. Further development and validation of OncoLipidimics product for pancreatic cancer has been in progress.
EP applications were filed in January and May 2018. PCT filed on 28 November 2018. FTO analysis has been performed.