High Sensitivity Liquid Biopsy Monitoring and Prognosis of Cancer Using Nanodroplet Analysis of Circulating DNA

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This project aims to bring methods, which have achieved proof of concept in breast cancer, towards commercialisation by performing further lab testing and verification in large patient cohorts.

There is an urgent need for improved biomarkers to determine the disease state in cancer patients. Too often, patients are over treated, or conversely, metastatic spread is detected too late for a cure. Today´s imaging methods and protein diagnostics lack the sensitivity and specificity for clinical monitoring. The Saal group at Lund University has developed two innovations, KROMA and IBSAFE, which quantify circulating tumour DNA (ctDNA) from simple blood samples. The methods utilize droplet digital PCR technology and have exquisite accuracy and can give a read-out of the cancer state, whether it is growing/shrinking, has acquired resistance mutations, or has been eradicated.

In this project we aim to bring these methods, which have achieved proof of concept in breast cancer, towards commercialisation by performing further lab testing and verification in very large patient cohorts. This is a collaboration with Bio-Rad Laboratories, a leader in clinical diagnostics and droplet digital PCR instruments, as well as with the Dept. of Clinical Oncology, Skåne University Hospital, Region Skåne, from healthcare. We also aim to test the methods in blood samples from patients with a variety of cancer forms. We will improve the analytical pipeline for improved scalability, and will seek intellectual property protection for our inventive solutions.

Our methods could be used in the future to steer therapy, detect occult metastatic disease at the earliest moment, and spare cured patients the unnecessary side effects of powerful anti-cancer agents. By the end of this project, our innovations will be investable and we will pursue commercialisation.

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Circulating tumor DNA is released by cancer cells into the blood stream. The circulating DNA contains tumor-specific mutations and chromosomal rearrangements that can be detected by the IBSAFE and KROMA methods. Illustration for Lao Saal by EMBO Molecular Medicine.

ABOUT THE PROJECT

Project leader Lao Saal, Lund University lao.saal@med.lu.se
Funding from SWElife 2 000 000 SEK
Call for proposal SWElife spring 2015 call, for proposals for collaborative innovation projects within non-communicable diseases
About the project at Vinnova (in Swedish)