Ulf Bech Christensen, Rasmus Koefoed Petersen
Personalized administration of present and future targeted cancer therapies demands fast, low cost and easy-to-use companion diagnostics (CDx) providing doctors and patients with the answers they need to maximize treatment efficiency and minimize treatment costs. We have developed and clinically validated several real-time PCR based assay for liquid biopsies. Sensitivity studies show that our SensiScreen® Liquid assays can detect down to a single copy of mutated DNA in a background of wild type plasma cell-free DNA (cfDNA) in a simple and robust workflow.
The extreme sensitivity of our assays is obtained by use of BaseBlockers™, that suppress amplification of wild type DNA while allowing amplification of mutated DNA, modified primers and sensitive dual-labelled Probes. BaseBlockers™, primers and probes are all based on the DNA platform technology – Intercalating Nucleic Acid, INA®.
We will present a case study using our SensiScreen® Liquid CE IVD Assay for monitoring disease progression and treatment efficiency in a clinical setting, in a BRAF V600E mutated metastatic colorectal cancer patient. After initial diagnosis and genotyping, we have monitored the patient’s cfDNA levels and the cfDNA amount of BRAF V600E in plasma for more than 700 days during three different regimes of treatment and compared with carcinoembryonic antigen and CA 19-9 levels.
We believe that sensitive monitoring of liquid-based biopsies present unique opportunities for healthcare providers, targeted therapy developers, and eventually cancer patients. The information and additional knowledge gained on patient response and efficacy of treatment can be used as a tool to reduce use of inefficient treatment and improve clinical output.
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