SensiScreen® KRAS exon 2 simplex and multiplex CE-IVD is a novel real-time PCR-based method for KRAS exon 2 mutation detection developed by PentaBase. In a newly published article in PLOS ONE (https://doi.org/10.1371/journal.pone.0178027), we show that the limit of detection of both simplex and multiplex assays fall within the range of just 0.25-1% and that SensiScreen® finds additional mutant positive cases in retrospective analyses of colorectal cancer patient populations compared to the common methods initially used.
The study, which was funded by the Eurostars project “ONSET Diagnostics”, is the result of a collaboration between the Swiss Istituto Cantonale di Patologia (ICP), Aarhus University Hospital, the Danish Technological Institute and PentaBase. The aim of the project was to develop a genetic test with high sensitivity that will help oncologists choose the right type of treatment from the beginning.
Milo Frattini, head of the Laboratory of Molecular Pathology at ICP, elaborates: “While recommendations issued by both the US Food and Drug administration (FDA) and the European Medicines Agency (EMA) mandate mutational testing of KRAS in colorectal cancer patients, there are no specific requirements to the limit of detection of the methods used. Thus, there is still widespread use of methods such as direct sequencing with poor sensitivity towards somatic mutations. The result is that a large group of colorectal cancer patients most likely receives treatments that are inefficient and that may in fact worsen their condition. I hope that our study can be an inspiration to laboratories around the world to choose more sensitive methods for somatic mutation analysis”.
The study also demonstrates the high specificity of SensiScreen® which is a result of the included BaseBlocker™ technology also developed by PentaBase, as Ulf Christensen, CEO of PentaBase, explains: “BaseBlockers are oligonucleotides modified with PentaBase´s nucleotide analogue chemistry that make them able to bind very specifically to their target. By including BaseBlockers in our SensiScreen assays, we demonstrate how PentaBase´s BaseBlocker technology can be a valuable tool when analyzing small amounts of mutated genetic material in a large background of wild type DNA. It really allows us to find the needle in a haystack”.
SensiScreen® KRAS exon 2 simplex and multiplex CE-IVD is a part of a product portfolio of SensiScreen® assays that currently also include mutations in KRAS exon 3 and 4, NRAS, BRAF and EGFR genes. The corresponding assays for liquid biopsies are under development and are expected to be released during second half of 2017.