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Biomarker panel and methods for detecting microsatellite instability in cancers

A technology for biomarkers and biological samples, applied in biochemical equipment and methods, determination/inspection of microorganisms, etc., can solve the problems of repeated scoring of single homopolymers, high cost, low sensitivity, etc.

Active Publication Date: 2020-10-30
拜奥卡蒂斯生物股份有限公司
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Problems solved by technology

With respect to (ii), however, high-resolution melting curve analysis of dsDNA-intercalating dyes has very limited multiplexability to screen for several different MSI markers in a single run, since the melting temperatures of each marker amplicon need to be sufficiently different to no overlapping signals
Furthermore, since this strategy relies on heteroduplex formation between normal and mutant length alleles, it is also less sensitive than other alternatives
Next, regarding (iii), mass spectrometry-based methods (Zhao et al., 2014) are in principle also suitable for automation, but require specialized instruments and highly skilled personnel for data interpretation
Finally, with respect to (iv), NGS certainly has the advantage of looking at a large number of MSI-indicated locations in the genome or exome, not just selectable markers, and although this approach is also in principle at least partially automated, it is currently very Expensive and requires dedicated NGS hardware
Regarding homopolymer scoring, NGS is still insufficient for repeat scoring of individual homopolymer repeats, as it is still prone to losing information about single nucleotide indels in a string of repeat nucleotides
Also, it is still time consuming, complex and requires trained analysts due to the large amount of data generated
[0012] In conclusion, MSI testing represents a high medical need that is only partially met by existing diagnostic methods due to their technical limitations
Importantly, these include limited detection capabilities, high costs and / or turnaround times, requirements for specialized equipment and / or interpretation by trained experts

Method used

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  • Biomarker panel and methods for detecting microsatellite instability in cancers
  • Biomarker panel and methods for detecting microsatellite instability in cancers
  • Biomarker panel and methods for detecting microsatellite instability in cancers

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Embodiment

[0211] 1. Detection of microsatellite instability (microsatellite instability) in cancer samples with a new collection of highly sensitive markers Instability, MSI)

[0212] It is not easy to derive a minimum set of 4 markers from any given set of markers. For example, Zhao et al., 2014, eLife, described Sequenom analysis of 18 MSI-H samples using a panel of 59 markers revealed that the markers were called mutants in an average of 44.26% of the samples. Despite the high performance of this large panel of markers in detecting MSI status, a random set of 4 selected markers derived from it was less effective than the core set including ACRV2A, DIDO1, MRE11, SULF2 proposed here. Theoretical performance is much worse. Such randomly selected panels are additionally susceptible to the disadvantage that they may contain markers that show race-dependent differences in homopolymeric regions, such as that observed for the marker TMEM65 for the Caribbean population. This discrepancy...

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Abstract

The present invention generally relates to the field of cancer, in particular to cancers having microsatellite instability (MSI) and / or mismatch repair (MMR-) deficiency. Examples of such cancers include many colorectal, gastric, and endometrial tumors. Accordingly, the present invention provides a novel diagnostic marker panel for analyzing MSI loci, together with methods and kits of using said panel in the detection of cancers having microsatellite instability (MSI) and / or mismatch repair (MMR-) deficiency.

Description

technical field [0001] The present invention relates generally to the field of cancer, and in particular to cancers with microsatellite instability (MSI) and / or mismatch repair (MMR-) deficiencies. Examples of such cancers include many colorectal, gastric and endometrial tumors. Accordingly, the present invention provides novel diagnostic marker panels for the analysis of the MSI locus, as well as methods of using said panels for the detection of cancers with microsatellite instability (MSI) and / or mismatch repair (MMR-) deficiency. Methods and kits. Background technique [0002] In Europe and the United States, approximately 440,000 patients are diagnosed with colorectal cancer (CRC) each year. Recent guidelines, such as NCCN Guidelines for Patients: Colon Cancer Version 1.2017 and ESMO Clinical Practice Guidelines on familial risk-colorectal cancer, recommend tumor testing for DNA mismatch repair (MMR) deficiency and / or MSI status in all CRC patients. However, these tes...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6886
CPCC12Q1/6886C12Q2600/156
Inventor B·德克拉内K·德坎涅瑞J·万德维尔德G·马尔滕斯
Owner 拜奥卡蒂斯生物股份有限公司
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