Pooled Duplex Sequencing for Rare Variant Genotyping

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Solution Overview

Problem

Current next-generation sequencing technologies face challenges in cost-effectively multiplexing small sequencing needs across large numbers of samples, particularly for applications involving rare genetic variants, due to high costs and inefficiencies in sample preparation and indexing for pooled sequencing.

Innovation Solution

The method employs Duplex Sequencing to generate error-corrected sequence reads by ligating adapter molecules to double-stranded DNA molecules, sequencing both strands, and comparing them to identify variant alleles within pooled samples, allowing for efficient and accurate genotyping of multiple samples using unique sub-pools.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If individual indexing and library preparation is performed for each sample, then sample identification accuracy is improved, but preparation cost and time increase significantly

Engineering Contradiction:
Improvesample identification accuracyVSAvoidpreparation efficiency
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The method segments samples into pooled groups and uses combinatorial indexing where each sample is represented by a unique combination of pool identifiers rather than individual sample identifiers. This segmentation allows multiplexed processing while maintaining traceability through the pooling matrix.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces pooled samples as an intermediary layer between individual samples and sequencing. Each pooled sample contains multiple individual samples with unique combinations of pool identifiers, acting as a mediator that enables batch processing while preserving individual sample identification capability.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If pooled sequencing is used to increase throughput, then productivity is improved, but measurement precision of variant detection decreases

Engineering Contradiction:
Improvesequencing throughputVSAvoidvariant detection accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The method performs preliminary error correction by comparing forward and reverse strand sequences before final variant calling. This preliminary action removes sequencing errors and artifacts that would otherwise compromise variant detection accuracy in pooled samples.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements feedback through iterative error correction where sequence reads are compared against reference genomes and error patterns are identified and corrected. The system uses the information from both strands to feedback and refine the accuracy of variant detection.

Inventive Principle:
Principle #23Feedback

3Measurement precision

If extensive library preparation is performed for high accuracy sequencing, then measurement precision is improved, but loss of time increases

Engineering Contradiction:
Improvesequencing accuracyVSAvoidpreparation time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The method merges multiple samples into pooled groups that share common library preparation steps. By combining samples in pools and using combinatorial indexing, the protocol performs library preparation once per pool rather than once per sample, significantly reducing total preparation time while maintaining accuracy through subsequent error correction.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

Error correction and quality control steps are performed as preliminary actions during the library preparation and sequencing process itself, rather than requiring extensive post-sequencing analysis. This preliminary error correction reduces the need for time-consuming follow-up validation.

Inventive Principle:
Principle #10Preliminary action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This approach enables cost-effective and time-efficient genotyping of large numbers of samples with high sensitivity, maintaining original source identification and allowing for the detection of rare variant alleles with high confidence, suitable for pre-clinical and clinical disease assessment and screening.

Implementation Method 1

ligating adapter molecules to the plurality of target double-stranded DNA molecules to generate a plurality of adapter-DNA molecules

Methodology Applied
Scientific EffectLigation:

Implementation Method 2

sequencing one or more copies of the original first and second strands to provide a first strand sequence and a second strand sequence

Methodology Applied
Scientific EffectDNA Sequencing:

Implementation Method 3

comparing the first strand sequence and the second strand sequence to identify one or more correspondences between the first and second strand sequences

Methodology Applied
Scientific EffectSequence Comparison:

Data Source

PatentEP3867397B1Methods and reagents for efficient genotyping of large numbers of samples via pooling
Publication Date: 2026.01.14 TWINSTRAND BIOSCIENCES INC
  • EP3867397B1 patent drawingFigure 1A
  • EP3867397B1 patent drawingFigure 1B~1C
  • EP3867397B1 patent drawingFigure 2

AI summary

Methods and associated reagents for efficient genotyping of large numbers of samples via pooling are disclosed herein. Some of the embodiments of the technology are directed utilizing Duplex Sequencing for efficient genotyping of large numbers of samples (e.g., nucleic acid samples, patient samples, tissue samples, blood samples, etc.) and associated applications. Various aspects of the present technology have many applications in both pre-clinical and clinical disease assessment, screening large sample numbers where relatively infrequent variants are being sought, and others.