HLA Haplotype Determination via Segmented PCR and Computational Phasing

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Solution Overview

Problem

Current DNA-based technologies for HLA typing face challenges such as limited read lengths in sequencing, the need for cloning haplotypes separately, and high error rates, which hinder accurate determination of HLA haplotypes.

Innovation Solution

The method involves selectively amplifying nucleic acid molecules, particularly exons and adjacent introns of HLA genes, and using paired-end sequencing to obtain non-overlapping sequencing reads. These reads are then partitioned using algorithms like k-means clustering to determine haplotypes accurately.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Length of moving object

If traditional sequencing technologies are used for HLA typing, then sequencing can be performed, but read lengths are insufficient to sequence both exons together and cloning is required separately

Engineering Contradiction:
Improveread lengthVSAvoidcloning process complexity
Core Design Contradiction:
Length of moving objectVSDevice complexity

Solution Approach 1:

The invention divides the HLA gene region into two segments: exon 2 and exon 3. By designing separate PCR amplification reactions for each exon, the method enables sequencing of individual exons with standard read lengths, avoiding the need for long-read sequencing or cloning while still allowing haplotype determination through computational phasing of the segmented data.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention transitions from a single-dimension approach (attempting to sequence the entire exon 2-exon 3 region in one read) to a multi-dimensional approach by performing separate amplifications and sequencing for each exon, then combining the information computationally. This dimensional shift allows standard sequencing technologies to achieve what would otherwise require advanced sequencing capabilities.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Measurement precision

If sequencing based typing is performed to provide higher information content, then typing ambiguities are avoided, but high error rates are associated with sequencing technologies

Engineering Contradiction:
Improvetyping accuracyVSAvoidsequencing error rate
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The invention implements a feedback mechanism through iterative computational analysis. Sequencing reads are initially assigned to haplotypes based on sequence similarity, then consensus sequences are generated from assigned reads, and this process repeats iteratively. Each iteration refines the haplotype assignments by comparing new reads against updated consensus sequences, allowing error correction through cumulative evidence and statistical phasing algorithms that leverage linkage disequilibrium patterns.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The invention creates multiple copies of sequencing reads through PCR amplification and generates redundant sequencing data by sequencing both exons separately. This redundancy allows computational algorithms to identify and correct sequencing errors by comparing multiple reads against each other and against reference haplotype patterns, thereby improving reliability despite inherent sequencing error rates.

Inventive Principle:
Principle #26Copying

3Loss of information

If complete sequencing of both exons together is attempted, then direct haplotype information is obtained, but read lengths required are not available with current technologies

Engineering Contradiction:
Improvephase informationVSAvoidread length
Core Design Contradiction:
Loss of informationVSLength of moving object

Solution Approach 1:

The invention performs preliminary action by separately amplifying and sequencing exon 2 and exon 3 before computational combination. By obtaining sequence data for each exon independently with standard read lengths, the method preserves phase information through statistical phasing algorithms that analyze linkage disequilibrium patterns, avoiding the need for physical long-read sequencing while still recovering complete haplotype information.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP3594362B1Method and systems for determining haplotypes in a sample
Publication Date: 2025.06.11 ILLUMINA INC
  • EP3594362B1 patent drawingFigure 1
  • EP3594362B1 patent drawingFigure 2A~2B
  • EP3594362B1 patent drawingFigure 2C

AI summary

Presented herein are methods and compositions for determining haplotypes in a sample. The methods are useful for obtaining sequence information regarding, for example, HLA type and haplotype. Also presented herein are methods of determining haplotypes in a sample based on a plurality sequence reads.