Guardant Health has been granted a patent for a system and method to detect rare mutations and copy number variations in cell-free polynucleotides. The method involves sample preparation, sequencing of the polynucleotides, and the use of bioinformatics tools to detect mutations and variations. The patent also includes a database of different disease profiles to aid in detection. GlobalData’s report on Guardant Health gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on Guardant Health, Personalized medicine biomarkers was a key innovation area identified from patents. Guardant Health's grant share as of September 2023 was 26%. Grant share is based on the ratio of number of grants to total number of patents.

Method for determining methylation profiles of cell-free nucleic acid molecules

Source: United States Patent and Trademark Office (USPTO). Credit: Guardant Health Inc

A recently granted patent (Publication Number: US11773453B2) describes a method for determining methylation profiles of cell-free nucleic acid molecules. The method involves several steps, including converting the nucleic acid molecules into tagged parent polynucleotides, amplifying the tagged parent polynucleotides, enriching them for genomic regions of interest, sequencing the enriched polynucleotides, mapping the sequencing reads to a reference sequence, grouping the mapped reads into families using molecular barcodes, collapsing the sequencing reads within each family to generate consensus sequences, and analyzing these consensus sequences using bioinformatics processes to determine methylation profiles.

The patent claims that the method can be applied to various samples, including blood, plasma, serum, urine, saliva, mucosal excretions, sputum, stool, and tears. The sample should contain between 1 nanogram (ng) and 100 ng of cell-free nucleic acid. The method can handle a wide range of initial starting genetic material, from 100 to 100,000 haploid human genome equivalents of cell-free nucleic acid.

The enzymatic ligation step in the method can be performed using blunt-end ligation or sticky-end ligation. The method utilizes n different molecular barcodes, where n is at least 2 and no more than 10,000*z, with z being the mean of an expected number of duplicate molecules in the polynucleotides. The number of molecular barcodes used is specified to be no more than 1,000*z or no more than 100*z.

The method also includes the enrichment of genomic regions of interest, which can comprise sequences of genes, oncogenes, tumor suppressor genes, promoters, or regulatory sequence elements. The patent claims that the method can be used for detecting cancer in a subject based on the methylation profile determined from the sequencing reads. It can also identify somatic genetic variants, such as single nucleotide variants (SNVs), insertions or deletions (indels), copy number variations (CNVs), or gene fusions. The presence of these somatic genetic variants can be used for detecting cancer in the subject.

Overall, this granted patent describes a method for determining methylation profiles of cell-free nucleic acid molecules, which can be applied to various samples and has potential applications in cancer detection and identification of genetic variants associated with cancer.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies across the world’s largest industries.