Natera. has been granted a patent for methods to detect single nucleotide variants in breast, bladder, and colorectal cancers. The invention includes techniques for monitoring early relapse or metastasis through multiplex amplification of patient-specific nucleic acids from blood or urine samples, enhancing minimal residual disease identification. GlobalData’s report on Natera 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 Natera, AI-assisted genome sequencing was a key innovation area identified from patents. Natera's grant share as of June 2024 was 33%. Grant share is based on the ratio of number of grants to total number of patents.
Methods for detecting cancer-related single nucleotide variants
The granted patent US12024738B2 outlines a method for preparing a composition of amplified DNA from plasma samples of breast cancer patients, specifically aimed at identifying single-nucleotide variant loci that indicate minimal residual disease (MRD). The method involves longitudinal collection of plasma samples post-treatment, extraction of cell-free DNA, and performing a multiplex amplification reaction to generate a set of amplicons. Each amplicon targets at least one of a minimum of 16 patient-specific single nucleotide variant loci associated with the cancer, identified from tumor samples. The amplified DNA is then analyzed through high-throughput sequencing, achieving a median depth of read of at least 100,000 per locus. The identification of two or more patient-specific single nucleotide variants above a confidence threshold of 0.97 is indicative of MRD, with a specificity of at least 99.5% for various breast cancer subtypes, including HER2+, triple-negative, and HR+/HER2- cancers.
Further claims detail the method's efficacy, indicating that it can identify patient-specific single nucleotide variants in a significant percentage of patients with MRD—at least 85% overall, and up to 95% for specific subtypes. The method is also capable of detecting MRD well in advance of clinical relapse or metastasis, with timeframes ranging from 150 to 250 days prior to observable changes in imaging or biomarker levels. Importantly, the method demonstrates a high specificity, not identifying variants in at least 99% of patients without MRD. The patent also allows for the selection of 16 to 50 patient-specific loci based on clonal mutations from tumor samples, with the potential for increased sequencing depth to enhance detection accuracy.
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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.
