Natera has filed a patent for a method to determine the status of an allograft in a transplant recipient using genotypic data from a mixed DNA sample. The method involves preferentially enriching the DNA sample at polymorphic loci to minimize allelic bias. The patent also includes a method to prepare amplified DNA from a blood sample for quantifying the amount of donor-derived cell-free DNA. 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 September 2023 was 35%. Grant share is based on the ratio of number of grants to total number of patents.
A method for quantifying donor-derived cell-free dna in a transplant recipient's blood sample
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A recently filed patent (Publication Number: US20230287497A1) describes a method for preparing a preparation of amplified DNA derived from a blood sample of a transplant recipient. This method is useful for quantifying the amount of donor-derived cell-free DNA (dd-cfDNA). The method involves several steps, including extracting DNA from the blood sample, performing targeted amplification at 200-50,000 target loci using 200-50,000 primer pairs, and analyzing the amplified DNA to quantify the amount of donor-derived cell-free DNA.
In one embodiment of the method, size selection is performed during the DNA extraction step to enrich for donor-derived cell-free DNA and reduce the amount of recipient-derived cell-free DNA. Additionally, in another embodiment, high-throughput sequencing is used to sequence the amplification products and obtain sequence reads, which are then used to quantify the amount of donor-derived cell-free DNA.
The method also includes the option of performing universal amplification of the extracted DNA.
The method is applicable to transplant recipients who have received various types of transplants, including organ transplants, tissue transplants, cell transplants, and fluid transplants. The specific types of transplants mentioned in the patent include kidney, liver, pancreas, intestinal, heart, lung, heart/lung, stomach, testis, penis, ovary, uterus, thymus, face, hand, leg, bone, bone marrow, cornea, skin, pancreas islet cell, heart valve, blood vessel, and blood transfusion.
The quantification of the amount of donor-derived cell-free DNA can be done by determining the percentage of donor-derived cell-free DNA out of the total DNA in the blood sample or by determining the number of copies of donor-derived cell-free DNA per volume unit of the blood sample. The method also takes into account the body mass or blood volume of the transplant recipient during the quantification step.
Furthermore, the patent claims that the method can be used to detect the occurrence or likely occurrence of active rejection of transplantation by analyzing the quantified amount of donor-derived cell-free DNA. The method does not require prior knowledge of donor genotypes.
The patent also describes the amplification of polymorphic loci and non-polymorphic loci in a single reaction and the measurement of alleles at the target loci that are polymorphic.
The determination that the percentage or amount of donor-derived cell-free DNA is above a cutoff threshold is indicative of acute rejection of the transplant. The cutoff threshold value can be expressed as a percentage of donor-derived cell-free DNA in the blood sample or as a copy number of donor-derived cell-free DNA per volume unit of the blood sample, scaled according to the amount of total cell-free DNA. The method can be calibrated according to the amount of total cell-free DNA in the blood sample.
The patent claims that the method has a sensitivity of at least 80% and a specificity of at least 70% in identifying acute rejection over non-acute rejection when the amount of donor-derived cell-free DNA is above the cutoff threshold value scaled according to the amount of total cell-free DNA in the blood sample.
Overall, this patent describes a method for preparing and analyzing amplified DNA from a blood sample of a transplant recipient to quantify the amount of donor-derived cell-free DNA. The method has potential applications in detecting acute rejection of transplants.
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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
