公开(公告)号：US20250109441A1

公开(公告)日：2025-04-03

申请号：US18726359

申请日：2023-01-04

Applicant: Natera, Inc.

Inventor： Ekaterina KALASHNIKOVA ,  Hsin-Ta WU ,  Samay MEHTA ,  Raheleh SALARI ,  Bernhard ZIMMERMANN ,  Paul R. BILLINGS ,  Alexey ALESHIN

IPC: C12Q1/6886

Abstract: The invention provides methods for preparing a preparation of amplified DNA derived from a biological sample of a patient who has been diagnosed with cancer useful for determining relapse or metastasis of cancer, comprising (a) sequencing DNA isolated from hematopoiesis cells in a blood or bone marrow sample of the patient or a fraction thereof to determine the presence or absence of one or more clonal hematopoiesis of indeterminate potential (CHIP) mutations; (b) sequencing (i) DNA isolated from a tumor biopsy sample of the patient or (ii) cell-free DNA isolated from the blood or bone marrow sample or a fraction thereof, to identify a plurality of patient-specific somatic mutations associated with the cancer; (c) preparing a preparation of amplified DNA by performing targeted multiplex amplification on cell-free DNA isolated from a longitudinally collected biological sample of the patient or a fraction thereof to amply a plurality of target loci to obtain amplified DNA, wherein each of the target loci spans a patient-specific somatic mutation identified in step (b) and does not span any CHIP mutation identified in step (a), wherein the biological sample is a blood, urine, or bone marrow sample; and (d) analyzing the preparation of amplified DNA by sequencing the amplified DNA to determine the presence or absence of the patient-specific somatic mutations, wherein the presence of two or more patient-specific somatic mutations associated with the cancer and the presence of one or more CHIP mutations are indicative of relapse or metastasis of the cancer.

公开(公告)号：US20220356530A1

公开(公告)日：2022-11-10

申请号：US17725341

申请日：2022-04-20

Applicant: Natera, Inc.

Inventor： Shruti SHARMA ,  Bernhard ZIMMERMANN ,  Himanshu SETHI ,  Alexey ALESHIN ,  Svetlana SHCHEGROVA

IPC: C12Q1/6886

Abstract: The invention provides methods for determining the growth rate of ctDNA, comprising (a) sequencing nucleic acids isolated from a biological sample of a cancer patient to identify patient-specific cancer mutations; (b) quantify the amount of ctDNA in a first liquid biopsy sample collected from the cancer patient by performing a multiplex amplification reaction to amplify target loci from cfDNA isolated from the first liquid biopsy sample, wherein each target locus spans at least one patient-specific cancer mutation, and sequencing the amplified target loci to identify the patient-specific cancer mutations and quantify the amount of ctDNA in the first liquid biopsy sample; (c) quantify the amount of ctDNA in a second liquid biopsy sample collected from the cancer patient by performing a multiplex amplification reaction to amplify target loci from cfDNA isolated from the second liquid biopsy sample, wherein each target locus spans at least one patient-specific cancer mutation, and sequencing the amplified target loci to identify the patient-specific cancer mutations and quantify the amount of ctDNA in the second liquid biopsy sample; and (d) determining the growth rate of the ctDNA between the first and second liquid biopsy samples.