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US 2025/0084487 A1Published application
Fecal sample processing and analysis comprising detection of blood
AssigneeExact Sciences Corporation
InventorJoost Louwagie
Life of this patent
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Abstract
Methods and kits directed to processing a fresh fecal sample from a human subject by a process comprising removing a portion of a collected fecal sample and adding the removed portion of the sample to a buffer that prevents denaturation or degradation of blood proteins, and stabilizing the remaining portion of the fecal sample with a stabilizing buffer that maintains nucleic acid integrity.
Claims30
A method of testing a human subject undergoing routine examination for presence of a colorectal malignancy and/or pre-malignancy, comprising:
- a) providing the subject with a kit for collection of a pair of fecal portions from a fecal sample at home by the subject, the kit comprising:
- i) a sealable vessel for collection of the fecal sample, the sealable vessel configured for a human subject to directly defecate into the sealable vessel;
- ii) a sealable container for receiving a removed portion of the fecal sample, containing therein a buffer solution that inhibits denaturation or degradation of blood proteins;
- and
- iii) a stabilizing buffer for maintaining nucleic acid integrity;
- wherein the subject prepares a pair of fecal portions by processing a freshly-defecated fecal sample without freezing by a method comprising:
- (1) defecating directly into the sealable vessel to produce the fecal sample;
- (2) removing a portion of the fecal sample to produce a removed portion and a remaining portion, wherein the removing comprises using a collection device provided with the sealable container to remove the removed portion to the sealable container and sealing the sealable container;
- and
- (3) combining the remaining portion of the fecal sample in the sealable vessel with the stabilizing buffer and sealing the sealable vessel;
- b) receiving the pair of fecal portions from the subject;
- c) immunochemically testing the removed portion of the fecal sample using anti-hemoglobin antibodies to determine a concentration of hemoglobin, wherein a concentration of hemoglobin in the removed portion is indicative that the fecal sample is positive for presence of blood;
- and
- d) if the concentration of hemoglobin determined in c) does not indicate that the fecal sample is positive for the presence of blood, detecting human nucleic acid from the remaining portion of the fecal sample using polymerase chain reaction (PCR) with a fluorophore-labeled probe.
11 more elements
A method of testing a human subject undergoing routine examination for presence of a colorectal malignancy and/or pre-malignancy, comprising:
- a) receiving a pair of fecal portions prepared by the subject by processing a freshly-defecated fecal sample without freezing using a kit, the kit comprising:
- i) a sealable vessel for collection of the fecal sample, the sealable vessel configured for a human subject to directly defecate into the sealable vessel;
- ii) a sealable container for receiving a removed portion of the fecal sample, containing therein a buffer solution that inhibits denaturation or degradation of blood proteins;
- and
- iii) a stabilizing buffer for maintaining nucleic acid integrity;
- wherein the pair of fecal portions are prepared by a method comprising:
- (1) defecating directly into the sealable vessel to produce the fecal sample;
- (2) removing a portion of the fecal sample to produce a removed portion and a remaining portion, wherein the removing comprises using a collection device provided with the sealable container to remove the removed portion to the sealable container and sealing the sealable container;
- and
- (3) combining the remaining portion of the fecal sample in the sealable vessel with the stabilizing buffer and sealing the sealable vessel;
- b) immunochemically testing the removed portion of the fecal sample using anti-hemoglobin antibodies to determine a concentration of hemoglobin, wherein a concentration of hemoglobin in the removed portion is indicative that the fecal sample is positive for presence of blood;
- and
- c) if the concentration of hemoglobin determined in b) does not indicate that the fecal sample is positive for the presence of blood, detecting human nucleic acid from the remaining portion of the fecal sample using polymerase chain reaction (PCR) with a fluorophore-labeled probe.
10 more elements
Dependencies are inferred from the claim text.