Exact Sciences has filed a patent for a method of processing a freshly-collected fecal sample without freezing. The method involves combining different portions of the sample with a stabilizing buffer and a solution to prevent denaturation or degradation of blood proteins. The patent aims to test the nucleic acid extracted from the sample for human nucleic acid and to detect the presence of human blood. GlobalData’s report on Exact Sciences gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on Exact Sciences, Personalized medicine biomarkers was a key innovation area identified from patents. Exact Sciences's grant share as of September 2023 was 43%. Grant share is based on the ratio of number of grants to total number of patents.
A recently filed patent (Publication Number: US20230313317A1) describes a method for processing a freshly-collected fecal sample without the need for freezing. The method involves collecting the fecal sample from a human subject at home and then combining different portions of the sample with specific solutions in sealable vessels and containers.
The first portion of the fecal sample is combined with a stabilizing buffer in a sealable vessel, while the second portion is combined with a solution that prevents denaturation or degradation of blood proteins in a sealable container. Both the sealable vessel and container are then sealed.
The patent also includes a step of delivering the sealable vessel containing the first portion of the fecal sample and the stabilizing buffer, as well as the sealable container containing the second portion of the fecal sample and the solution, to a medical diagnostics laboratory.
In another aspect of the patent, a method is described for processing a fecal sample that has already been collected. This method involves obtaining a pair of portions of the fecal sample, where one portion is stored in a sealed sealable vessel with a stabilizing buffer, and the other portion is stored in a sealed sealable container with a solution that prevents denaturation or degradation of blood proteins.
The method further includes extracting nucleic acid from the first portion of the fecal sample and testing it for the presence of human nucleic acid. The second portion of the fecal sample is tested for the presence of a blood protein.
The patent also describes various techniques for testing the nucleic acid, including determining expression from a human gene and measuring the amount of RNA expressed from the gene using reverse transcriptase polymerase chain reaction (RT-PCR).
Additionally, the patent includes methods for testing the nucleic acid for the presence of human DNA with epigenetic modifications, such as aberrant methylation. Specific genes and promoter regions that can be tested for epigenetic modifications are listed in the patent.
Finally, the patent describes a method for testing the second portion of the fecal sample for the concentration of hemoglobin, which indicates the presence of blood in the sample. Immunochemical detection of hemoglobin is used for this testing, and different concentration thresholds are provided to determine a positive result for the presence of blood.
Overall, this patent presents a method for processing freshly-collected fecal samples without freezing, allowing for the testing of nucleic acid and blood proteins in the sample. The method has potential applications in medical diagnostics and research.