ColoSense makes a step forward in Colorectal Cancer screening with FDA approval of Updated Stool Collection Method
Geneoscopy is a relatively new company in the area of Cancer Screening Diagnosis, providing an RNA-sequencing-based method to detect the presence of cancer and precancerous advanced adenomas that has similarities to Exact Science’s Cologuard in terms of being a Stool Collection assay.
A while ago, Exact Sciences sued Geneoscopy for infringing on their US Patent No. 11,634,781, which is the basis of their sample collection and processing used in Cologuard. Earlier this month, the Appeal Board of the USPTO invalidated such patent, which gives Geneoscopy freedom to operate in their stool collection method.
On Thursday, Geneoscopy announced that they had received US FDA approval for a streamlined stool collection kit for their assay. This new kit no longer requires patients to separate their sample into multiple containers, a messy business that detracted many potential patients from performing the stool-based at-home screening for colorectal cancer.
Geneoscopy aims at achieving 80 percent compliance for colorectal cancer screening with their updated method. In similar ways that Cologuard’s “poo in a bucket” assay has been attempting to increase screening compliance for people who otherwise would only have a colonoscopy as an option, ColoSense is now entering this area with an easier collection method that threatens to carve market share out of Cologuard’s customer base.