The inherent and often variable nature of gastrointestinal diseases can make the diagnosis, prognosis and prediction of therapeutic response fundamentally complex, and challenging. The current standard may require routine medical visits, frequent endoscopic procedures, and must be timed with symptomatic presentation by the patient. Fortunately, evaluating biomarkers from stool samples presents the possibility for a patient-friendly and effective means of assessing GI health.
Geneoscopy’s sample procurement method uses an at-home, non-invasive collection system that can be integrated into any clinical trial.
Geneoscopy’s RNA extraction platform enables access to a variety of clinically relevant biomarkers, including: GI enterocytes, lymphocytes, and host-microbiome interaction. This allows for opportunities as standalone tests, companion diagnostics, and/or clinical trials tools.
RNA extracted via our proprietary technology provides platform-agnostic RNA quantification, which can be evaluated using next-generation sequencing, ddPCR, qPCR, molecular barcoding, or microarray technologies.
Geneoscopy has developed a novel method to reliably extract eukaryotic RNA in stool samples. Our platform can evaluate gastrointestinal enterocytes, lymphocytes, as well as the host-microbiome interaction.
Geneoscopy’s product development process has been validated through its existing RNA-FIT assay for the detection of both colorectal cancer and advanced adenomas 1, 2. This RNA-FIT assay has received FDA breakthrough device designation and is undergoing analytical verification and clinical validation through a 10,000-patient prospective clinical trial to support an FDA premarket approval application. Geneoscopy is deploying the methods used for the development of the RNA-FIT assay for colorectal cancer screening to develop novel tests for additional gastrointestinal indications to address significant unmet needs for patients, clinicians, and payors.
Geneoscopy has evaluated stool samples and developed a stool biobank that is composed of a variety of samples with different disease indications. This includes samples with both malignant and benign neoplastic lesions, samples with inflammatory conditions (e.g., inflammatory bowel disease), and samples with infectious disease. Geneoscopy has also developed a comprehensive signature for healthy individuals with no disease findings. This extensive understanding of the stool-derived transcriptome provides insight into how these biomarkers can be used to provide information about a variety of different disease indications and applications.
Geneoscopy can work with you to determine diagnostic, prognostic and predictive information for patients being treated for a variety of gastrointestinal diseases. Geneoscopy’s platform can be leveraged across a variety of biomarker types, including RNA Expression, Expressed RNA Variants, and Protein Concentrations. Geneoscopy has developed efficacious machine learning pipelines for evaluating RNA biomarkers to correlate transcriptome signatures with clinical endpoints. The resultant data may provide critical information associated with therapeutic response/resistance as well as ascertain important aspects of patient health.
For more information you can contact us at partnering@geneoscopy.com
REFERENCES
1. Barnell, E. K., et al. (2019) Noninvasive Detection of High-Risk Adenomas Using Stool-Derived Eukaryotic RNA Sequences as Biomarkers, Gastroenterology. doi: 10.1053/j.gastro.2019.05.058
2. Barnell, E. K., et al. (2021) Multitarget Stool RNA Test for Noninvasive Detection of Colorectal Neoplasias in a Multicenter, Prospective, and Retrospective Cohort. Clinical and Translational Gastroenterology. doi: 10.14309/ctg.0000000000000360
