Geneoscopy
Diagnostics company focused on gastrointestinal health that develops stool-derived eukaryotic RNA biomarker assays for noninvasive, at‑home colorectal cancer screening and diagnostics for other GI diseases (including inflammatory bowel disease). Operates a CLIA/CAP‑accredited single‑site clinical laboratory, maintains state laboratory permits, conducts pivotal multicenter clinical trials, pursues regulatory submissions and payer engagement, and forms commercial distribution and research partnerships to expand clinical access.
Industries
Nr. of Employees
medium (51-250)
Geneoscopy
Patents
Products
ColoSense
FDA‑approved, at‑home multi‑target stool RNA screening test for qualitative detection of colorectal neoplasia‑associated RNA markers and occult hemoglobin intended for average‑risk adults aged 45 and older. Per pivotal trial publications, demonstrated high sensitivity for colorectal cancer detection; distributed nationally through laboratory network partnerships and covered under Medicare for eligible beneficiaries.
ColoSense
FDA‑approved, at‑home multi‑target stool RNA screening test for qualitative detection of colorectal neoplasia‑associated RNA markers and occult hemoglobin intended for average‑risk adults aged 45 and older. Per pivotal trial publications, demonstrated high sensitivity for colorectal cancer detection; distributed nationally through laboratory network partnerships and covered under Medicare for eligible beneficiaries.
Services
Consent‑based outreach and live support via text, email, or phone to educate patients about follow‑up colonoscopy, identify practical barriers, and provide non‑directive information about local or in‑network providers and access resources.
On‑site accredited laboratory testing for stool‑based RNA diagnostics delivered from a CLIA/CAP‑accredited single‑site laboratory, available nationwide through laboratory network collaborations.
Collaborative partnerships to provide at‑home sample procurement, stool RNA extraction, biomarker quantification, and analytic support to biopharma and academic research for diagnostic development, companion diagnostics, and clinical trial tools.
Consent‑based outreach and live support via text, email, or phone to educate patients about follow‑up colonoscopy, identify practical barriers, and provide non‑directive information about local or in‑network providers and access resources.
On‑site accredited laboratory testing for stool‑based RNA diagnostics delivered from a CLIA/CAP‑accredited single‑site laboratory, available nationwide through laboratory network collaborations.
Collaborative partnerships to provide at‑home sample procurement, stool RNA extraction, biomarker quantification, and analytic support to biopharma and academic research for diagnostic development, companion diagnostics, and clinical trial tools.
Expertise Areas
- Colorectal cancer screening
- Stool‑derived RNA biomarker discovery and assay development
- Clinical trial design and execution (multicenter)
- Analytical validation and diagnostic performance testing
Key Technologies
- Stool‑derived eukaryotic RNA analysis
- Multi‑target stool RNA panels
- Next‑generation sequencing (NGS)
- Droplet digital PCR (ddPCR)
News & Updates
Launch of a provider‑enabled, opt‑in patient navigation program that provides consented outreach (text, email, phone) and live support to help patients with positive screening results complete follow‑up colonoscopy.
Announcement of nationwide distribution through a commercial collaboration with a national laboratory network enabling broad access to the FDA‑approved stool‑based RNA screening test.
Announcement that Medicare coverage was granted for the FDA‑approved stool RNA colorectal cancer screening test, expanding access for eligible beneficiaries.
Announcement that the American Cancer Society colorectal cancer screening guideline update included the RNA‑based stool screening approach as a preferred option for average‑risk adults aged 45 and older.
Announcement of FDA premarket approval for the multi‑target stool RNA colorectal cancer screening test (PMA), enabling marketing as an FDA‑approved screening option.
Publication of pivotal clinical trial results for the multi‑target stool RNA test in JAMA reporting diagnostic performance data.
Launch of a provider‑enabled, opt‑in patient navigation program that provides consented outreach (text, email, phone) and live support to help patients with positive screening results complete follow‑up colonoscopy.
Announcement of nationwide distribution through a commercial collaboration with a national laboratory network enabling broad access to the FDA‑approved stool‑based RNA screening test.
Announcement that Medicare coverage was granted for the FDA‑approved stool RNA colorectal cancer screening test, expanding access for eligible beneficiaries.
Announcement that the American Cancer Society colorectal cancer screening guideline update included the RNA‑based stool screening approach as a preferred option for average‑risk adults aged 45 and older.
Announcement of FDA premarket approval for the multi‑target stool RNA colorectal cancer screening test (PMA), enabling marketing as an FDA‑approved screening option.
Publication of pivotal clinical trial results for the multi‑target stool RNA test in JAMA reporting diagnostic performance data.