OncoFirm-CEA
OncoFirm-CEA
Rapid Test for Carcinoembryonic Antigen (CEA) – Colorectal, Breast, Lung, and Pancreatic Cancer Screening
Overview:
OncoFirm-CEA is a rapid diagnostic test developed by OncoFirm Diagnostics for the detection and monitoring of Carcinoembryonic Antigen (CEA), a well-established biomarker associated with colorectal cancer and other solid tumors, including breast, lung, and pancreatic cancers. Built on our advanced lateral flow assay (LFA) platform, OncoScreen-CEA delivers accurate, lab-quality results in under 15 minutes, enabling timely and accessible cancer screening at the point of care.
Key Features:
- CEA Biomarker Detection: Detects elevated CEA levels in serum, plasma, or whole blood.
- Multi-Cancer Utility: Supports detection and monitoring of colorectal, breast, lung, and pancreatic cancers.
- Rapid Results: Delivers easy-to-read results within 15 minutes, with no lab equipment required.
- Clinically Meaningful Thresholds: Designed to identify CEA concentrations above commonly used diagnostic cutoffs.
- Point-of-Care Ready: Ideal for use in oncology clinics, general practice, and community-based cancer screening programs.
Clinical Applications:
- Early detection and monitoring of colorectal and other CEA-producing cancers
- Post-treatment surveillance and recurrence monitoring
- Risk stratification for patients with cancer symptoms or family history
- Supplemental diagnostic tool in conjunction with imaging and biopsy
Benefits for Healthcare Providers:
- Enhances diagnostic confidence with quantitative, biomarker-based results
- Facilitates early intervention and personalized treatment planning
- Enables quick triage decisions in outpatient or low-resource settings
- Improves access to screening in underserved or rural communities
Regulatory Status:
OncoFirm-CEA is CE-marked for use in international markets. Regulatory pathways for FDA approval and global distribution are in progress.**
