OncoFirm™ / Pipeline / OncoFirm™-R
Pipeline concept · Investigational
OncoFirm™-R: Investigational TF / Gal-GalNAc Assay for Colorectal and Pancreatic Cancer Research
Investigational device. OncoFirm™-R is a concept-stage product in development. It has not been cleared or approved by the U.S. Food and Drug Administration or any other regulatory authority, is not CE marked and is not available for sale. For research and investigational use only. Performance characteristics have not been established and no clinical claims are made.
OncoFirm™-R is a single-use lateral flow assay concept under development by OncoFirm™ Diagnostics to measure the Thomsen–Friedenreich (TF) glycoantigen, also called Gal-GalNAc, in blood. OncoFirm™ is investigating whether a rapid, low-cost test for circulating TF antigen could one day contribute to the evaluation of people at elevated risk of colorectal and pancreatic cancer. That question is unanswered, and nothing on this page should be read as a claim that the assay detects cancer.
At a glance
Analyte
Thomsen–Friedenreich (TF) glycoantigen, Galβ1-3GalNAc (CD176), also called Gal-GalNAc
Research focus
Colorectal and pancreatic cancer
Stage
Concept stage; no performance data published
Format
Single-use fluorescent lateral flow cassette with the OncoFirm™ reader (in development)
Status
Not FDA cleared or approved; not CE marked; not for sale
Development stage
Research objective
This section takes the place of an intended-use statement. An intended use will be proposed only when validation data support one.
- Analytical objective: to establish whether OncoFirm™-R detects TF glycoantigen in blood specimens with acceptable sensitivity, specificity, precision and freedom from interference at a defined cutoff.
- Clinical research question: to evaluate whether circulating TF antigen, as measured by this assay, is associated with colorectal and pancreatic cancer in a defined study population, and whether any association is strong and specific enough to be useful alongside existing methods of evaluation.
- Scope: OncoFirm™-R is not being developed as a substitute for colorectal cancer screening with colonoscopy or stool-based tests, which the USPSTF recommends for adults aged 45 to 75.
- Scope: It is not intended for pancreatic cancer screening. The USPSTF recommends against screening for pancreatic cancer in asymptomatic adults.
Product design
Design specifications
These are design targets. Performance has not been established.
| Specification | Design status |
|---|---|
| Analyte | TF glycoantigen (Galβ1-3GalNAc). The form measured, and the capture and detection reagents, will be defined during development. |
| Specimen types | Serum, plasma or whole blood, each to be confirmed in analytical validation |
| Format | Single-use lateral flow cassette |
| Readout | Fluorescent signal read with the OncoFirm™ handheld reader (in development) |
| Time to result | About 15–20 minutes (design target) |
| Cutoff | Under evaluation |
| Software | Reader and companion software in development; to be evaluated as part of the regulated test system |
| Storage and shelf life | To be established in stability studies |
Learn how the platform works in the fluorescent lateral flow platform and digital diagnostic readers.
Science
About the TF glycoantigen
- The TF antigen (Galβ1-3GalNAcα-O-Ser/Thr, also called CD176 or the T antigen) is a two-sugar structure on cell-surface glycoproteins. On healthy cells it is usually hidden by sialic acid; on many carcinomas it is exposed.
- Because it is expressed across many carcinoma types, TF antigen is not specific to any one cancer. A TF result cannot by itself indicate the organ of origin.
- Gal-GalNAc in colonic mucus has been studied for decades as a marker of colorectal neoplasia, including with the galactose oxidase–Schiff reaction. Blood measurement is a separate and much earlier question.
- Most published work uses tumor tissue. Measuring TF antigen in blood is at an early research stage, and the effects of smoking, inflammation, infection and benign disease on circulating TF have not been characterized.
- No TF-antigen-based blood test is currently cleared or approved by the U.S. FDA for any cancer detection purpose.
Background: Thomsen–Friedenreich antigen, peanut agglutinin and TF detection and MUC1.
Limitations
What this assay is not
- Performance characteristics of OncoFirm™-R, including sensitivity, specificity, precision and interference, have not been established. No clinical performance claims are made.
- Established colorectal cancer screening uses colonoscopy, stool-based tests or other USPSTF-recommended methods. There is no recommended blood-biomarker screening test for pancreatic cancer in average-risk adults.
- A result could not localize a cancer to a specific organ; TF antigen is expressed by many carcinoma types and may be present in some non-malignant conditions.
- A result below a cutoff would not exclude cancer, and a result above it would not establish cancer.
- Not for self-testing or home use.
Development and regulatory status
Where the program stands
- Development: OncoFirm™-R is at concept stage and no performance data have been published. Any analytical or clinical studies will be registered where required, and findings will be published or submitted to regulators as they become available.
- United States: OncoFirm™-R has not been cleared or approved by the FDA and is not available for sale. Any U.S. use is limited to investigational use. The timing and outcome of any regulatory review cannot be assured.
- European Union and other markets: OncoFirm™-R is a product in development and has not been CE marked or authorized for sale in any market.
- Images: product images are concept renderings that illustrate intended functionality.
See all programs in one reader, one strip design, the multiplex concept OncoFirm™ MultiDx and the media kit.
Related
Related programs and guides
Research and investigational inquiries
Research institutions, laboratories and potential clinical collaborators can contact OncoFirm™ about OncoFirm™-R. Inquiries are limited to research and investigational use. Collaboration inquiry