Basic Information
- Primary DI
- 08437023437025
- Basic UDI-DI Code
- B-08437023437025
- Reference
- CRC-01-2250-01
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- GOODGUT, SLU
Additional Description
The device is derived directly from GoodGut's know-how, as well as from the patents generated from it (EP1482074, PCT/EP2015/054451 and PCT/EP2020/056575), in which an improved method for the screening, diagnosis and/or monitoring of colorectal neoplasia is described. Whereas the use of a part of the markers is justified by the aforementioned patents, the use of the other markers that are included in the RAID-CRC test is justified by the state-of-art knowledge about the relationship between the gut microbiota and different intestinal disorders. Besides, subsequent performance studies both analytical and clinical derived from the most recent scientific literature support the use of the selected markers. Asymptomatic individuals aged equal to or more than 50 years. This population is the target population of organized colorectal cancer screening programs worldwide. is used in symptomatic individuals as a screening step to discard colorectal cancer. RAID-CRC Symptomatic is based on the patented technology that detects a combination of 4 bacterial markers analysed in faecal samples: Bacteroides fragilis, Bacteroides thetaiotaomicron, Peptostreptococcus stomatis, and Eubacteria. Although the results obtained from the qPCR are quantitative the diagnostic is qualitative: Positive, Microbiota compatible with advanced colorectal neoplasia; or Negative, Microbiota non-compatible with advanced colorectal neoplasia.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060399 | FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER |
Available In Countries
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