Abstract
Aim: To identify new and emerging screening tests for colorectal cancer
(CRC) that involves detection of various biomarkers like blood, DNA and
RNA in samples of faeces, tissue or blood.
Current practice: Screening for CRC can be done by bowel visualisation
techniques and tests that measure biomarkers. The Bowel Cancer Screening Programme (BCSP) in England uses a guaiac faecal occult blood test.
Methods: The strategy was to search available literature, identify developers
and contact them for relevant information. Advice from experts was sought on potential utility and likely impact of identified technologies on the BCSP.
Results: Ninety-three companies and five research groups were contacted. Sixty-nine relevant tests were identified. Detailed information was available for 48 tests, of these 73% were CE marked and the remainder were considered as emerging. Forty-nine tests use immunochemical methods to detect occult blood in faeces. Eight, four and two tests detect biomarkers in a sample of blood, or exfoliated cells either shed in faeces or collected from rectal mucosa respectively. Six tests were grouped as ‘other tests’. Most of the identified tests are performed manually and give qualitative detection of biomarkers.
Conclusion: Variation in test performance and characteristics was observed
amongst the 69 identified tests. Automated, quantitative FIT with a variable cut off are the preferred approach in the BSCP. However the units used to report FITs results do not enable comparison across products. Tests detecting biomarkers other than occult blood are more specific to neoplasms but have limited sensitivity due to the heterogeneity of cancer. Research is ongoing to identify an optimal panel of biomarkers, simplifying and automating the test, and reducing the cost.
(CRC) that involves detection of various biomarkers like blood, DNA and
RNA in samples of faeces, tissue or blood.
Current practice: Screening for CRC can be done by bowel visualisation
techniques and tests that measure biomarkers. The Bowel Cancer Screening Programme (BCSP) in England uses a guaiac faecal occult blood test.
Methods: The strategy was to search available literature, identify developers
and contact them for relevant information. Advice from experts was sought on potential utility and likely impact of identified technologies on the BCSP.
Results: Ninety-three companies and five research groups were contacted. Sixty-nine relevant tests were identified. Detailed information was available for 48 tests, of these 73% were CE marked and the remainder were considered as emerging. Forty-nine tests use immunochemical methods to detect occult blood in faeces. Eight, four and two tests detect biomarkers in a sample of blood, or exfoliated cells either shed in faeces or collected from rectal mucosa respectively. Six tests were grouped as ‘other tests’. Most of the identified tests are performed manually and give qualitative detection of biomarkers.
Conclusion: Variation in test performance and characteristics was observed
amongst the 69 identified tests. Automated, quantitative FIT with a variable cut off are the preferred approach in the BSCP. However the units used to report FITs results do not enable comparison across products. Tests detecting biomarkers other than occult blood are more specific to neoplasms but have limited sensitivity due to the heterogeneity of cancer. Research is ongoing to identify an optimal panel of biomarkers, simplifying and automating the test, and reducing the cost.
| Original language | English |
|---|---|
| Number of pages | 14 |
| Journal | GMS Health Technology Assessment |
| Volume | 11 |
| DOIs | |
| Publication status | Published - 10 Jun 2015 |
Keywords
- colorectal cancer
- screening
- Horizon scanning
- biomarkers
Access to Document
- Phalguni_et_al_Tests_detecting_biomarkers_GMS_2015
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/ Checked July 2015