New Colorectal Cancer Screening Tests

There are several new types of colorectal cancer screening tests currently being evaluated. One of these, the Epi proColon (Epigenomics AG), has recently been approved by the US Food and Drug Administration (FDA). 

It is already available in Europe and some other countries. This test uses a blood sample rather than a stool sample like the faecal occult blood screening tests currently in use.

The Epi proColon test detects methylated DNA from the Septin9 gene, in plasma obtained from whole-blood specimens. In the US the FDA have approved the test for use in average-risk patients who have chosen not to undergo other screening methods, such as colonoscopy or stool-based tests. The reason that the test approval is restricted is because evaluations so far have shown the test to be no more effective than current faecal occult blood tests but considerably more expensive.

In Australia another blood-based test that detects methylated DNA has also been developed. This is the ColoVantage Plasma test, a blood test developed in partnership by Clinical Genomics and the CSIRO. This test is still being evaluated in clinical trials.

Another DNA-based test for screening for colorectal cancer is the ColoGuard test which measures both haemoglobin (like the faecal occults blood tests) and also cancer-associated DNA in a stool sample. This test is also approved for use in the US. A recent evaluation by Australian experts however found that while this test does detect more cancers it also has a higher false-positive result rate which means that many people would have to undergo an unnecessary invasive colonoscopy test. This combined with the high cost of the test resulted in the expert group finding that it was unsuitable for population screening in Australia.

Further Reading

HEALTHPACT Review (pdf)
Bowel Cancer Australia
Epi proColon website
Cologuard website
Colovantage website

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