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FDA approves consumer genetic test for colorectal cancer risk

28 January 2019
Appeared in BioNews 984

The US Food and Drug Administration (FDA) has approved a direct-to-consumer genetic test for a hereditary form of colorectal cancer by 23andMe. 

The test is the second consumer genetic test for cancer risk, with the first being a test for mutations in the BRCA1 and BRCA2 genes, also developed by 23andMe. The test will identify mutations linked to MUTYH-associated polyposis (MAP), a hereditary condition that leads to a heightened risk of colorectal cancer. 

'We are committed to giving people affordable and direct access to important health information that can impact their lives,' said Anne Wojcicki, 23andMe chief executive.

As with 23andMe's first cancer risk test, concerns have been raised about whether customers will have access to adequate information to interpret their results. 23andMe noted that a negative test for MAP-linked gene variants doesn't mean that they are not at risk of hereditary forms of colorectal cancer, as MAP makes up only 5 percent of colorectal cancer cases. The test will also only detect two variants linked to MAP, out of more than 100 variants known to be implicated. 

'We don't have as much data on what it means to have one mutation,' Rachelle Chambers, manager for genetic counselling at the High-Risk Cancer Genetics Programme at the NYU Langone Perlmutter Cancer Centre, told Futurism. 'The risks associated with one mutation are not as clear.'

23andMe stated that its customers will be given an online 'educational module' on how to interpret the information in their report to address these problems. The firm tested the information it provided on a group of people from diverse backgrounds, achieving 90 percent comprehension, according to 23andMe. However, the firm did not clarify if this meant that 10 percent of people did not understand the information, or that on average people understood only 90 percent of what was being said. 

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