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Startup launches budget BRCA test

27 April 2015
Appeared in BioNews 799

A US company has announced a low-cost genetic test for breast cancer.

Color Genomics, based in Silicon Valley in California, USA, says the kit tests for 19 genetic markers that indicate increased risk of hereditary breast or ovarian cancer, including BRCA1 and BRCA2.

The company wants 'every woman' to have access to genetic screening for breast and ovarian cancer. It also says that women will have the option to donate money when they purchase the test to support those who cannot afford it.

Co-founder Elad Gil said, 'Color's goal is to democratise access to genetic testing.'

At $249, the service offered by Color is considerably cheaper than other tests for BRCA1 and BRCA2 in the USA, which can cost between $400 and $4,000. Genetic counselling is included as part of the service offered by Color.

The tests can be ordered by customers' own doctors or doctors appointed by the company, who will review a woman's information. The doctors will also receive the results. The New York Times reports that the US Food and Drug Administration has said companies who operate their own laboratories do not require its approval if doctors order the tests.

Some commentators have cautioned that an expansion of genetic testing could lead to more people finding out they have mutations that cannot be assessed as dangerous or benign. In The New York Times, Dr Kenneth Offit, of Memorial Sloan Kettering Cancer Center in New York, said: 'We have to be careful that we are not just increasing this group of worried-­well who have incomplete information.'

The US National Cancer Institute states that around 10 percent of women undergoing BRCA1 and BRCA2 testing receive an 'uncertain result', where the mutation identified is not known to affect a person's risk of cancer.

The concern is that women whose results are ambiguous may elect risky and invasive procedures that may not be necessary. News of actress Angelina Jolie's risk-reducing double mastectomy led to a greater number of women seeking genetic testing, leading to experts sending out a message that preventative surgery is not for everyone (see BioNews 772).

Others have questioned why the company is advocating that 'every woman' should have the choice of genetic testing. In the UK, NICE only recommends genetic testing for those consider at risk.

Dr James Flanagan, of Imperial College London's department of surgery and cancer, told Wired, 'It is great that they can offer it at such small cost.' However, he suggests a better system would be to offer all women the opportunity to find out their level of risk, and offer the test only to those who are at high risk.

'I think it would be great to offer all women the opportunity to use the computational model to assess their chances of having a mutation. That can happen for free. Then those that have a high chance can have the test,' he said.

Around 5 to 10 percent of breast cancers are attributed to hereditary causes, whereas 27 percent are attributed to lifestyle, including obesity, smoking and high alcohol intake.

Professor Mary-Claire King of the University of Washington, who identified the BRCA1 gene and is an unpaid advisor to Color Genomics, told NPR: 'We need to be able to offer all women the opportunity to be sequenced for BRCA1 and BRCA2 - and, indeed, their sister genes - when a woman is young enough to make a plan if [it turns out] she does have the misfortune of having a mutation.' (See also BioNews 771.)

SOURCES & REFERENCES
Breast cancer gene testing set to become cheaper and easier
The Guardian |  21 April 2015
Cancer Touches Everyone
Color Genomics |  20 April 2015
Color Genomics launches $249 breast cancer risk test
Wired |  22 April 2015
New Genetic Tests for Breast Cancer Hold Promise
New York Times |  21 April 2015
Screening Tests For Breast Cancer Genes Just Got Cheaper
NPR |  21 April 2015
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