PET PET
  • My Account
  • Subscribe
Become a Friend Donate
  • About Us
    • People
    • Press Office
    • Our History
  • Get Involved
    • Become a Friend of PET
    • Volunteer
    • Campaigns
    • Writing Scheme
    • Partnership and Sponsorship
    • Advertise with Us
  • Donate
    • Become a Friend of PET
  • BioNews
    • News
    • Comment
    • Reviews
    • Elsewhere
    • Topics
    • Glossary
    • Newsletters
  • Events
    • Upcoming Events
    • Previous Events
  • Engagement
    • Policy and Projects
      • Resources
    • Education
  • Jobs & Opportunities
  • Contact Us
  • About Us
    • People
    • Press Office
    • Our History
  • Get Involved
    • Become a Friend of PET
    • Volunteer
    • Campaigns
    • Writing Scheme
    • Partnership and Sponsorship
    • Advertise with Us
  • Donate
    • Become a Friend of PET
  • BioNews
    • News
    • Comment
    • Reviews
    • Elsewhere
    • Topics
    • Glossary
    • Newsletters
  • Events
    • Upcoming Events
    • Previous Events
  • Engagement
    • Policy and Projects
      • Resources
    • Education
  • Jobs & Opportunities
  • Contact Us
  • My Account
  • Subscribe
  • Privacy Statement
  • Advertising Policy
  • Thanks and Acknowledgements
PETBioNewsNews23andMe test for cancer risk gains FDA approval

BioNews

23andMe test for cancer risk gains FDA approval

Published 9 March 2018 posted in News and appears in BioNews 941

Author

Anna Mallach

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.

The first direct-to-consumer test for cancer risk genes has been approved by the US's Food and Drug Administration...

The first direct-to-consumer test for cancer risk genes has been approved by the US Food and Drug Administration (FDA).

Personal genetics company 23andMe received approval for a genetic test for three of the roughly 1000 mutations in the BRCA1 and BRCA2 genes that are associated with an increased risk of developing breast, ovarian and prostate cancer. While these mutations are common in people of Ashkenazi Jewish descent, with one in 40 individuals carrying them, they are rare in the wider population.

The new test 'has a lot of caveats', said Donald St. Pierre, at the FDA's Centre for Devices and Radiological Health. 'While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual's risk are not detected by this test.'

Women with the genetic variants assessed by 23andMe's test have a 45-85 percent higher chance of developing breast cancer by the age of 70. 'This authorisation is incredibly valuable for those who might not be aware of their Ashkenazi Jewish descent or aren't familiar with their family history of cancer,' said Anne Wojcicki, CEO and co-founder of 23andMe.

But Wojcicki, along with the FDA and other experts cautioned that a negative report from 23andMe on these three BRCA mutations does not exclude the possibility of a person carrying another BRCA mutation associated with an increased risk of developing cancer. 'For other groups with different […] mutations, and there are many, it won't help much. There's a big need for users to understand that nuance, which is not widely understood,' Dr Robert Cook-Deegan at Arizona State University, told STAT.

23andMe's test relies on a saliva sample to test for the BRCA mutations. Normally, only women with a family history of breast cancer get referred for genetic testing to investigate their BRCA status. If mutations which increase the risk of developing cancer are found, preventive measures include regular check-ups, potential lifestyle changes and possibly preventive surgery.

Related Articles

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
Reviews
1 August 2019 • 3 minutes read

Podcast Review: 23andMe (and You, and Everyone Else) — Freakonomics

by Francesca Sowerbutts

23andMe advertises itself on its website as a way to 'meet your genes'. You can send off a spit sample, and for $99-$199, a report based on your genetics will be emailed to you a few weeks later...

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
News
22 July 2019 • 3 minutes read

Experts speak out on direct-to-consumer genetic testing

by Shaoni Bhattacharya

Geneticists in the UK have been speaking out against direct-to-consumer DNA testing after concerns over false positive results...

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
News
25 January 2019 • 1 minute read

FDA approves consumer genetic test for colorectal cancer risk

by Martha Henriques

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

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
News
2 November 2018 • 2 minutes read

FDA approves DNA test for predicting drug effectiveness — if it carries warnings

by Kulraj Singh Bhangra

The US Food and Drug Administration has approved the first consumer pharmacogenetic test, but not without crucial caveats...

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
News
27 July 2018 • 2 minutes read

Glaxo invests $300m in 23andMe to use its genomic data for research

by Dr Alexander Ware

The pharmaceutical firm GlaxoSmithKline is investing US$300 million in 23andMe as part of a four-year collaboration that will give it access to the DNA testing firm's genetic data resources...

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
Comment
27 February 2018 • 4 minutes read

Personal genetic testing and the implications for the donor conception community

by Debbie Kennett

2017 was the year that personal genetic testing took off in a big way...

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
News
13 February 2018 • 2 minutes read

Sequencing company proposes trading genetic information for cryptocurrency

by Ruth Retassie

Nebula Genomics, a new firm founded by geneticists, has announced its plan to sequence customers’ genomes cheaply and allow them to sell their own genomic information for digital money...

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
News
6 February 2018 • 1 minute read

Record-breaking study links over 950 genes to insomnia

by Shaoni Bhattacharya

A large study of the genomes of over 1.3 million people has found 956 genes implicated in insomnia...

Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the output from a DNA sequencing machine.
CC BY 4.0
Image by Peter Artymiuk via the Wellcome Collection. Depicts the shadow of a DNA double helix, on a background that shows the fluorescent banding of the sequencing output from an automated DNA sequencing machine.
News
3 November 2016 • 2 minutes read

23andMe halts development of next-generation gene sequencing

by Kulraj Singh Bhangra

Personal genomics company 23andMe has halted plans to develop next-generation sequencing technology, it has revealed ...

Leave a Reply Cancel reply

You must be logged in to post a comment.

« Malfunction at clinic may compromise frozen eggs and embryos

Data-Label The UK's Leading Supplier Of Medical Labels & Asset Labels

RetiringDentist.co.uk The UK's Leading M&A Company.

Find out how you can advertise here
easyfundraising
amazon

This month in BioNews

  • Popular
  • Recent
13 June 2022 • 2 minutes read

Drop in diversity of blood stem cells leads to old-age health issues

8 August 2022 • 2 minutes read

Placenta and organ formation observed in mouse embryo models

8 August 2022 • 2 minutes read

Complex structures of the human heart bioengineered

8 August 2022 • 1 minute read

Brain tumour gene also linked to childhood cancers

8 August 2022 • 2 minutes read

Lower hormone doses may improve IVF egg quality

8 August 2022 • 2 minutes read

Boosting muscle cell production of gene therapy proteins

Subscribe to BioNews and other PET updates for free.

Subscribe
  • Twitter
  • Facebook
  • Instagram
  • LinkedIn
  • YouTube
  • RSS
Wellcome
Website redevelopment supported by Wellcome.

Website by Impact Media Impact Media

  • Privacy Statement
  • Advertising Policy
  • Thanks and Acknowledgements

© 1992 - 2022 Progress Educational Trust. All rights reserved.

Limited company registered in England and Wales no 07405980 • Registered charity no 1139856

Subscribe to BioNews and other PET updates for free.

Subscribe
PET PET

PET is an independent charity that improves choices for people affected by infertility and genetic conditions.

  • Twitter
  • Facebook
  • Instagram
  • LinkedIn
  • YouTube
  • RSS
Wellcome
Website redevelopment supported by Wellcome.

Navigation

  • About Us
  • Get Involved
  • Donate
  • BioNews
  • Events
  • Engagement
  • Jobs & Opportunities
  • Contact Us

BioNews

  • News
  • Comment
  • Reviews
  • Elsewhere
  • Topics
  • Glossary
  • Newsletters

Other

  • My Account
  • Subscribe

Website by Impact Media Impact Media

  • Privacy Statement
  • Advertising Policy
  • Thanks and Acknowledgements

© 1992 - 2022 Progress Educational Trust. All rights reserved.

Limited company registered in England and Wales no 07405980 • Registered charity no 1139856