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Commerciële DNA-testen – Reactie 23andMe

Commerciële DNA-testen – Reactie 23andMe

Ook 23andMe heeft (in het Engels) gereageerd op de uitzending van de online te verkrijgen DNA-testen voor consumenten. We legden de testaanbieder de kritische stellingen van de experts over de kwaliteit van de testen voor. Hierna komt eerst telkens de stelling, gevolgd door de reactie van 23andMe hierop.

The test only focuses on a very limited number of DNA locations, therefore there's a chance it misses a lot of potential outcomes

23andMe is a broad screen to identify genetic health risks you may be unaware of, especially for people who may not qualify for clinical testing. Our genotyping array tests for more than 650,000 genetic variants of known significance for health and ancestry.

We don't market ourselves as a diagnostic test, or a test for people who have a family history of disease or other factors that should instead lead to clinical testing.

Underscoring the need for broader screening like 23andMe, a study published in the Journal of American Medical Association on population screening for BRCA1 and BRCA2 risk variants states: 'Notably, 50 procent of families found to harbor BRCA1 or BRCA2 mutations had no history of breast or ovarian cancer that would have triggered clinical attention.'

We have many documented cases of customers who have identified an unexpected health risk through 23andMe, had clinical confirmatory testing and subsequent interventions prescribed by healthcare providers.

These people would not have otherwise known of their risk but for the 23andMe test. However, it's also important to note that we recommend anyone who receives a positive result, or has questions about their results, visit a healthcare provider for further consultation and confirmatory testing.
 
On accuracy, our standards are incredibly high, as our reports are an FDA-regulated medical device. As part of the FDA review process, we showed our test to be over 99.5 procent analytically accurate for the health reports we provide.
 
The results are not clear for consumers, i.e. the importance between relative and absolute risk are not clearly explained, also 'slightly increased' is not clear what this means.

As part of the FDA review process, we proved that consumers could accurately understand our health reports. A demographically diverse population study demonstrated a 90 procent or greater user comprehension of the concepts conveyed in our Genetic Health Risk tests, including what a '0 variant' result means.

Our tests look for genetic variants associated with certain health conditions, such as Alzheimer's and Celiac disease, and identify whether a customer has one of these variants, and therefore may have an increased risk of developing it.

The reports state quite clearly what the testing result is and what it means for health risk.
 
It is important to note that 23andMe is by no means diagnostic and while having a particular variant can be linked to a higher risk for a condition, it does not necessarily mean you will develop the condition.

We also make it clear in our reports, however, that is not only your genetics that can impact this, lifestyle and environment factors also contribute.

The test explains about Alzheimer, this is something you cannot get properly tested in this type of commercial DNA test, it requires more specific expertise. 

Late-onset Alzheimer's disease is influenced by genetics. The ε4 variant in the APOE gene is the most common genetic variant associated with the disease.

This means that people with at least one copy of the ε4 variant have an increased risk of developing late-onset Alzheimer's disease.

Each genetic health risk report describes if a person has variants associated with a higher genetic risk of developing a disease but does not describe a person's overall risk of developing it.

Again, please note the test is not diagnostic or intended to tell customers anything about their current state of health, and should not be used to make medical decisions. It's always worth being aware of other lifestyle and environmental factors that could contribute to certain conditions.
 
About Alzheimer: it is also morally questionable if you should tell consumers this without the proper post follow up care in a professional setting.

We would always encourage individuals to fully read about our product offering before going ahead with their own test.

At 23andMe, we value trust and transparency and our customers do have to make several informed decisions before ever seeing a risk result like late-onset Alzheimer's, discovering new DNA relatives or having their own data visible to other customers.

For the health reports customers must 'opt in' to see their genetic risk reports, and the same goes when using the ancestry kits – customers can choose whether or not they want to see their DNA relatives.

We are also very transparent with the information presented to customers when they are making these choices. Customers must undergo a second opt-in for sensitive reports, like our Late-onset Alzheimer's report.

They will also need to complete an education module for those reports, which clearly outlines the information they may learn. For the Late-onset Alzheimer's report specifically, there is a video explainer from Dr. Richard Isaacson, a neurologist specializing in Alzheimer's disease treatment and prevention.

For anyone who does go through the opt-in process and would like further information, we would always recommend getting in touch with our customer care team.

We also have a customer care section on our website, readily available to both customers and non-customers, which does share more information about understanding reports and what to do if they are concerned about a particular result.

Overall the test is not very reliable and potentially misleading for consumers.
 
23andMe's 100+ personalized reports on health, wellness, traits and ancestry are highly accurate and are backed by science. Our health-related reports for genetic health risks and carrier status meet the criteria for being scientifically and clinically valid.

We proved through the FDA review process our ability to accurately call, or find, these variants with 99.5 procent accuracy in concordance to Sanger sequencing, the gold standard for accuracy.

We use a method called genotyping, a well-established and reliable way to analyse DNA – and our team of scientists and medical experts use robust processes to develop reports and ensure validity.

Further to this, for our health tests we were required to conduct user comprehension testing, and are held to a standard of greater than 90 percent consumer comprehension of the genetic concepts in the reports we are providing.

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