FDA 23andMe

FDA Greenlights 23andme GHR Test: Genetic Testing Now Available To The Public

Today, the U.S. Food and Drug Agency announced the approval of direct-to-consumer marketing for the Personal Genome Service Genetic Health Risk (GHR) tests by the 23andMe company. According to the agency, the GHR will provide you with information on ten serious disorders you may or may not be predisposed to.

Consumers can order their personal home-based saliva collection kits for $199 and follow what the 23andMe indicates are easy instructions to collect your spittle. The results are then sent to 23andMe for testing.

How the 23andMe GHR Test Works

FDA 23andMe
[Image by Ulrich Baumgarten/Getty Images]

The 23andMe GHR tests work by isolating the DNA from your saliva. From there, the DNA is tested for over 500,000 genetic variants. The absence or presence of these variants can indicate a higher risk that you will develop any of the following conditions:

  • Late-onset Alzheimer’s;
  • Celiac Disease;
  • Alpha-1 antitrypsin deficiency;
  • Early-onset primary dystonia;
  • Parkinson’s disease;
  • Factor XI deficiency;
  • Gaucher disease type 1;
  • Glucose-6-Phosphate Dehydrogenase deficiency (G6PD);
  • Hereditary hemochromatosis;
  • and Hereditary thrombophilia.

Should People Prioritize Getting the GHR Test?

Jeffrey Shuren, M.D., who is the director of the FDA’s Center for Devices and Radiological Health, had the following to say about the new 23andMe GHR Test.

“Consumers can now have direct access to certain genetic risk information,” said “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”

In other words, the results of the test can help you and your doctor make an informed decision about how to mitigate any potential health risks. You’ll also be able to make any necessary lifestyle adjustments to decrease your risk of developing a serious illness.

‘Angelina Jolie’ Genetic Test Not an Option

FDA 23andMe
[Image by Richard Shotwell/AP Images]

One of the most famous examples of using genetic testing to determine whether or not there is a predisposition to a disease involves Academy Award winner Angelina Jolie. Jolie found out through genetic testing that she carries the hereditary BRCA1 gene mutation, which increased her risk of ovarian and breast cancer. The actress and humanitarian later elected to use preventive surgery to ward off those particular types of cancer. In the end, Jolie had a double mastectomy and surgery to remove her ovaries and fallopian tubes.

The genetic tests for BRCA were excluded from today’s 23andMe company’s marketing authorization, along with any future GHR tests that perform the role of medical diagnostic testing. The FDA stressed that the 23andMe GHR test is only intended to provide your genetic risk, not to determine your overall risk of developing a disease or condition. The agency also indicated that many factors play a role in the risk of developing a health condition. Therefore, genetic tests such as the BRCA that can yield a positive for cancer should be part of diagnostic testing conducted by a healthcare professional.

Safety Concerns for GHR Testing

The 23andMe GHR test isn’t without risks. According to the FDA, some of the risks associated with its usage include “false positive findings, which can occur when a person receives a result indicating incorrectly that he or she has a certain genetic variant, and false negative findings that can occur when a user receives a result indicating incorrectly that he or she does not have a certain genetic variant.”

Additionally, there is a concern about privacy. Scientific American reported that 23andMe stated they reserve the right to use personal information, including your genome. The company indicated they will use this information to sell consumers merchandise and selected services. There is also a concern with how your personal information may be used by Big Pharma and insurance companies. For example, your personal information could potentially be tailored to sell you (or deny you) certain merchandise and services. Therefore, it’s vital to be aware that 23andMe reserves the right to use your personal information—including your genome—to inform you about events and to try to sell you products and services.

23andMe insists that that is not an acceptable use of their database, but on the other hand, they say they will share aggregate information about consumer’s genomes to third parties. Company representatives went on record to say they won’t provide your genetic information without your consent. Hopefully, this is accurate, but privacy concerns are natural when so many personal details are required by any business that expressly states they reserve the right to share the personal information they collect.

What’s Next for GHR Testing?

In the near future, developers of other GHRs may be entering the market, as well. Director Shurer stated that the FDA will most likely exempt additional GHR tests that 23andMe conducts from their premarket review. Additionally GHR tests from other companies will get the same courtesy after submitting their first premarket notification to the FDA. The exemption would let similar tests enter the market after the agency conducts a one-time review “in the least burdensome way.”

[Featured Image by Phil Carrick, Fairfax Media Contributor/Getty Images]

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