FDA Authorizes Genetic Health Risk Tests by 23andMe

If you have ever wondered if you or your loved ones are at higher risk for diseases such as Late-onset Alzheimer’s disease, read on to learn about big changes that are happeningHealth history is just one of the ways in which genealogy research can benefit your family.

Genetic Health Risk Test
According to a recent FDA press release, “The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional.”

The release goes on to say:

Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “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.”

The GHR tests are intended to provide genetic risk information to consumers, but the tests cannot determine a person’s overall risk of developing a disease or condition. In addition to the presence of certain genetic variants, there are many factors that contribute to the development of a health condition, including environmental and lifestyle factors.

The 23andMe GHR tests work by isolating DNA from a saliva sample, which is then tested for more than 500,000 genetic variants. The presence or absence of some of these variants is associated with an increased risk for developing any one of the following 10 diseases or conditions:

You can read the complete article called FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions here.

Diahan SouthardFDA and 23andMe – Comments from Your DNA Guide

I look to Your DNA Guide, Diahan Southard for all things genetic genealogy, and here’s what she had to say about the recent news:

23andMe is certainly the outlier among our genetic genealogy companies. It is different because its purpose is not necessarily to help you find your ancestors or determine your ethnic composition, though it can do both, but their goal is to empower your personal health.

In November of 2013 the FDA ordered 23andMe to retract all health reporting from their website in order to better regulate the dissemination of health related information to consumers. 23andMe has slowly crawled back toward that same reporting structure, all the while jumping through the compliant hoops that the FDA has set up.

Now this week they have had a major step forward as they have been able to release the risk assessment for 10 major diseases including Parkinson’s and celiac. This is the first such test available direct to consumers, without first going to your doctor.

This is likely the first of many such developments as 23andMe works to make our own health more accessible via our genetics. If you do pursue this kind of evaluation, it is important to keep in mind the words of Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, “…genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”

Learn More About 23andMe

As with all genetic testing, it’s your decision in the end, so be as informed as you can. Diahan’s quick reference guide Understanding 23andMe (a Companion Guide to Autosomal DNA for the Genealogist) will help you tap into the company’s services from a genealogical perspective. Over 1 million people have had their DNA evaluated by 23andMe. This website has powerful family history tools and this guide will answer the most pressing questions like:

  • How can I control how much information is being shared with others?
  • How can I enter my genealogical information?
  • How do I know when I have a good match?
  • Is the YDNA and mtDNA information they give the same as what I see at other places?
  • What is the best way to use the ethnicity results presented?

Census Research Tip: Why Look at the Same Thing Twice

When may it pay off to look at the same records or indexes twice? When you can compare them on different genealogy websites. Here’s an example for this census research tip. census research tip

You’ve probably noticed that some record sets are available online at multiple websites. At each site, the images and indexes you find may be a little different. Online tools for viewing and searching at each site may also be different.

For example, a digitized image may be faded, dark, blurry, blotchy, cut off, or otherwise unreadable on one website but clearer on another site. Here are two images from the first few lines of the 1880 U.S. Federal Census taken in Bay Minette, Baldwin, Alabama. The first image comes from HeritageQuest Online (available at public libraries) and the second is from Ancestry.com. See the difference?

 

 

As you can see, depending on which line you’re reading, one image may be clearer than another.

Here’s another census research tip: The online tools available at each site are different, too. At HeritageQuest Online, you can view the image at original size, 200% or 400%, and you can look at the image as a negative, which sometimes helps faded text stand out a little more. Ancestry.com lets you zoom in and out, magnify specific areas, and rotate the image or view it in mirror form (in case you’re trying to read backward text bleeding through from the other side).

More Gems for Online Genealogy Research

HeritageQuest Online Gets Better with Ancestry’s Support

4 Tips for Getting the Most out of Ancestry.com

Genealogy Gems Premium podcast episode 125: HeritageQuest Online, Ancestry Library edition and other great genealogy resources at the public library (Available only to Genealogy Gems Premium website members)

 

Family History Episode 11 – Census Wrap-Up: Decade-by-Decade to 1790

Listen to the Family History: Genealogy Made Easy podcast by Lisa Louise Cooke. It’s a great series for learning the research ropes and well as refreshing your skills.

Originally published 2009

Republished December 17, 2013

Download the Show Notes for this Episode

Welcome to this step-by-step series for beginning genealogists—and more experienced ones who want to brush up or learn something new. I first ran this series in 2008-09. So many people have asked about it, I’m bringing it back in weekly segments.

Episode 11: Census Wrap-Up: Decade-by-Decade to 1790

In our first segment we welcome back genealogy researcher, author and lecturer Lisa Alzo. The author of Three Slovak Women, Baba’s Kitchen and Finding Your Slovak Ancestors talks about discovering family traits and putting them in perspective.

Then in our second segment we wrap up our three-episode coverage of U.S. census records with a decade-by-decade overview of censuses from 1880 back to 1790. We talk about special schedules taken during one or more censuses: mortality, slave, social statistics and supplemental, agricultural, manufacturing and the DDD (Defective, Dependent and Delinquent) schedules.

 Updates and Links

For a list of online resources for U.S. federal census data, check out the show notes for Episode 9 at http://tinyurl.com/ShowNotesEp9. More links you’ll want for this episode include:

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