LEHI If given a chance, who wouldnt want to spend a few bucks to find out if theyre at heightened risk for one day having to confront some life-changing or life-ending medical malady?
Thats the concept fueling an explosion in direct-to-consumer genetic testing and one thats also elevating ethical debates about how this most personal of information should be interpreted and protected.
Utah-born Ancestry.com is the latest entry into a growing list of companies offering health-focused genetic testing an industry expected to grow to $20 billion annually in the next few years.
While best known and an industry leader for its expertise in providing answers to the Where am I from? question, Ancestry will now expand its genetic testing resources to help people anticipate future health issues and help address, Whats going to make me sick?
Last week, the company that launched more than 30 years ago as a family history search service, later adding DNA testing to help customers identify their geographic ancestral roots, announced its new, health-focused genetic testing service.
AncestryHealth will offer two levels of genetic testing that the company said will deliver actionable insights that can empower people to take proactive steps in collaboration with their health care provider to address potential health risks identified in their genes and family health history.
Ancestry CEO Margo Georgiadis said the new genetic tests will help clients proactively manage their health care needs, armed with new insight on what conditions they may be predisposed for, based on genetic evidence.
Your genes dont need to be your destiny, Georgiadis said in a statement. Understanding your familial and inherited health risks can help you take action with your doctor to improve your chances of better health outcomes.
For more than three decades, Ancestry has empowered journeys of personal discovery to enrich lives. In the same way that knowledge of your family and ethnicity helps you understand your past to inspire your future, knowledge of your genetic health profile and any associated risks can help you be proactive in managing the future for you and your family.
The two testing products, according to the company, include AncestryHealth Core, which uses the companys current genotype genetic assessment technique to detect genetic differences and deliver personalized reports related to health conditions such as heart disease, hereditary cancers, blood-related disorders, and risks for carrier status of health conditions, such as Tay-Sachs disease. The one-time test costs $149 and also includes the companys family history report. Those who have already submitted a biologic sample to the company can get the new genetic report for $49.
While likely not available until sometime in 2020, the AncestryHealth Plus will use more current, genetic sequencing technology that will provide greater coverage of DNA differences for each condition and more risk categories such as those related to potentially developing heart disease, cancers, and disorders related to blood, the nervous system and connective tissues. The sequencing test will require a $199 activation fee, which the company said includes the first six months of membership and an additional $49 membership fee every six months. Existing Ancestry customers will be able to upgrade to AncestryHealth Plus for an initial payment of $49.
Ancestrys testing regimen will assess genetic samples and indicate predispositions for high cholesterol and cardiomyopathy, which can lead to heart disease; hereditary indicators for breast, ovarian, colon and uterine cancers; and blood disorders including abnormal clotting and iron overload. The testing can also determine if the sample donor is a gene carrier for cystic fibrosis, sickle-cell anemia or Tay-Sachs disease, a fatal nervous system disorder that most commonly occurs in children.
Unlike its competitor, 23andMe, which has earned U.S. Food and Drug Administration approval for providing genetic test results directly to customers without a physicians participation, Ancestrys genetic testing service requires a physicians order to conduct the tests and the company says it has contracted with a private network of independent physicians and genetic counselors who participate in the process. Ancestrys health testing service also connects customers to educational information, including access to genetic counseling resources and provides printable and consumer and physician-ready reports that provide guidance for next steps an individual and their health care provider can take together.
Lynn Jorde, chairman of the University of Utahs Department of Human Genetics and executive director of the Utah Genome Project, said while labs are now capable of sequencing the entirety of the human genome some 3 billion genetic basis pairs the microarray technique currently used by Ancestry evaluates a small window of genes that, if a variation is found, have a viable medical response.
What theyre looking at is specific changes in the DNA that we know about in specific instances ... and are often called actionable genes, Jorde explained. If you have a disease causing variant here, there is actually something we can do about it.
Jorde said while some genetic markers, like those for cystic fibrosis, indicate a high probability that you have or will develop that condition, many more are merely suggestive.
The predictive power of genetic testing is getting better and better, but it will never be perfect, Jorde said. For many of these conditions, there are nongenetic components that impact risk.
Jorde said things like environment, diet and exercise/activity level can play a significant role in an individuals risk of developing an illness or disease.
Teneille Brown is a professor at the University of Utahs S.J. Quinney College of Law and an expert in health law and medical ethics. In an interview, she noted direct-to-consumer genetic testing services, now being offered by dozens of companies according to the National Institute of Health, are occupying a space thats in between current regulatory boundaries aimed at protecting individuals privacy rights.
In the research realm, any federally funded projects are subject to stringent privacy rules, Brown said. That is also the case for health care institutions that handle genetic material, under (Health Insurance Portability and Accountability Act) rules.
But the big databases being built by testing companies are outside of the federal funding process and are not health care providers, so the HIPAA rules dont apply, Brown said.
Ancestry appears to underscore this by noting, in its user agreement, that it is not a covered entity under HIPAA rules.
Brown noted that in addition to unanswered questions about privacy protections, genetic test results can lead to deep emotional impacts for tested individuals, either through the discovery of gene markers that are suggestive of some future medical challenge or, less obviously, when a clean test is returned, which may provide an inaccurate suggestion that theres nothing to worry about.
Theres a huge problem when it comes to understanding what these risk scores mean, Brown said. The predictive values of these results is widely variable, including what is, or is not, implied by failure to find a specific marker.
Brown said genetic testing companies have wide-ranging policies regarding sharing an individuals genetic test results or stored biologic samples with third-party researchers. Ancestry, for example, says it will only share your information if youve given them specific permission to do so, through its informed consent agreement.
While the regulatory world is lagging behind the fast-moving development of genetic testing technology, Brown said she believes the bigger companies, including Ancestry, are working to create appropriate protections for their customers. And, she added, the growing body of knowledge being accumulated by this work could lead to groundbreaking advancements in treatments for serious diseases.
These companies might play a role in developing amazing drugs and therapies, Brown said. Collectively, they are adding all of this amazing content, providing pedigrees and information and incredibly powerful databases ... and a lot of good can come of it.
Its not at all sinister, but we need consumers to know what theyre submitting and being diligent about potential secondary uses of that data. More robust consent requirements for users and strict limitations for secondary uses are certainly in order.
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