Tag: 23andMe

Operating room Doctor or Surgeon anatomy on Advanced robotic surgery machine.

Protecting Consumer Privacy in DTC Tissue Testing

Adithi Iyer Leave a comment

By Adithi Iyer

In my last piece, I discussed the hypothetical successor of 23andme — a tissue-based direct-to-consumer testing service I’ve called yourtissueandyou — and the promise and perils that it might bring in consumer health information and privacy. Now, as promised, a closer look at the “who” and “how” of protecting the consumer at the heart of direct-to-consumer precision medicine. While several potential consumer interests are at stake with these services, at top of mind is data privacy — especially when the data is medically relevant and incredibly difficult to truly de-anonymize.

As we’ve established, the data collected by a tissue-based service will be vaster and more varied than we’ve seen before, magnifying existing issues with traditional data privacy. Consumer protections for this type of information are, in a word, complicated. A singular “authority” for data privacy does not exist in the United States, instead being spread among individual state data privacy statutes and regulatory backstops (with overlapping sections of some federal statutes in the background). In the context of health, let alone highly sophisticated cell signaling and microenvironment data, the web gets even more tangled.

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sample tube in female hands with pipette.

Why We Should Care About the Move from Saliva to Living Cells in Precision Medicine

Adithi Iyer Leave a comment

By Adithi Iyer

The cultural, informational, and medical phenomenon that is 23andMe has placed a spotlight on precision medicine, which seeks to personalize medical care to each patient’s unique makeup. Thus far, advances in direct-to-consumer genetic testing have made saliva-sample sequencing services all the rage in this space, but regenerative medicine, which relies on cells and tissues, rather than saliva, now brings us to a new, increasingly complex inflection point.

While collecting and isolating DNA samples from saliva may offer a wealth of information regarding heredity, disease risk, and other outflows of the “instruction manual” for patients, analyzing cells captures the minutiae of patients that goes “beyond the book” and most closely informs pathology. Disease isn’t always “written in the stars” for patients. Epigenetic changes from environmental exposures, cell-to-cell signaling behaviors, and the mutations present in diseased cells all profoundly inform how cells behave in whether and how they code the instructions that DNA offers. These factors are critical to understanding how disease materializes, progresses, and ultimately responds to treatment. This information is highly personal to each patient, and reflects behavioral factors as well as genetics.

Regenerative medical technologies use cell- and tissue-based methods to recapitulate, bioengineer, and reprogram human tissue, making a whole suite of sci-fi-sounding technologies an ever-closer reality. With cell-based and other regenerative therapies entering the market (making up an entire FDA subgroup), it well worth considering how cell-based medicine can advance the world of personalized consumer testing. In other words, could a corporate, direct-to-consumer cell-based testing service be the next 23andMe? And what would that mean for patients?

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DNA helix on colored background.

State Genetic Privacy Statutes: Good Intentions, Unintended Consequences?

The Petrie-Flom Center Staff Leave a comment

By Christi Guerrini, David Gurney, Steve Kramer, CeCe Moore, Margaret Press, and Amy McGuire

State legislators have enacted a flurry of genetic privacy bills that will strengthen the privacy and security practices of direct-to-consumer genetic testing companies and give customers more control over their data. What they might not realize is that these bills could be interpreted in ways that limit law enforcement’s ability to use a new technique that helps identify violent criminals and human remains and exonerate the wrongfully convicted.

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Illustration of a man and a woman standing in front of a DNA helix

A Proposal for Localized Review to Safeguard Genetic Database Privacy

Robert Field Leave a comment

By Robert I. Field, Anthony W. Orlando, and Arnold J. Rosoff

Large genetic databases pose well-known privacy risks. Unauthorized disclosure of an individual’s data can lead to discrimination, public embarrassment, and unwanted revelation of family secrets. Data leaks are of increasing concern as technology for reidentifying anonymous genomes continues to advance.

Yet, with the exception of California and Virginia, state legislative attempts to protect data privacy, most recently in Florida, Oklahoma, and Wisconsin, have failed to garner widespread support. Political resistance is particularly stiff with respect to a private right of action. Therefore, we propose a federal regulatory approach, which we describe below.

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Person typing on computer.

Online Terms of Use for Genealogy Websites – What’s in the Fine Print?

Jorge Contreras Leave a comment

By Jorge L. Contreras

Since genealogy websites first went online, researchers have been using the data that they contain in large-scale epidemiological and population health studies. In many cases, data is collected using automated tools and analyzed using sophisticated algorithms.

These techniques have supported a growing number of discoveries and scientific papers. For example, researchers have used this data to identify genetic markers for Alzheimer’s Disease, to trace an inherited cancer syndrome back to a single German couple born in the 1700s, and to gain a better understanding of longevity and family dispersion.  In the last of these studies, researchers analyzed family trees from 86 million individual genealogy website profiles.

Despite the scientific value of publicly-available genealogy website information, and its free accessibility via the Internet, it is not always the case that this data can be used for research without the permission of the site operator or the individual data subjects.

In fact, the online terms of use (TOU) for genealogy websites may restrict or prohibit the types of uses for data found on those sites.

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Graphical image of a genetic screen merging with algorithmic code

Do You Own Your Genetic Test Results? What About Your Temperature?

The Petrie-Flom Center Staff Leave a comment

By Jorge L. Contreras

The popular direct-to-consumer genetic testing site AncestryDNA claims that “You always maintain ownership of your data.” But is this true?  And, if so, what does it mean?

For more than a century, US law has held that data – objective information and facts – cannot be owned as property. Nevertheless, in recent years there have been increasing calls to recognize property interests in individual health information. Inspired by high profile data breaches and skullduggery by Facebook and others, as well as ever more frequent stories of academic research misconduct and pharmaceutical industry profiteering, many bioethicists and patient advocates, seeking to bolster personal privacy and autonomy, have argued that property rights should be recognized in health data. In addition, a new crop of would-be data intermediaries (e.g., Nebula Genomics, Genos, Invitae, LunaDNA and Hu.manity.org) has made further calls to propertize health data, presumably to profit from acting as the go-betweens in what has been estimated to be a $60-$100 billion global market in health data. Read More

Considering Direct-to-Consumer Genetic Testing? Spit with Caution

Gali Katznelson Leave a comment

By Gali Katznelson

A friend and I had been vaguely entertaining the idea of ordering genetic testing kits for some time. Then, Black Friday happened. My friend called me to share that 23andMe was on sale, 50% off, for 1 more hour! Typing our credit card information into Amazon, we tossed around some half-reasoned arguments in favor of our impulsive purchases: “this’ll be a fun science experiment”, “what if we catch something preventable in time to make lifestyle changes?” and, “we really should be contributing our data to research for the public good.” Within minutes, two kits were ordered and thanks to the magic powers of Amazon Prime, these boxes appeared on our doorsteps within days. Few things in life are as exciting as receiving a mail delivery, but as we unwrapped our packages, finding the words “Welcome to You” plastered on our shiny white Pandora’s boxes, somehow our excitement began to dwindle. One month later, our boxes remain unopened.

Genetic testing is clearly something we should have given more thought before the marketing geniuses got the best of us. Here are some questions anyone considering taking a direct-to-consumer (DTC) genetic test should answer (ideally before buying the test):

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The FDA Strikes Again: Its ban on home testing kits is, as usual, likely to do more harm than good

The Petrie-Flom Center Staff Leave a comment

Cross-post from PointOfLaw.

Richard A. Epstein is a professor of law at NYU Law School, a Senior Fellow at the Hoover Institution, a Senior Lecturer at the University of Chicago and a visiting scholar with the Manhattan Institute’s Center for Legal Policy. His forthcoming book is “The Classical Liberal Constitution,” from Harvard University Press.

On November 22, 2013, the Food and Drug Administration flexed its regulatory muscle by sending a warning letter to a genetic-testing company that goes under the stylish name of 23andme. The object of FDA scorn was a diagnostic kit that the tech company, backed by among others Google and Johnson & Johnson, sold to customers for $99. The kit contained an all-purpose saliva-based test that could give customers information about some 240 genetic traits, which relate to a wide range of genetic traits and disease conditions. The FDA warning letter chastised 23andme in no uncertain terms for being noncooperative and nonresponsive over a five-year period in supplying information that the FDA wanted to evaluate its product as a Type III device under the Medical Devices Act.

Legal Regulation of 23andme

There is no doubt that the FDA is on solid legal ground. This case is not like the processes involved in Regenerative Sciences, LLC v. United States, where the FDA asserted that physicians’ use of certain stem-cell procedures for joint disease involved the use of a drug that required FDA approval before it could be approved for use. In an earlier essay for the Manhattan Institute, I argued that this classification was in fact both legally incorrect and socially mischievous. In this case, the legal arguments are not available to 23andme because the current definition of “medical devices” covers not only those devices intended for use on the human body, but also those used for the diagnosis of disease. The Type III classification means that this device has to receive premarket approval from the FDA, which in turn requires that it be shown to be safe and effective for its intended use. Getting approval under this standard is arduous business, because any such approval must be for each of the tests separately. 240 tests thus require that number of approvals. The costs are prohibitive, and the delay enormous.

The FDA Warning Letter is significant both for what it says and for what it does not say. Read More

Dov Fox on the question of “designer babies”

Dov Fox Leave a comment

Bill of Health blogger Dov Fox was quoted in the recent article “Genetic-testing patent raises concerns about ‘designer babies’.”

“‘Some people might say this is in some respects similar to dating websites to the extent you look for traits in somebody you want to have children with,’ said Dov Fox, a law professor at the University of San Diego. But the important question, he said, is whether the accuracy from the genetic testing, albeit imperfect, makes 23andMe’s service more troubling.”

View the full article here.