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Tag Archives: DTC Genetic Testing

New York Times’ Brody Counsels DTC Genomics Caution

An article in yesterday’s New York Times calls direct-to-consumer genetic testing, a trend we are following on this blog, “fraught with potential dangers.”  Although our original post on the subject discussed many of the regulatory and ethical issues around DTC genomics, Brody’s article raises some interesting additional points:

  • The risk of false reassurance: “a man told he lacks genes linked to an elevated risk of heart disease might decide to smoke, eat lots of salt and saturated fats, avoid exercise or develop a large paunch.”
  • The article also notes privacy risks, citing Lori Andrews’ comments that “[s]ome companies are just a front end for biotech companies that use it for research.”

Brody is reluctant to confer even a label of “relatively harmless” on the current technology, but the article will probably drive further awareness and additional interest.

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Trends Update — DTC Genetic Tests: NOVA ScienceNOW Program Takes a Look

B&W_DNA_sequenceYesterday’s NOVA ScienceNOW program included a segment on direct-to-consumer genomics (H/T to GenomeWeb’s Daily Scan Blog).  The program was bullish on George Church’s Personal Genome Project; but it took a pretty dim view of the predictive value of current consumer technology.

The program was accessible and interesting, but it went overboard in making a cautionary point about current DTC genomics offerings.  It transitions directly from Neal deGrasse Tyson’s 23andMe results for heart disease and diabetes to Steven Pinker’s genomic scan, which showed that Pinker had “double the risk of baldness,” whereas Steven is anything but bald.  Well, sure, and the weather report yesterday said there was an 80% chance of rain but it didn’t rain.  That doesn’t mean I should stop checking weather reports, or even that I was stupid to pack an umbrella.  It’s just probabilities.  I guess I agree with the program in the sense that anyone who can’t spot that flaw shouldn’t be interpreting their own genomic data, but it seems like an oddly condescending way for them to make the point.

Kudos, though, for pointing out:

  1. the gaps in the Genetic Information Nondiscrimination Act; and 
  2. the low risk to tenured Harvard profs of revealing their sequence data, as they are likely shielded from many of the risks to other participants.

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Trends Update — DTC Genetic Testing: Survey of State Laws on False Advertising

B&W_DNA_sequenceOne aspect of direct-to-consumer genetic testing that requires particular vigilance is the “consumer” aspect.  We should expect that as the underlying technology becomes cheaper and testing companies proliferate, there will be more who prey on insecurity and health fears to make a quick buck while providing little value (or worse, missing genuine concerns).

GenomeWeb Daily News today notes a survey of state “false advertising” laws (pdf) conducted by Anya Prince, a student with the Georgetown University Law Center’s Harrison Institute for Public Law.  At the moment, the survey reports, there are no state laws specific to genetic testing.  However, the survey does identify various generic false advertising laws that could apply if DTC providers make false or misleading claims.  As GenomeWeb notes, the Federal Trade Commission has already shown an interest in policing the area.  Together with the CDC, they put out a flyer in July 2006 on DTC genetic tests for consumers, advising that the tests are only truly valuable if interpreted by a doctor or trained counselor.

Some skeptics note that the value of tests for genetic predispositions is minimal.  Even without a genetic test, we know that if we want to avoid heart disease we should eat well and exercise.

Similarly, even without specific laws aimed at genetic shenanigans, we already know that providers who want to avoid liability should, in their literature and in their contracts, be honest with their customers about what the results do and do not mean.

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Trends in 2009: Direct-to-Consumer Genetic Tests Come to Canada

B&W_DNA_sequenceThis week saw the introduction of what I believe is Canada’s first personal genomics service offering.  Toronto’s Medcan Clinic paired up with California-based Navigenics to scan individuals’ genomes for a variety of disease markers.

Personal genomics is a burgeoning trend this year, which according to a special report in April’s Economist, will only be further boosted by a Moore’s Law-type improvement in sequencing power and price.  Available service offerings range from whole genome sequencing (e.g., Illumina and Knome) that costs tens of thousands of dollars to targeted scans typically offered for under $500 by a much wider variety of providers (Navigenics, 23andMe, deCODE and Pathway Genomics).

Regulation of DTC Testing:

In the U.S., the regulatory environment has settled down somewhat over the last 6 months, with most U.S. states regulating DTC genetics companies as clinical labs and the providers registering as such on a regular basis, including CLIA certification.  However, the HHS Secretary’s Advisory Committee on Genetics, Health and Society is due to meet in October to further discuss whether DTC genetic tests should be regulated as medical devices.  The CDC has released a report entitled “Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions” setting out best practices both for testing and interpretation.

In Ontario, there are a number of regulatory considerations (thanks on these points for input from Will Chung, of our renowned Life Sciences team):

  1. Private labs and specimen collection centres require licenses and are governed by the Laboratory and Specimen Collection Centre Licensing Act (LSCCLA). However, blood collection at such facilities is governed by separate legislation which controls who may draw blood and for what purpose.
  2. The LSCCLA requires that only “legally qualified medical practitioners” are permitted to examine specimens, which means that patients may not directly order testing of their own blood at private licensed labs.
  3. Ontario’s Regulated Health Professions Act stipulates that communicating a “diagnosis” is a “controlled act” which may only be performed by a person authorized by a health profession Act, although it is not clear that DTC genomics results are a “diagnosis.”

Medscan seems to have navigated the regulatory waters, but time will tell how these laws are applied and/or modified.

In the EU, the European Society for Human Genetics advocates for pre-market review for “truthful labeling and promotion” as well as post-market evaluation of DTC genetic tests. In May, Germany passed a law restricting the availability of DTC genomics services by requiring testing to be carried out by a licensed doctor following the patient’s consent.”

How much protection do consumers need?

Many commentators are concerned with the public’s ability to understand these tests and distinguish between those that are clinically meaningful and those that are more … snake-oily.  Others object on the basis that there is little value added absent any available treatment — many preventive measures are things we already know we should do, like eat well, exercise, etc.  A number of groups, including advocacy group Genetic Alliance and the Genetics and Public Policy Center at Johns Hopkins University have called for a national registry of DTC genetic tests that would include performance data.

Others (and not just 23andMe’s founders) take a more libertarian view.  Ronald Bailey, the science columnist at Reason, agrees that people probably don’t need to be “protected against learning such information without the guidance of a knowledgeable physician or genetic counselor.”  In fact, a lawsuit in May brought by a girl born with Fragile X syndrome against the sperm bank that didn’t test for the predisposition may drive  higher demand for genetic testing in the fertility context which may in turn drive supply of services and diagnostic tools and may contribute to normalizing broader parental testing and pre-implantation screening.

Interestingly, a NEJM report a couple of weeks ago showed no lasting psychological damage from a genetic prognosis of increased Alzheimer’s risk.  By the time a year passed after the results, subjects who had an increased Alzheimer’s risk were no more depressed, anxious, or distressed than when they started the study.

Most importantly, 98% of patients in the Alzheimer’s study who tested positive said they would still get tested if offered the choice again.  98% is a lot. It suggests that DTC services will be increasingly popular, particularly as the price drops and the quality of the data, the analytics and the available counseling continue to improve.

Stay tuned to this page for further DTC genetics news and analysis.

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