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A screenshot from the HairDX Web site.
California Takes Action Against Genetic Testing Companies
by
Josh Katz
Monday marked a state-issued deadline requiring California companies to stop direct-to-consumer sales for genetic tests, with only one company, HairDX, complying with the order.
30-Second Summary
HairDX claims to assess a client’s risk of balding through the use of genetic tests. Following the advice of legal counsel, it has heeded the cease-and-desist letter that it received from the state's health department on June 9, and will now require California and New York residents to consult a doctor before ordering their tests.
California’s health department sent out the letters two weeks ago to 13 genetic-testing companies, requesting responses by June 23. Only four companies, HairDX, Navigenics, 23andMe and DNATraits, have confirmed receiving the letter, and HairDX is in the only one to comply so far.
Recently, genetic testing companies have garnered much attention, purporting to indicate a person’s genetic predispositions by mapping parts, and sometimes all of, their DNA. As prices drop below the $1,000 mark for some tests, states and medical professionals have expressed concern that people ordering tests on their own might make rash decisions with this newfound knowledge, including major lifestyle changes.
N.Y. State's Department of Health has also sought regulation of this new scientific field, threatening legal recourse to genetic testing-firms lacking permits.
“Overall, 24 states prohibit or limit so-called direct-access testing without a doctor or other medical professional's involvement,” according to Forbes.
However, Thomas Goetz of Wired contends that an individual’s genetic information should not be regulated by the state, however: “we neither want nor assume that doctors should have a gatekeeper role in establishing whether we are or are not pregnant… So too with DNA.”
California’s health department sent out the letters two weeks ago to 13 genetic-testing companies, requesting responses by June 23. Only four companies, HairDX, Navigenics, 23andMe and DNATraits, have confirmed receiving the letter, and HairDX is in the only one to comply so far.
Recently, genetic testing companies have garnered much attention, purporting to indicate a person’s genetic predispositions by mapping parts, and sometimes all of, their DNA. As prices drop below the $1,000 mark for some tests, states and medical professionals have expressed concern that people ordering tests on their own might make rash decisions with this newfound knowledge, including major lifestyle changes.
N.Y. State's Department of Health has also sought regulation of this new scientific field, threatening legal recourse to genetic testing-firms lacking permits.
“Overall, 24 states prohibit or limit so-called direct-access testing without a doctor or other medical professional's involvement,” according to Forbes.
However, Thomas Goetz of Wired contends that an individual’s genetic information should not be regulated by the state, however: “we neither want nor assume that doctors should have a gatekeeper role in establishing whether we are or are not pregnant… So too with DNA.”
Headline Link: ‘DNA Testing Company Stops Direct-to-Consumer Sales in California’
HairDX has stopped its direct-to-consumer sales in California. The decision “is a sign that the Public Health Department's cease-and-desist letters are already having an impact on the nascent genetic testing industry,” according to Wired.
Source: Wired
Background: California and New York tighten regulations
The AP reported on June 16 that, “California health regulators have demanded that 13 direct-to-consumer genetic testing startups halt sales in the state until they prove they meet state standards.”
Source: Condé Nast Portfolio
In mid-April, Forbes reported that the N.Y. State Department of Health sent letters to six genetic testing companies threatening fines and possibly jail time if there was no doctor involvement in requesting the tests. Even though many of the companies are based in California, the state of New York called for fines if its residents were tested.
Source: Forbes
Related Topic: The personal genetic testing phenomenon
On March 30, findingDulcinea reported on the rising popularity of personal genetic code mapping. Various companies provide individuals with the opportunity to learn about their DNA, for prices as low as $1,000. The tests reveal information such as an individual’s predisposition to certain diseases as well as what mates are most DNA compatible to them.
Source: FindingDulcinea
Opinion & Analysis: The genetic testing issue
The implications of genetic testing
Jason Kincaid of TechCrunch blog writes: “The fact of the matter is that genetic testing will be commonplace within the next decade, and the outcome of these cases will be setting important precedents.”
Source: TechCrunch
In the Genetic Future blog, genetic and evolutionary researcher Daniel MacArthur claims, “Naturally, this is just the beginning—to a large extent what's going on here is a turf war between proponents of the old-school medical regulation model and upstart advocates of the free information paradigm of the Google generation.”
Source: Genetic Future
Against California’s decision
In Wired, Thomas Goetz argues that, as complicated as the data may be, people are smart enough to handle the implications of their genetic information for themselves. “Frankly, it's insulting and a curtailment of my rights to put a gatekeeper between me and my DNA.”
Source: Wired
For California’s decision
Blogger Dr. Steve Murphy, a fellow in clinical genetics at Yale University, supports California’s decision to the tighten the leash on genome companies. “Medical genetic testing will and should fall in the realm of health care and practitioners,” he writes.
Source: Gene Sherpas
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