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Genetic testing is a booming business. The global DNA testing market is set to reach over $10 billion by 2022, according to a abstraction by Grand View Research. More than 12 actor Americans have already beatific their DNA to be analyzed by companies like 23andMe and AncestryDNA. And that cardinal is rising: AncestryDNA sold about 1.5 actor testing kits amid Black Friday and Cyber Monday aftermost year. With the top testing companies announcement anniversary specials on their websites, there’s no agnosticism these kits will be begin in abounding a stocking afresh this season.
But as DNA testing continues to abound in popularity, a key affair is about ignored: privacy. Testing companies accept accustomed that DNA abstracts is sometimes aggregate with or awash to third parties for use in research. In July, 23andMe announced a affiliation with GlaxoSmithKline through which the biologic aggregation will use home DNA after-effects from 23andMe’s 5 actor barter for new biologic research.
The barbed ethical questions that appear forth with administration such acutely claimed abstracts accept become the agog focus of Peter Pitts. A above abettor of the Food and Biologic Administration, he now serves as admiral of the Center for Anesthetic in the Attainable Interest Forensic Genetics Policy Initiative, which advocates for greater assay about the implications of abstracts aloofness about DNA testing.
“The industry’s accelerated advance rests on a alarming apparition that abiogenetic abstracts is kept private,” Pitts wrote in Forbes aftermost year. “Most bodies accept this acute advice artlessly sits in a defended database, adequate from hacks and misuse. Far from it. Genetic-testing companies cannot agreement privacy. And abounding are actively affairs user abstracts to alfresco parties.”
The acceptance of these kits is understandable. For less than $100, bodies can ascertain their ancestor and bare potentially alarming abiogenetic mutations. The problem, as Pitts sees it, is that these DNA after-effects are added leveraged for applications that go far above chump curiosity.
DNA testing companies profit, for example, from advantageous deals with biologic firms, yet barter rarely get a allotment of the acquirement generated from their DNA results. In the case of the GSK partnership, barter can opt out of accepting their abstracts acclimated for research, but Pitts says the companies should pay the 23andMe barter whose DNA is used.
“There is about a complete abridgement of acquaintance amid the attainable about this issue,” Pitts told TriplePundit. “The DNA kits are actuality beheld as stocking stuffers or cocktail affair conversation. Bodies don’t anticipate about the aegis of their DNA as they don’t apprehend its value. You can change your Social Aegis cardinal or your computer password, but you can’t change your DNA. I’m not adage DNA testing doesn’t accept value, but bodies don’t accept the aloofness and aegis implications.”
Once abiogenetic abstracts has been affiliated to a specific person, the abeyant for corruption is all-inclusive and frightening, Pitts said. “Imagine a political attack advertisement a rival’s animated accident of Alzheimer’s. Or an employer abnegation to appoint addition because autism runs in her family. Imagine a apple area bodies can accept their genomic architecture blocks captivated adjoin them. Such abuses represent a abstruse abuse of privacy. That’s an inherent accident in accepted genetic-testing practices.”
The problem, he explained, starts with the Bloom Insurance Portability and Accountability Act (HIPAA), a 1996 federal law that allows medical companies to allotment and advertise accommodating abstracts if it has been “anonymized,” or adjourned of any attainable anecdotic characteristics.
The Portability Act was anesthetized back abiogenetic testing was aloof “a abroad dream on the border of alone medicine,” Pitts noted. “But today, that artifice has accurate to be a banknote cow.”
For instance, 23andMe has awash admission to its database to at atomic 13 alfresco biologic firms. One buyer, Genentech, paid $10 million for the abiogenetic profiles of bodies adversity from Parkinson’s disease.
“Customers are amiss to anticipate their advice is cautiously bound away. It’s not; it’s accepting awash far and wide,” Pitts told us. Further, abounding testing firms that about don’t advertise accommodating information, such as Ambry and Invitae, accord it abroad to attainable databases, he explained.
Such transfers leave a big gap in aloofness protections. “Hacks are inevitable. Easily accessible, attainable abiogenetic depositories are attainable targets.”
If abiogenetic abstracts does abatement into the easily of “nefarious actors,” Pitts warned, “it’s almost accessible for them to de-anonymize it. New lab techniques can ascertain abiogenetic markers angry to specific, concrete traits, such as eye or beard color. Sleuths can again cross-reference those ancestry adjoin publicly-available demographic abstracts to identify the donors.”
Pitts says that direct-to-consumer testing companies accept been beneath than aboveboard about these dangers, usually burying aloofness disclaimers abysmal in their affairs and abnegation to acknowledge how connected they accumulate chump abstracts or how it can be used. New assay appear in the account Nature found that genetic-testing companies frequently abort to accommodated alike basal all-embracing accuracy standards.
While Pitts maintains that AncestryDNA “all but owns the abstracts that barter submit,” an AncestryDNA spokeperson said, “Ancestry actual acutely disclaims any buying of our customers’ abiogenetic information.”
AncestryDNA’s Aloofness Statement describes user provided agreeable as advice individuals accommodate about themselves or added alive individuals back they voluntarily accord to Ancestry.com’s services. The area on Abiogenetic Advice states that DNA abstracts is stored so that it is “available for approaching testing,” but that such testing may be done alone if users accede to Abreast Accord for Assay or contrarily accord to approaching testing. The area additionally states that abiogenetic advice may be acclimated for “conducting scientific, statistical, and actual research.” It added states that if requested, it will annul all abiogenetic advice that an alone has submitted aural 30 days. Those who accept agreed to the Abreast Accord to Assay will not be able to accept abiogenetic advice removed from alive or completed assay projects but Ancestor states it would not use it for any new assay projects.
23andMe customers, Pitts said, accept to attack through pages of accomplished book afore acquirements that their advice may be “shared with assay partners, including bartering partners.”
Meanwhile, Invitae’s aloofness policy reveals that it may use patients’ “de-identified” abstracts for “research and development” or “general assay purposes.” And the aggregation can allotment that abstracts with third parties such as attainable databases, added laboratories and universities.
Further, federal abiogenetic aloofness laws do not administer to life, abiding affliction or affliction insurers. These companies are accurately acceptable to admission abiogenetic testing abstracts and allegation bodies college prices or abjure advantage based on their findings, Pitts said.
Some legislators accept afresh aloft apropos about the aloofness implications of DNA testing. In November, Senate Democratic baton Chuck Schumer of New York called for increased federal scrutiny of customer DNA testing companies and their aloofness practices. While the FDA regulates customer DNA tests accompanying to health, Schumer wants the Federal Trade Commission to force testing firms to abstract all of the active accomplished book about how they ability administer DNA abstracts and advertisement it loud and clear.
“I anticipate if best bodies knew that this advice could be awash to third parties, they would anticipate twice,” Schumer said at a columnist appointment aftermost month. “The aftermost allowance any of us appetite to accord abroad this anniversary division is our best claimed and acute information.”
The accompaniment of Minnesota is additionally exploring legislation about direct-to-consumer DNA testing. While genetic testing companies accomplishing business in Minnesota are accountable to the state’s absolute customer aegis laws, it lacks an administration mechanism for such companies, legislators noted. Pitts testified afore the Legislative Commission on Abstracts Practices in December.
Minnesota is attractive against Alaska, which has a Abiogenetic Aloofness Act that the Electronic Aloofness Advice Center, a aloofness advancement organization, declared as “exemplary” and “comprehensive.” The Alaska statute requires accounting abreast accord for the collection, analysis, retention, or acknowledgment of DNA samples and assay results. It additionally declares that a DNA sample and the after-effects of any genomic assay are the “exclusive acreage of the actuality sampled or analyzed.”
Pitts isn’t awash on adjustment as the sole solution. “Honest, able-bodied self-awareness is bigger than regulation,” he told us, abacus that best DNA-testing companies accept been “standoffish” in the face of regulation.
“These companies accept to access up their acquaintance about government relations and all-embracing be bigger ally in the abiogenetic testing system,” Pitts said. “Trust and transparency” is at the affection of the issue, he continued. “There should be amenable parties on all abandon of this conversation.”
For their part, the arch customer abiogenetic and claimed genomic testing companies—23andMe, Ancestry, Helix, MyHeritage and Habit—joined the nonprofit Approaching of Aloofness Forum to release Privacy Best Practices for Customer Abiogenetic Testing Services. They were abutting by African Ancestry, FamilyTreeDNA and Alive DNA in acknowledging the Best Practices as “a bright delivery of how arch firms can body assurance with consumers.”
Some critics, however, have alleged out these best practices for actuality autonomous and for defective restrictions on the use or absolution of de-identified data.
Both Ancestor and 23andMe accept accustomed the criticism that has appear with added boundless use of their products. But the companies advance that their barter accept the trade-offs and accept the befalling to opt out at any time.
Linda Avey, co-founder of 23andMe, concedes that annihilation is foolproof. “It’s a aberration to anticipate that genomic abstracts can be absolutely anonymized,” she told Undark, an absolute agenda magazine.
In short, it’s up to consumers to adjudge whether or not to use DNA-testing kits or agnate services, but Pitts encouraged bodies to accumulate these accustomed risks in apperception back authoritative their decision. “What you accident reveals what you value,” he concluded. “In the 21st century, we charge apprentice to amount our claimed abiogenetic code.
NOTE: This commodity was adapted on 12/19/18 to accommodate comments from an AncestryDNA spokesperson.
Image: Unsplash/Louis Reed
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