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Amid Hype, Questions Remain About Data Usage, FDA Regulation of Consumer Genomics Services

This story originally appeared in Biocommerce Week, a newsletter that has been discontinued.
 
Over the past week, two competing consumer genomics services offered by Decode Genetics and by privately held startup 23andMe were officially launched amid much hype and media attention, but questions remain about how the firms will make money off these services, if insurance companies will cover the services, and whether the US Food and Drug Administration will regulate them.
 
While the firms touted the opportunity they may provide consumers in understanding their personal genetics, neither firm has made financial projections or said whether they expect the ventures to be profitable.
 
The services are priced around $1,000, which could limit their potential subscriber base to more affluent customers. In addition, it is unknown whether insurance companies would ever be willing to pay for even part of these services.
 
These two factors raise the question of how these new offerings will pay for themselves. This question is particularly pertinent to 23andMe, which is privately held and doesn’t have any other commercial operations like Decode has.
 
23andMe, however, has received $3.9 million in funding from Google, as well as undisclosed investment funds from New Enterprise Associates, MDV-Mohr Davidow Ventures, and Genentech.
 
The last investor listed has led to some speculation that the genetic data collected by these firms could be sold to biopharmaceutical firms for use in drug research and development. While neither 23andMe nor Decode said that this was in their plans, 23andMe Co-founder Linda Avey said during a webcast this week, “we do plan to use the data that we’re collecting on our customers to improve our services.”
 
She added, “Beyond that … we do plan and our mission is to be involved with research and with the outside research community.”
 
Asked during the webcast if 23andMe would sell access to its database to medical researchers or others, Co-founder Anne Wojcicki said the firm would seek partnerships with academics and other groups, “but at no time will we be selling your individual data.”
 
The consent form for 23andMe informs customers that the firm may enter into partnerships with non-commercial or commercial entities that would grant those partners access to the firm’s database and other contributed personal information “after such organizations agree to maintain confidentiality consistent with our privacy policy.” The firm stresses, however, that these collaborators would not have access to personal account information, such as contact and payment information.
 
23andMe officials declined to answer specific questions from BioCommerce Week, and pointed to the firm’s website and webcast for information about the service.
 
Wojcicki said during the webcast that the firm is working with a “number of individuals at an early stage right now. I think that there’s been some mention that we have been talking to some groups in autism and Parkinson’s research,” but the firm does not have “any significant research projects underway right now,” she said.
 
“Our aim is to be as transparent as possible if we can with these research studies so that people know exactly what we are doing and that there is accountability,” said Wojcicki.
 
Meanwhile, Decode could use the data in-house in its own drug research. The firm also did not respond to e-mails from BioCommerce Week by press time, and did not specifically address this issue during its webcast.
 
The issue of whether insurance companies will cover these services in the future is also up in the air.
 
“We cannot comment right now on what insurance companies may or may not do,” said Wojcicki. “It is not something that we’re doing right now. But we will keep you posted if anything changes on that.”
 
Another question hanging over these new offerings is whether the FDA will determine that these services will need to be regulated. Both 23andMe and Decode officials stressed that they are not offering consumers genetic tests — such as those offered to consumers by DNA Direct.
 
“We can’t really speak to how the FDA is going to respond, but what we can tell you is that we feel very strongly that we also … are very aligned with the FDA and that we want to do things that are for the good of society and for the benefit of genetic research,” said Linda Avey, co-founder of 23andMe. She added that the firm would remain close to “all of the stakeholders in this area,” to try and ensure the firm is “aligned with all of the objectives and the principles of these bodies.”
 
The DecodeMe website likewise tells potential subscribers that the service is not offering genetic tests.
 
“We strongly encourage you not to use this to make medical decisions,” Decode CEO Kari Stefansson said during the webcast. “If there is something that raises concerns when you look at your result …you can ask a question that will be answered by our experts.” The firm may also refer subscribers to a genetic counselor.
 
However, genetic testing, and direct-to-consumer genetic testing in particular, has come under increased scrutiny over the past year and a half. Last year, the US Food and Drug Administration, the US Federal Trade Commission, and the US Centers for Disease Control and Prevention issued a joint statement warning consumers of some of the pitfalls of at-home genetic testing — including DTC pharmacogenomic testing.
 
Although the statement acknowledges that DTC companies’ pharmacogenomic claims are based on trustworthy science, it warns consumers not to act on that information alone. At-home tests that can give information about a person’s response to certain drugs “are not a substitute for a physician’s judgment and clinical experience,” the agencies said.
 
“At some point regulatory oversight makes some sense because you need to justify to at least somebody that what you’re looking at really does what you say it does,” said Harry Glorikian, managing partner of life science consulting firm Scientia Advisors.
 
“I don’t know when somebody over there [at FDA] says, ‘OK, you’ve crossed that fine line,’ whatever that fine line is, because it is still being defined,” he told BioCommerce Week. However, “They do not want to come out and quash this out of the gate.”
 
Sizing Up the Services
 
Last week, Decode launched its DecodeMe subscription service, which uses a cheek-swab sample and a password-controlled personal account to give customers analysis about their own genomic information, including knowledge about genetic variants associated with risks for common diseases, ancestry, and traits such as hair and eye color.
 
While a few media outlets last week reported that Illumina would provide the genotyping tools for the service, neither Decode nor Illumina would confirm this. The firms have an alliance dating back to the spring of 2006 to co-develop and commercialize DNA-based diagnostics using Illumina technology.
 

“Our aim is to be as transparent as possible if we can with these research studies so that people know exactly what we are doing and that there is accountability.”

“We are using all kinds of technology with this,” Stefansson told BioCommerce Week sister publication BioArray News this week. “We don’t want to be dependent on one supplier of technology. Therefore we are not solely going to be dependent on one manufacturer because in the end when you have large volume the technology can vary.”
 
Decode is offering its services at an early promotional cost of just under $985. Stefansson said during a webcast that although the firm hasn’t set a firm date for the end of the promotional period, “it is likely that is going to be at the end of December. Then what the price going into the future will be will depend a little bit on the response that we get to this.”
 
Stefansson pointed out Decode’s history in the genomics field as a key competitive advantage over the other services.
 
“Some of the genes that our competitors are using were discovered by us,” Stefansson told BioArray News. “Some of the competitors give off the impression that all you have to do is put up a playful website to perform this kind of service." 
 
The company also sees its track record in handling data as an asset. “The difference between us and [our] competitors is that when it comes to genotyping large amounts of people it is not a trivial matter,” he said. “We have genotyped thousands of people over the past 10 years. We have our own private encryption system. We come into this game not only with an idea and technology, we have come in with an unusually strong track record,” said Stefansson.
 
23andMe
 
The 23andMe service, which was announced earlier this week, is very similar to the Decode service. The web-based service uses Illumina's genotyping platform and chips with more than 600,000 SNPs on them to analyze a DNA sample from saliva that the customer provides. The genotyping takes place an outside lab contracted by 23andMe, company officials said during a webcast.
 
Customers of the service use 23andMe’s web tools and analysis to learn about their genomic profiles and gain information about their ancestry.
 
“We’ve worked closely with Illumina to develop customized content that gives you information immediately that you will find useful,” said Wojcicki during the webcast.
 
While the service is only available in the US to start, 23andMe does intend to offer it internationally soon, said Avey.
 
Though the service is initially priced at $999, “We would anticipate that technology costs would keep dropping,” said Wojcicki. “So, over the next few years we really hope that this service becomes less expensive.”
 
Navigenics
 
A third firm, Navigenics, which is billing itself as the “responsible” personal genetics firm that is building genetic counseling centers across the US, launched its service Nov. 12 and became the first company to officially begin taking orders, though it will not actually begin delivering its $2,500 service until early next year. 
 
Unlike 23andMe, the firm will use Affymetrix's genotyping technology.
 
The pact with Affymetrix was disclosed by Affy President Kevin King at the UBS Global Life Sciences Conference in New York in September (see BioCommerce Week 9/26/2007).
 

He said that consumers will be able to go to the Navigenics website and order a saliva collection kit. The customer will then send the kit to Affymetrix’s CLIA lab, which will run a whole-genome screen and send the analysis to Navigenics. Then, Navigenics will provide the genetic-predisposition analysis to the customer via a secure, private web portal and offer genetic counseling.

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