How Veritas Genetics Plans to Make Its $999 Whole Genome Stick
By Aaron Krol
March 28, 2016 | This month, Veritas Genetics, a DNA testing company based in Cambridge, Mass., began taking orders for its $999 myGenome service. Customers will mail saliva samples to the Veritas lab, where their DNA will be extracted and their entire genomes sequenced. The service includes a report on any genetic variants Veritas finds that could affect customers’ risks of developing serious diseases, or have other implications for their lifestyle and health.
It’s very similar to the product that the FDA forced 23andMe to stop selling in 2013. 23andMe, however, only scanned the genome for select variants at certain hotspots. (It still does, although these days the FDA only lets the company report on the health implications of a small handful of those variants.) The myGenome service goes much further.
“We’re pushing the boundaries,” says Preston Estep, Veritas’ Chief Scientific Officer. “We’re definitely providing more value than anybody else.”
In fact, the myGenome service is a steal. Although the company’s executives don’t say so directly, $999 is well below cost. Veritas owns a HiSeq X Ten system, a $10 million investment that can sequence DNA faster and more efficiently than anything else available. But between the capital costs of owning the machinery, and the disposable and labor costs for each sequencing run, the company would need to churn through around 18,000 genomes a year just to break even at the price it’s charging. “We need to feed the beast,” says Estep. “We’re just now starting to offer whole genomes. We’re sequencing the first few hundred right now, and by the end of the year we’ll have a few thousand.”
And the HiSeq system only gets Veritas raw data. After it spits out its mishmash of random genetic code, the company has to pay for the computational systems to order that data and find the genetic variants inside it. Then it has to make some sense of those variants, searching through big public databases to figure out if any have been identified as disease-causing or otherwise relevant to health. The process can be partly automated, but only partly; potential hits need to be checked by trained scientific staff, another big cost.
So it makes sense that the only other company to put a whole genome report on the general market, Sure Genomics of Salt Lake City, Utah, charged a much steeper $2500. (Sure Genomics got a letter from the FDA this February notifying them that the product may not be in regulatory compliance. See correction 3/29/16.) To make myGenome viable, Veritas will need to reach huge volumes of customers and still find extra services to sell them.
“We anticipate that there will be an ongoing relationship with the client, and we will layer on other -omics over time,” says Mirza Cifric, the CEO, using a term for large-scale biological measurements. “Think about amortizing a human genome over somebody’s lifetime. I think there are plenty of returns on that investment, given the fact that it doesn’t change and it’s there for reinterpretation as needed.”
In other words, Cifric wants customers to feel a lifelong attachment to learning more about their genomes. Veritas currently has a partnership with WorldCare International, a network for medical specialists, to offer a free genetic counseling session to each customer and additional sessions for a fee. It might also add new interpretation services, or layer on additional data like analyses of customers’ gut bacteria.
For now, though, Veritas is sequencing whole genomes at the lowest price it can offer, just to get customers in the door.
“We just realized that that’s where the puck is going to be,” Cifric says. “We said, what is the reasonable price for a genome? When does it become viable?”
A Perilous Business
In a way, it’s incredible that services like myGenome keep sprouting up. Not only are the margins painfully small―if not, in fact, negative―but the work is demanding and the regulatory risk huge. Cifric admits he’s worried about FDA actions like the one against Sure Genomics last month. There are a few big companies looking into ways to make money off the genome―sequencing giant Illumina and the oddball Human Longevity, Inc., are both tinkering with their own twists on the idea―but in general, whole genome testing is not a business for hard-nosed capitalists. Instead, it tends to attract idealists.
“What really excites me is a future where people have their whole genomes sequenced,” Cifric says. “So that’s out of the way. And my hope is that we’ll start seeing this trend where the genome is used beyond the disease and the disease risk, for many important lifestyle choices that ultimately do lead to better longevity and quality of life.”
It is nice to think we could get the genome out of the way. Targeted sequencing tests are growing more common: Veritas already sells one of the most popular kinds, testing a panel of genes that sometimes harbor cancer-related mutations, including the notorious BRCA1 and BRCA2. If you expect to have just two or three of these tests done over your lifetime, you might well be saving money by doing your whole genome in advance. And given the American healthcare system’s woeful inability to share data, there’s a good argument to be made for buying that genome yourself, so you can take the information wherever you get care.
The trouble, as the Veritas team well knows, is that we are still in the middle of a long and awkward transition phase, when few people are likely to get clear health advice from their genomes. “For the foreseeable future, clinical interpretation is going to be an uncertain game,” says Estep. “And when I say the foreseeable future, I mean even ten years from now. There’s going to be a lot that lies in the gray area.”
This is exactly what the FDA is worried about, and reassuring the agency will involve a combination of careful regulatory two-steps and personal judgment. Not claiming to diagnose disease helps; if Veritas finds anything particularly alarming, it offers a genetic counseling session and urges customers to get a targeted test to confirm. “It is not a clinical genome,” says Estep. “It’s more like a pre-screening.”
Physician involvement is also crucial, although one gets the impression Veritas sees this at least partly as a sop to the FDA. People who want to order myGenome have to do so through their doctors, which means the service is not a “direct-to-consumer” test subject to FDA regulation. Veritas takes this a little more seriously than some other genetic testing companies―it doesn’t have its own network of doctors to route potential customers through―but Cifric is unsure whether this will be a permanent feature of myGenome. Someday, he thinks, regulators may trust both consumers and providers enough to let people order their tests directly.
“If we can persuade the regulatory authorities and the medical community that, on the back end, we are doing it the way that they expect it to be done,” he says, “that it is reported in a way that doesn’t overly concern people, that it creates true opportunities for impact on life… I hope that after this transitional period, we can relax things on the front end.”
The Personal Genome
The team at Veritas has a lot of faith that ordinary people can cope with the information in their genomes, including disease risks that may sound very serious. Much of the company’s leadership―including Estep, founder George Church, and Chief Medical Officer Joseph Thakuria―are involved in the Harvard Personal Genome Project (PGP), which for more than a decade has not only sequenced hundreds of volunteers’ genomes, but also made them fully public. Although Veritas has no formal connection to the PGP, some of the software engineers from that project have migrated to the company, and so has an ethos of being upfront about the limitations of genetic testing.
“Genetics is a complicated and messy science,” Estep says. “Rather than just selling a test, we’re trying to provide an educational experience.”
Among the results included in a myGenome report might be variants that affect cancer risk, cardiovascular health, neurological disease, and sensitivity to certain drugs. Some of these risks will be serious and well-established, but most will be marginal; some variants will only have been seen once or twice before, or may only resemble known mutations. A few will confront customers with harsh realities, like variants in the gene APOE that greatly increase the risk of Alzheimer’s disease.
Veritas won’t recommend any specific medical treatments, but it will try to make lifestyle suggestions where they’re relevant.
Giving customers useful health advice is difficult for genetic testing companies, in part because the most important healthy behaviors are a good bet regardless of what’s in your genome. “What we don’t want to do is get a genome done, and the answer is eat better and exercise more,” says Cifric. “That’s not going to do for our industry and science what we all hope.”
Still, Estep says that more people than you might expect can learn something valuable about their everyday lives through the myGenome test. One example involves the gene HFE, where about 10% of people carry variants linked to the disease hemochromatosis. It’s a mild enough condition to go undiagnosed for decades, but over time, it can cause dangerous amounts of iron to build up in the body. “For people who do carry the HFE mutations, we’ll make clear recommendations that they need to test their iron levels and watch their dietary intake,” Estep says. “And there are other variants that are really common in the population, which are less clinical, maybe, but are also important for overall health and longevity.”
Over time, the Veritas team hopes to offer more and more useful information to every customer, by doing research on its own users―the same way the PGP has identified new genetic health trends among its volunteers. “Sometime next year we’ll hit ten thousand genomes,” says Estep. “And of course we have to link that genomic information to outcomes and medical survey information.” Like 23andMe, Veritas plans to poll its customers about their health and overall lives, and use that data in a feedback loop to make the myGenome reports more comprehensive. Existing customers will get quarterly updates on new results.
That is, if the service survives long enough to get that virtuous cycle rolling. Veritas is expanding aggressively―it has a lab in China preparing to open its doors―but it’s hard to believe it will turn a profit on myGenome any time soon, and FDA intervention will be a constant risk. While many in the field are frustrated with the FDA’s repeated actions against genetic testing, it’s undeniable that services like this will sometimes give customers wrong information. Sequencing is imperfect, and deciding what variants mean is even more so―and however clearly providers explain that a test is only a pre-screen, and the science is unsettled, it’s only human to have a strong reaction to a report on cancer risks in your genome.
Of course, many of these risks are very real, and that’s true whether you choose to look at your genome or not. Estep, who says that future services from Veritas will go further than myGenome and meet clinical standards for diagnosing rare pediatric disease, can attest to this personally. With a family history of Alzheimer’s disease, he has more reason than most to be worried about the information he might find in his genome; nonetheless, Estep was an early customer of 23andMe, and later had his whole genome sequenced for the PGP. (He turned out not to have the highest-risk variants in the key APOE gene.)
“You have what you have, and I think it’s always best to deal factually with what’s in your genome,” he says. “Any serious, clinically relevant variant that we find will basically be front and center. We don’t want it to be missed. We want to notify the person right away that we’re setting up a genetic counseling session.”
CORRECTED 3/29/16: An earlier version of this story referred to the letter Sure Genomics of Utah received from the FDA this February as a "warning letter," and incorrectly stated that the agency asked Sure Genomics to stop selling its whole genome product. The author apologizes for the error. In fact, the letter informed Sure Genomics that the FDA believes the product is a medical device subject to FDA regulation, and asked for more information, but did not order it taken off the market. Sure Genomics is in discussions with the agency.