The Wild West Of China’s Consumer Genetic Testing Industry
If you’ve ever wanted to filter romantic prospects by genetic compatibility, China is the place to be.
“Ask any unmarried, single person when they’re young what [their] standards are [for a boyfriend or girlfriend],” says Wei Zhao (赵伟), the founder of 360°Gene (360°基因, our translation), a consumer genetic testing startup based in Beijing.
“They’re actually very confused,” she says. “They’re not sure. We want to help them solve problems on a genetic level, like those inherent qualities or things about [someone’s] personality that can’t be expressed in a survey.”
360°Gene’s matchmaking application of its genetic testing technology might sound bizarre, but it’s one of many genetic tests in China targeted at the mass consumer market. The country’s direct-to-consumer genetic testing startups assess a dizzying array of traits, from your risk of developing acne to the strength of your short-term memory, and even the likelihood that your child will start smoking as a teenager.
However, clinical applications, such as prenatal and cancer-related tests, are mostly absent. It’s partly because lifestyle applications, such as weight loss, are easier to market to consumers, but also because of the country’s regulations – or lack thereof. Though concrete laws around clinical applications of genetic testing exist, everything outside of that is fair game.
“At the moment, [the China Food And Drug Administration] doesn’t have clear guidelines […] on how to report, how to supervise consumer genetic tests,” says Gang Chen (陈钢), the CTO ofWeGene, a Shenzhen-based consumer genetic testing startup. “I think they’re still in the stages of planning and preparation.”
“The good thing is that you can do pretty much whatever you want – there’s not a lot of limitations,” he says. “But on the flip side, […] if there are rules, you can follow these rules to create products or services. Even if the outcome is bad, at least you were following the rules.”
Shoot First, Aim Later
The field of genetics is not new to China. The Beijing Genomics Institute (BGI), founded in 1999, was one of the key sequencing facilities for the Human Genome Project, which mapped out three billion base pairs of human DNA. Since then, BGI has continued to make headlines, sequencing other flora and fauna such as rice, silkworms, and pandas. China has also conducted some of the most advanced genetic research in the world. In 2015, Chinese researchers were the first to edit genes in a human embryo.
However, the country’s technological advancements are outpacing their laws, especially in non-clinical applications. For example, Chinese companies that want to sell genetic tests directly to consumers do not need a special business license to do so and can sell genetic testing kits without verification or approval from the CFDA. In March 2014, the Chinese government implemented a blanket ban on genetic sequencing in medical applications. A few months later, the ban was lifted.
“In China, laws are always relaxed in the beginning in order to let industries develop,” says Ms. Zhao. “After a period of time, once some issues come up, [the government] tightens them. Then they relax them again. […] It’s a continuous process of opening and closing.”
“It doesn’t matter whether you’re looking at the internet industry or the third party payment industry,” she says. “This is just China’s market environment.”
The legal gray area around genetic testing hasn’t stopped the country’s startups. They’re aggressive when it comes to locking down market share, and price-gouging is common. In the U.S,23andMe, one of the first companies to make genetic tests widely available, sells DNA kits for $149 USD. That’s cheap compared to their competitors, some of which offer more comprehensive tests for around $1000 USD. In China, prices for genetic tests can be as low as 299 RMB or about $49 USD.
“Do I want to sell something to make 9,000 RMB, or do I want to create something that lets as many people as possible know their genetic information?” says Mr. Chen. “In this ecosystem, we want to expand the services. If […] I’m considering the more long-term value of the data, then I should lower the barrier of getting the data in the first place.”
WeGene uses chip-based testing, which is cheaper and faster than other types of genetic tests since they sequence just a few SNPs (single-nucleotide polymorphisms) or hotspots on a gene, as opposed to a panel of genes or an entire genome. The company is also positioning itself as a tech rather than a genetics or healthcare company. It’s even developed an API for its database, hoping to become the data layer between companies that want to create genetics-related applications and consumers.
360°Gene is pursuing a data-driven strategy as well, but instead of offering faster and cheaper tests, they are sequencing entire genomes. Though the company doesn’t need or use all the data for the reports it generates, by holding the keys to their users’ genetic data, 360°Gene can continue to offer users value-added services in the future, such as genome-specific fitness programs.
“It doesn’t matter if you’re sick or not, I can save all your genetic data,” says Ms. Zhao. “That way, when you are sick and […] really need it, I can tell you immediately. This is what really offers value to consumers.”
It’s a smart strategy, but one that gives companies, not consumers, control over their own data. In an unregulated environment where most consumers do not have a basic understanding of genetics, this could mean that users are giving up more than they realize.
Educating consumers is a huge challenge in the consumer genetic testing industry. In other consumer-facing industries, like O2O food delivery or mobile payments, the metrics for quality are straightforward: the food was hot, my money was quickly transferred. But in genetic testing, what counts as high-quality or appropriate testing is much more technical and detailed.
For example, a chip-based test for SNPs associated with breast cancer will not cover all genetic mutations linked to the disease. That means that if your test comes back negative, it doesn’t mean your risk for breast cancer has been properly gauged. Even if your test results do come back positive, it doesn’t mean that you’re going to have breast cancer. However, for some diseases, a chip-based test for SNPs can cover the majority of associated genetic mutations – it just depends.
“It might be that one company does the exact same test, and it just is more expensive and takes longer, and it might be that the company is doing a more complete test, which is why it’s taking longer,” says Dr. Sheila Dobin, a geneticist with a PhD in cytogenetics and medical genetics at Baylor Scott & White Memorial Hospital.
“That’s why […] it’s a good idea to get a genetic counselor [to] look at your family history and say, ‘This is the best test for you at this time,’” she told TechNode.
Most genetic testing startups in China do not offer their users consultation services from genetic specialists. Instead, most settle for a FAQ page or provide a hotline staffed with customer service agents to help users navigate their genetic test reports. It’s not just easier to scale that way – China’s National Health and Family Planning Commission (previously the Ministry of Health) does not offer formal training programs for genetic specialists.
Also, while genetic testing startups will lament the lack of awareness and knowledge among consumers, many continue to produce oversimplified and sometimes misleading marketing material and genetic reports in order to attract more users. For example, some companies market tests for “talent” genes such as athleticism and positive personality traits.
“If […] a child is branded for carrying, say, a ‘gene for ‘puppy love’, ‘prone to violence’, or ‘prone to depression’, it might have a deep psychological impact on the child, and could result in social stigma and genetic discrimination,” wrote authors Suli Sui and Margaret Sleeboom-Faulkner in “Commercial Genetic Testing and its Governance in Chinese Society”, a research paper published in 2015 (paywall).
“Similarly, if a child is regarded as a ‘genius’ on the basis of a genetic test, the high expectations of parents and society regarding gifted children might also put a heavy burden on the child, especially if the child fails to meet the expectations.”
For companies that do offer clinical applications, such as tests for diseases like breast cancer and gout, the ethical quandaries are even more serious. Not only could it result in a consumer taking unnecessary or harmful medical action – especially in the absence of professional genetic counseling – it could put doctors in an ethical bind.
“The big issue here […] is, what if a patient goes directly to a company and gets tested and brings you the test results to interpret?” says Dr. Dobin. “You as a doctor have not ordered that test – do you have to then interpret something you did not order for that patient?”
“Now you have these results you don’t know how to interpret,” she says. “What obligations do you have?”
In many ways, China’s consumer genetic testing industry is simply following the path that most emerging industries take – develop fast and don’t look back. That might work well for some industries, but in an industry like genetic testing, the ethical implications are much more troubling. For now, as China’s consumer genetic testing industry continues to develop without regulation, it’s up to companies to respect and protect their user’s data, navigate the ethics of genetic testing, and offer consumers reliable and accurate tests.
Originally published on TechNode, July 2016