The fundamental building blocks of human life can be read in the 3-billion letters of a person’s genome. Starting next month, a startup called Veritas Genetics will reveal your unique code for only $999. You can browse the results in a smartphone app.
Since 2003, when the first full human genome was sequenced (at a cost of $3 billion), geneticists have been dreaming of the “$1,000 genome.” It is the price that many think will usher in an era of predictive and personalized medicine.
But the $999 offer comes amid confusion about what such genomic data can and cannot do. For instance, genetic data might be able to tell you that you are at a higher risk of getting, say, breast cancer. Whether you should then get a double mastectomy—as Angelina Jolie did when she found out she was a carrier of the BRCA1 gene—remains a tough question to answer.
The BRCA1 test is as good as things get in health advice that stems from simply looking at genes—most other tests provide less conclusive insights. “Stepping on your weight scale is more predictive of future health issues than almost all the information you’ll get from a genome scan,” Timothy Caulfield, a researcher at University of Alberta, told Stat.
Most companies selling similar products to Veritas Genetics seem to make promises that aren’t true, and the regulatory authorities are taking note. In 2013, the US Food and Drug Authority (FDA) ordered 23andMe to stop providing medical advice on health conditions based on its genetic tests, which only look at certain parts of a genome for $199. After two years of regulatory limbo, 23andMe is back on the market, offering advice. But instead of estimating risks for 240 health conditions like it did before, it offers “carrier status reports” for some 36 conditions.
Veritas Genetics will have to play by the FDA’s rules too. To fall under looser regulations, it requires a doctor’s approval before users can get their full genome sequenced. This way, Veritas Genetics won’t be selling under stricter “direct-to-consumer” rules, as 23andMe does.
Can Veritas Genetics make money by offering such a low price for its test? Most current tests for full-genome sequencing cost more than $6,000. Last month, Sure Genomics announced a major advance that allowed it to charge $2,500.
In a sense, these biotech startups are using similar tactics to tech firms—get users first and worry about business models and regulatory details later. To boost its bottom line, Veritas Genetics is offering add-on services, such as counseling to interpret the app’s results, on top of the $999 sticker price.
Optimism in the industry is high, but the clinical benefits and financial sustainability of its products are up for debate.