Two years after FDA letter, 23andMe finally relaunches consumer genetic testing in US

By Aditi Pai
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23andMeAlmost two years after the FDA first told 23andMe to halt sales on its mail-order direct-to-consumer genetic testing service for disease risks, the company has relaunched a version of its new Personal Genome Service (PGS), which now meets FDA standards.

“We’ve worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing," 23andMe CEO Anne Wojcicki said in a statement. "We are a better company with a better product as a result of our work with the FDA. This is an incredibly dynamic time in genetics and we’re excited to be at the leading edge of bringing genetics directly to individuals as they begin to learn about their 23 pairs of chromosomes.”

23andMe's offering, which first launched in 2007, sends users a saliva collection kit. After spitting in the tube provided and mailing it back to the company's lab, 23andMe emails the user within about two months that their reports are ready and available to review in an online portal. The price of the original offering six years ago first started around $399, but over time was decreased to $99. The new offering that was just launched costs $199. The new Personal Genome Service provides users with more insights than the company offered before, according to the company.

One type of 23andMe report, the carrier status test, provides users with data on 36 inherited conditions, including cystic fibrosis and sickle cell anemia. Another report users will get helps them understand how their DNA relates to their caffeine consumption, lactose digestion, and muscle type.

During the two years that 23andMe was working with the FDA to develop this new offering, the company was still active both in the US and in other countries. Here's a summary of what 23andMe has been up to since the FDA letter first came out.

November 22, 2013: The FDA instructed 23andMe to immediately stop selling its testing service until the offering receives de novo 510(k) clearance.

“[M]onths after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS [personal genome service],” Alberto Gutierrez, director of in vitro diagnostics and radiological health wrote in the letter, adding that FDA interactions with 23andMe had included “more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications.” 

Early 2014: 23andMe announced three new hires. First, in April, the company hired Kathy Hibbs as Chief Legal and Regulatory Officer. Hibbs previously held positions at Monogram Biosciences and Varian Medical Systems. A week later, 23andMe hired Dr. Jill Hagenkord as the company's chief medical officer. And in June, the company added Angela Wonson as vice president of communications. She previously worked at  Intuitive Surgical, which develops robotic-assisted surgical systems.

July 2014: The company received a $1.4 million grant from the National Institutes of Health. 23andMe will use the funds to improve its web-based surveys, add more survey tools that will help the team collect a broader set of phenotypic data, and create a tool that allows researchers who are not affiliated with 23andMe to access aggregate deidentified data from the 23andMe database. A spokesperson told Reuters at the time that the announcement does not suggest 23andMe is going a new direction -- she explained the company has used data for research in the past as well.

August 2014: 23andMe announced a partnership with Pfizer. The companies said they would work together to enroll 10,000 people with inflammatory bowel disease (IBD) in a study designed to study the genetic factors associated with the onset, progression, severity, and response to treatments for IBD. One of the four advisors for the project is Larry Smarr, founding director of the California Institute for Telecommunications and Information Technology (Calit2), who was previously diagnosed with Crohn’s disease.

December 2014: 23andMe finally relaunched its mail-order personal genetic testing service — just not in the United States. Instead, the company offered it in England, which has a different regulatory framework than the United States. 23andMe said it would only ship to a UK IP address and a UK shipping address. And although the MHRA did not require premarket approval like the FDA, the organization said it was keeping an eye on 23andMe.

January 2015:  23andMe announced another partnership with Pfizer. As part of the deal, Pfizer receives access to 23andMe’s Research Portal, which includes anonymous, aggregate data from 80 percent 23andMe’s genotyped population of over 800,000 individuals. This portion of the population consented to participate in research. The two companies also said they would launch a longitudinal study of 5,000 people with lupus. According to Bloomberg, the company said it would announce 10 more deals similar to this one in 2015.

March 2015: The company created a therapeutics group led by former Genentech executive Richard Scheller. The group was created to use 23andMe’s database of consented, re-contactable subjects with sequenced genomes to develop new drugs.

June 2015: 23andMe genotyped its one millionth customer.

July 2015: According to an SEC filing, 23andMe raised $79 million. The filing stated that the company aimed to raise $150 million.

October 2015: 23andMe raised another $36 million, closing its round at $115 million. The round was led by Fidelity Management and Research Company with participation from Casdin Capital, WuXi Healthcare Ventures, and Xfund, as well as existing investors Illumina, New Enterprise Associates, MPM Capital, and Google Ventures. 23andMe has raised a total of $241 million to date, a spokesperson from the company told MobiHealthNews at the time.

This week, BuzzFeed pointed out, 23andMe released a transparency report that disclosed the number of law enforcement agency requests they have received. The report shows that they have received four user data requests that ask for information on a total of five 23andMe users, but 23andMe has never complied with a request.

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