• Startup unveils latest kit after FDA halted sales in 2013
  • Revamped screening service covers 36 genetic disorders

Genetic testing company 23andMe Inc. has restored some health analysis to its latest DNA screening kit, ending a two-year hiatus after a standoff with U.S. regulators.

The Silicon Valley firm, which recently raised $115 million in venture-capital funding at a valuation of $1.1 billion, introduced its redesigned personal genome service on Wednesday. The kit brings together ancestry analysis with reports on physical traits such as baldness or freckles, health conditions such as lactose intolerance and whether the consumer carries genetic mutations associated with certain disorders. The service costs $199, double the previous $99 price tag.

The startup had hit a roadblock in late 2013 when the U.S. Food and Drug Administration stopped it from selling reports with health analysis to consumers without regulatory clearance. Sales took a hit, and it took more than a year for Mountain View, California-based 23andMe to work its way back into the agency’s good graces.

“We are the first company that has gone through the FDA and has a genetic test that is authorized by the FDA to go direct to consumers,” Chief Executive Officer Anne Wojcicki said in a telephone interview.

“I think it’s really clear to us now how much we did not know” before going through the FDA process, she said. “I look back and I’m really happy we went through those two years. We’re a better product now.”

Mail-In Test

Customers receive a collection kit in the mail including a tube for a spit sample. After mailing the sample back to 23andMe’s lab, the company returns an online report in six to eight weeks, according to spokeswoman Angela Calman-Wonson.

In February, the FDA cleared 23andMe’s test for Bloom syndrome, a disorder associated with short stature, sun sensitivity and higher cancer risk. More importantly, the FDA also said further tests for autosomal recessive disorders would be exempt from premarket review.

Autosomal recessive disorders are genetic conditions in which two abnormal genes must be present for the disease to manifest, one from each parent. 23andMe’s new test covers 36 such disorders, including cystic fibrosis and sickle cell anemia. Many other genetic variants that 23andMe previously reported, including risk factors such as the APOE4 gene, aren’t included in the new test so far. When mutated, APOE4 gives the carrier a higher -- but not definite -- chance of developing Alzheimer’s disease.

Genetic Disorders

Wojcicki says 23andMe is working with the FDA to bring back those reports. 

“I think this is a really small slice of what’s eventually going to come,” she said. Consumers who buy the test now will be able to get updated reports at no additional charge as more genetic variants are added to the product, she said.

The revamped test also will feed data into 23andMe’s new drug-discovery unit, led by Genentech Inc. veteran Richard Scheller. Along with gathering genetic information, 23andMe also surveys its customers on their physical traits and symptoms. By developing this unique database, the company hopes to gain a better understanding of how genes drive disease, leading to new drug targets. Out of 1 million customers, more than 80 percent have consented to participate in research, 23andMe has said.

Data Security

The company stores genetic information separately from personal information, such as names and birth dates, said Kate Black, 23andMe’s privacy officer and corporate counsel. The only time the two sets of data are brought together is when an individual logs into the site to view his or her report, she said. Security at 23andMe is “above and beyond the industry standard,” she said.

Consumer adoption of genetic services is still low, according to venture firm Rock Health. In a survey of 4,000 consumers, only 7 percent had used a genetic service, and more than two-thirds of non-adopters said they currently had no plans to use one, a finding that suggests “mainstream use cases beyond genealogy are still yet to be discovered,” Managing Director Malay Gandhi wrote in Rock Health’s 2015 Digital Health Consumer Adoption report.

So far, 23andMe’s customer base is “very engaged with health,” Wojcicki acknowledged, so the firm is focusing its efforts on educating consumers and physicians alike to expand the market.

Still, she sees a “consumer revolution” in the works. “People want to be in charge of health information. They want it available the same way online banking is available,” she said.

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