It is now the only company cleared to offer genetic health risk reports direct-to-consumer.

By Clifton Leaf and Sy Mukherjee
April 6, 2017

Hello, readers—this is Sy.

23andMe just pulled off a milestone feat: On Thursday, the Food and Drug Administration (FDA) said the company could sell its genetic tests and accompanying health risk reports for ten different diseases directly to consumers. That means that, for the first time ever, Americans won’t have to get a prescription to receive detailed medical reports about their chances of developing diseases like Alzheimer’s, Parkinson’s disease, celiac disease, and other disorders based on analyses of their genetic makeup.

“The FDA has embraced innovation and has empowered people by authorizing direct access to this information,” said 23andMe co-founder and CEO Anne Wojcicki in a statement. “It is a significant step forward for 23andMe and for the adoption of personal genetics.”

This moment has been a long time coming for the company, which is now the first and only one in the U.S. that can provide such health reports to consumers without a prescription. In late 2013, the FDA sent Wojcicki a warning letter stating that the firm’s Saliva Collection Kit and Personal Genome Service (PGS) was being marketed to consumers without proper regulatory clearance. The PGS platform promised genetic risk reports for more than 250 disease at the time—but, after the FDA smackdown, 23andMe was forced to stop marketing the service and pursue a piecemeal strategy of winning regulatory approval of individual tests. In February 2015, the FDA authorized its direct-to-consumer test for the rare disorder Bloom syndrome.

But Thursday’s approval is far more significant because it allows 23andMe to, not just provide DTC genetic testing for a range of diseases, but also send customers reports about their genetic risks “which may help [them] to make decisions about lifestyle choices or to inform discussions with a health care professional,” according to the FDA.

To get to this point, 23andMe had to conduct extensive studies proving the accuracy of its tests and assuring regulators that the reports can be easily understood by consumers so that they can make informed health care decisions.

Still, the FDA offered up a word of warning over the newly available tests.

“[I]t is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease,” said Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health.

Read on for the day’s news.

Sy Mukherjee
@the_sy_guy
sayak.mukherjee@fortune.com

DIGITAL HEALTH

AI and CRISPR gene-editing are helping us better understand stem cells. A combination of CRISPR and machine learning has helped produce a new public database containing thousands of 3D images of stem cells—and researchers hope that it can be used to improve drug development, cancer detection, and general understanding of stem cells by providing a glimpse into their different molecular structures. The Allen Cell Explorer was created by Seattle’s Allen Institute for Cell Science and already contains more than 6,000 images. The images highlight where genes are located and cells are comprised. How did researchers pull off this feat? By using CRISPR-Cas9 to insert certain genetic tags into stem cells which glow. Then, when they saw that even cells that were clones of a single parent cell can have wildly differing structures, they used machine learning so that a computer could begin predicting stem cell structures with a limited amount of information. (Nature)

Theranos founder Elizabeth Holmes reportedly owes her company $25 million. The hobbled blood testing unicorn Theranos is reportedly employing an interesting tactic to convince investors not to sue the company: telling investors and founder Elizabeth Holmes will pay them with part of her personal shares of the private company. She reportedly owes the firm $25 million under a deal she struck with Theranos. (Fortune)


INDICATIONS

Allergan really, really wants to make Botox a depression treatment. Allergan’s flagship wrinkle-fighting injectable treatment Botox is already cleared to treat a number of conditions that you might not associate with it, including chronic migraines and sweaty underarms. But the company is going forward with plans to test it out in a late-stage trial for major depression in women. Allergan announced on Wednesday that it’s moving into phase 3 studies even though mid-stage trials were a mixed bag. The therapy failed to best placebo at a high dosage and didn’t improve upon placebo to be considered statistically significant in other when it came to treating depression symptoms. Still, the drug giant believes a more pronounced advantage over placebo will become evident in a larger study. (Fortune)

How does the FDA fare against its European counterpart on drug approvals? Drug approvals are a hot topic these days as confirmation hearings for Donald Trump’s FDA chief nominee, Dr. Scott Gottlieb, are underway. Some of the president’s rhetoric about the agency invokes a picture of an FDA that needlessly holds up life-saving and innovative drugs with bureaucratic red tape. But a new paper published in the New England Journal of Medicine at least partially contradicts those claims, highlighting that the FDA is actually better about approving drugs than its counterpart in Europe, the European Medicines Agency (EMA). “The FDA approved 170 new therapeutic agents between 2011 and 2015, and the EMA approved 144,” wrote the study authors. What’s more, the regulatory review process for new drugs was a full two months shorter at the FDA than at the EMA—but those advantages were mostly concentrated on cancer and blood disease drugs and treatments for rare diseases. (NEJM)


THE BIG PICTURE

Big pharma companies are ditching Bill O’Reilly’s show. Fox News’ Bill O’Reilly is currently facing a mass exodus of advertising partners for his popular show The O’Reilly Factor in the wake of numerous sexual harassment allegations. In fact, 56 companies have now announced that they’re pulling ads from the show—including several big name drug makers: Sanofi, Eli Lilly, Bayer, GlaxoSmithKline, and Bristol-Myers Squibb. (Axios)

Zika virus birth defects are on the rise in the U.S. A new Centers for Disease Control (CDC) report finds that one in 10 pregnant American women who had laboratory-confirmed evidence of Zika virus infection had babies or fetuses with birth defects. Out of nearly 1,000 completed pregnancies marred by Zika infection, 51 fetuses or infants had the defects associated with the virus, including 43 with microcephaly—abnormally small heads—or problems with the brain and central nervous system. Other defects included eye problems, central nervous system issues, and neural tube defects. (Fortune)


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