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23andMe Raises $115 Million as It Ramps Up Genetic Testing Internationally

The startup that hit a roadblock with the FDA two years ago is now the leading personal genetics company.

Two years after nearly being shut down by the FDA, genomics startup 23andMe announced on Wednesday it has raised $115 million, funding the company said will contribute to its continued international expansion.

The genomics company, which sells $99 spit tests directly to consumers, expanded earlier this year into medical treatments, partnering with pharmaceutical companies to use its massive DNA database for drug development.

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According to Bloomberg, it also plans to release a health analysis product by the end of this year. The rumored feature is similar to the services 23andMe got a stern warning from the FDA for advertising in 2013 without clearing clinical requirements. The FDA's complaint targeted 23andMe for claiming its tests could provide information on medical conditions like breast cancer, diabetes, and coronary heart disease.

Since then, 23andMe has been working with the FDA to validate these tests, company co-founder and chief executive Anne Wojcicki told Forbes. It was granted approval for a genetic test covering Bloom Syndrome earlier this year. The investment announced this week now puts 23andMe's value at an estimated $1.1 billion, according to Forbes.

23andMe said in a statement the new funding will be used "to expand its operations and maximize the potential of its direct-to-consumer product in the US and abroad." Its growth comes at a time as competition heats up in the personal genetics sphere, with Ancestry.com announcing plans this week to analyze customers' DNA for disease risk.

Wojcicki told Forbes the company is working with the FDA to bring health-related tests to the market soon, and hopes to expand its customer base and DNA database in the process.

"This is a multiyear vision for how we bring genetics en masse to consumers," she said. "This is just step one."