Theranos gets nod from FDA for possible in-home testing
SAN FRANCISCO - Although Theranos has operated largely in stealth mode since founder Elizabeth Holmes started the blood-testing biotech venture more than a decade ago, recent government approvals have shed light on the company's roadmap.
A few weeks ago, the Food and Drug Administration granted approval to Theranos' innovative finger-prick method, which requires mere drops of blood as opposed to vials to run complex tests. The agency also specifically gave its blessing to Theranos' test for the herpes simplex 1 virus.
But on Thursday, the FDA gave Holmes yet another thumbs up that could radically expand the company's business potential. By granting Theranos the right to conduct that herpes test outside of a lab - a so-called CLIA waiver - the FDA is giving the Palo Alto-based startup the green light to offer consumers even greater flexibility and itself a broader revenue stream.
Possible implications of a CLIA-waver would be creating a test that could be taken at home, akin to a pregnancy test, while another would be to allow patients to get immediate test results at Theranos' growing network of Wellness Centers without having to export the blood work to one of its labs.
Theranos currently has centers in 42 Walgreens stores in Arizona, one near its Silicon Valley headquarters and a newly opened facility at a Capital Blue Store in Harrisburg, Pa. Holmes' long stated goal is to have a Theranos center within five miles of every American, which stems from her belief that monitoring one's health via frequent and inexpensive blood tests can lead to early disease detection.
Theranos has raised nearly half a billion dollars in venture capital funding to date, and is currently valued at $9 billion. Holmes owns half the company.
The company's other big coup of late was the July 3 enactment of a new Arizona law that allows residents of that state to order blood tests without a doctor's note. The law also protects physicians from lawsuits as it places the onus of interpreting any results on the consumer.
“Receiving this CLIA Waiver is an important milestone in fulfilling Theranos’ mission to provide actionable information at the time it matters,” the founder said in a statement announcing the latest FDA approval. “Having the ability to make our test and system more broadly available in a variety of settings is critical to our aspirations to contribute to public health, as we continually innovate to provide the best laboratory testing services in the world.”
The latest FDA coup may focus on the possibility of taking a herpes test at home, but "its implications are far broader than that," says Eric Lakin, analyst with DeciBio Consulting.
"Theranos was busy building a hub and spoke model, with its Wellness Centers in Walgreens stores being the spokes, and their (regional) labs being the hub," says Lakin. "But now this raises the possibility that a consumer could have a test run immediately at that Walgreens, which is not a CLIA-approved facility. The other possibility of course is having a test that wouldn't even require that Walgreens. The most disruptive part of all this is that testing could be done in people's homes."
Lakin says that the recent news about Theranos and its various government approvals goes a long way to assuaging some company critics, who have expressed concern about the intense secrecy surrounding its plans. But it won't make everyone a true believer just yet.
"The FDA is the gold standard when it comes to approving testing, but the scientific community will still be asking to understand how Theranos does what it does in a bit more depth," he says.
Follow USA TODAY tech reporter Marco della Cava on Twitter: @marcodellacava