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New Laboratory Testing Firm Seeks to Shatter Old Testing Model

A Palo Alto company could be poised to potentially change the existing laboratory testing model for consumers, the San Francisco Business Times reports. 

Theranos has been offering tests based on a pin prick's worth of blood in Walgreens in the Phoenix area and one in Palo Alto, California for routine analysis such as blood cholesterol levels and diabetes, without a physician's order. 

Now, the company has added a full blown reference laboratory, which means it would be able to offer genetic tests, specialty tests, and esoteric tests and to capture a greater share of the testing market. 

"We don't want (consumers) to come to us for some tests and others'" for other tests, Theranos CEO Elizabeth Holmes tells SFBT. Theranos would offer its tests at lower costs than traditional labs such as Quest Diagnostics and Laboratory Corporation of America. 

Additionally, the company has hired Heather King, a former policy adviser to Hillary Clinton, as its general counsel to manage Theranos' regulatory affairs and intellectual property, Bloomberg Business reports. 

King had already been advising the firm on an Arizona law allowing patients to order bloodwork without a physician order. In her new position, she will push for similar changes in other states, though she declined to say where. 

Holmes tells the publication that the idea behind Theranos is to "let individuals take chare of their own health through preventative testing." 

""It's a basic human right for people to get access to information,'" she told Bloomberg Business, and the company lists the prices for its test on its website.

Theranos reportedly has added BRCA1 mutation testing to its menu, though it is not listed on its online menu. It is unclear whether the company plans to offer such tests without the need for a doctor's prescription, but in light of the US Food and Drug Administration's crackdown on 23andMe in late 2013 — the agency asked 23andMe to discontinue marketing health-related genetic test results directly to customers through its Personal Genome Service — it is unclear how Theranos could offer such tests and still avoid regulatory scrutiny. 

Holmes tells Bloomberg Business "We want people to have end-to-end service, so over the last few months we've been quietly adding tests that historically have been the most expensive and making them available at 50 percent of the Medicare reimbursement rate, or even a 90 percent discount."