[DIYbio] Re: "Theranos, CEO Holmes, and Former President Balwani Charged With Massive Fraud"




http://sdbj.com/news/2019/dec/03/truvian-seeks-decentralize-lab-test/

Oh no lets hope the FDA watches over this company called Truvian and hope this is not a snake oil operation. 


Truvian Sciences wants to run a battery of tests on only drops of blood. Its mobile lab is designed to return answers in 20 minutes. Sound a little familiar?

Truvian's mission of disrupting lab testing harkens to Theranos, the now-dissolved Silicon Valley firm that's infamous for faulty blood tests. Truvian CEO Jeff Hawkins knew the question was coming: What makes Truvian different?

Unlike Theranos, he said Truvian is seeking regulatory approval, and it's led and advised by a pack of life sciences talent — among other differences.

"We've surrounded ourselves with investors from the health care space, but also independent scientific and clinical advisers," Hawkins said.

In a vote of confidence, Truvian recently raised $27.1 million in a Series B round. With that, the company will accelerate the development of its benchtop system. By the end of 2020, Truvian plans to ask for approval from the U.S. Food and Drug Administration, followed by European Union regulators.

But as Truvian distances itself from the Theranos tag it faces competition, including in its backyard in San Diego.

Founded in 2015, Truvian wants to make blood tests a routine exercise at retailers and clinics. Its machine is designed to return results in only 20 minutes, rather than shipping samples to industry behemoths Quest Diagnostics and Lab Corp — and waiting days.

The idea is that patients could order a test and shortly thereafter consult a doctor, sparing another appointment. Rapid tests would also mean less physician guesswork, which can spawn unnecessary or even harmful treatment.

Common Diagnostic Tests

Plans call for Truvian's device to cover 40 of the most commonly ordered diagnostic tests, such as those assessing thyroid, liver and kidney function. Patients could access results via a mobile app.

Hawkins said with so many tests on one system, both clinics and individuals would save money.

In one sense, he said, Theranos cast a pall over the industry, but in another the company got more thinking about shaking up the blood testing industry. But Truvian — which has raised $47.3 million to date — isn't the only firm vying to do so.

"There's a few companies making themselves out to be the anti-Theranos," said Bruce Carlson, publisher of market research firm Kalorama Information.

Locally, Genalyte is developing a system to run 100 common lab tests within 15 minutes. The company is also working toward FDA approval, and it already has a nonproprietary version on the market.

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