Startups, Diagnostics

Theranos gets first FDA clearance, emerges from secrecy

Theranos, the secretive Palo Alto diagnostics company, just received regulatory approval for its HSV-1 test – a sign that perhaps it’ll start chasing further approvals.

The veil is lifting: Theranos just received its very first FDA clearance today.

The secretive Palo Alto diagnostics company just received regulatory approval for its test for herpes simplex 1 virus IgG – a sign that it’ll start chasing further approvals.

Theranos has committed to submit all of their diagnostics for FDA review, with well over 100 pre-submissions underway, a representative for the company said in an email to MedCity News.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

The approval is certainly validation that Theranos’ science, which has come into question, does meet with the FDA’s rigorous standards. And unlike therapeutics, FDA approval for diagnostics is not mandatory – meaning this step is a move toward transparency that Theranos has otherwise been criticized for lacking.

Theranos says it handed over to the Agency data on its test systems, methods, chemistry, hardware and software. It gave data from 818 subjects of different ages and ethnicities – showing the system could work just as well with a finger stick as it does with a traditional venous blood draw.

It compared the efficacy across 69 Theranos devices, to try and offset any variance between devices. It tested venous serum, venous plasma, capillary plasma and capillary whole blood to demonstrate the similarity in efficacy of its HSV-1 test.

The company was founded in 2003 by CEO Elizabeth Holmes, a Stanford dropout, with aims to democratize and lower the costs of blood-based diagnostics. Its HSV-1 test costs $9.07 – one of 153 tests the company says it makes that cost less than $10.

The company has been ramping up its publicity efforts of late, perhaps indicative that it’s soon going to spread beyond having Walgreens-based clinics in only Arizona and California. For instance, it just announced it’s created a web portal to help patients and primary care doctors interface over diagnostic results.

Since its launch 12 years ago, Theranos has gained a $9 billion valuation – and a reputation for holding its science too close to the chest. However:

“Theranos is deeply committed to transparency in the laboratory testing space,” the company said in the statement.

Bravo.