Recently, we’ve been receiving inquiries from some of our IVD clients about the latest developments with Theranos, Inc. They want to know if Theranos’ troubles indicate a shift in FDA policy toward regulation of IVDs or whether it is merely another indication of FDA enforcement action against CLIA laboratories offering LDTs. The answer to the first question is “No”, but the answer to the second is “Definitely yes”.
For background, Theranos, Inc. is a Silicon Valley “teenage startup” that offers laboratory-developed tests (“LDTs”) through its CLIA-licensed laboratory in Palo Alto, CA. Currently, FDA is exercising enforcement discretion over such tests while it digests public comment on a controversial draft guidance that will implement a risk-based approach to regulation of LDTs. Theranos claims to have a technology that will “reinvent the lab test” and deliver actionable test results for more than 150 standard clinical blood tests in 10 to 15 minutes at a cost of less than $10 – heady stuff that, if it works, would stand the competitors Quest Diagnostics and LabCorp on their collective heads. The company was hyped in the media and according to the Wall Street Journal, it is valued at $9 billion on the basis of – well, not much apparently.
On October 16, 2015, the Wall Street Journal (WSJ) published an article about Theranos that called into question the veracity of the company’s public statements regarding its IVD technology and throwing a spotlight on the company’s CEO. The article, and a subsequent WSJ report of FDA inspections of Theranos, set the social media buzzing with volumes of commentary across the spectrum of opinion. This was followed by a press release from Theranos rebutting the contents of the WSJ articles. Then on October 27, the Office of Regulatory Affairs in FDA released redacted versions of the forms FDA 483 Inspectional Observations from inspections conducted during August and September. These documented systemic violations of the Code of Federal Regulations (CFR) regarding establishment registration and listing and the Quality System Regulation (QSR).
Notably, Theranos appears to have begun its relationship with FDA on the right path. The company is on record that it agrees with FDA oversight of LDTs and that it is in the process of submitting to FDA premarket applications for all of its tests.
The company properly registered and listed its devices with the FDA.
And, Theranos has achieved clearance for one of its tests.
So, what happened? Where did Theranos go wrong?
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.