Did Theranos Turn Over its CLIA Lab Director?

Did Theranos Turn Over its CLIA Lab Director?

PROBABLY NO SINGLE LAB INDUSTRY STORY OF THE PAST 24 MONTHS has generated a higher level of curiosity among pathologists and lab administrators than that of Theranos, the Palo Alto, California-based company that regularly claims it has the technology, the business model, and the low price strategy needed to disrupt the clinical lab testing marketplace.

Not surprisingly, within the profession of laboratory medicine, there are many pathologists and laboratory scientists who want to know more about the company’s proprietary diagnostic technology. Because the clinical lab profession is such a small community, these “Theranos watchers” are sharing information about the lab company at meetings and on lab bulletin boards.

This information is a pastiche of known facts, leavened with speculation that may or may not be informed. One factor working against Theranos’ desire to control all information about the company is the close-knit scientific community of pathologists. Everyone knows everyone, so to speak. It is these personal relationships that are the source of a rumor about how, in the past month, the pathologist who was the medical director on the Theranos CLIA certificate (believed to be the Palo Alto lab facility) has left the employ of Theranos. Individuals claiming to know about this situation said that, after leaving Theranos, this individual did not go directly to a new position.

Given the nature of pathologists to have well-organized lives, including not leaving one job without having a new job ready, the pathologists who are aware of this transition have an interesting hypothesis. They point out that, if Theranos asked this CLIA medical director to approve policies or lab testing practices that this pathologist believed to not be in accordance with federal and state regulations, this could be a reason why the company and the pathologist decided to terminate the relationship.

Because of non-disclosure agreements that Theranos vigorously enforces, if this pathologist’s medical directorship did end, the truth of the matter is not likely to be known. But should elements of this rumor be true, then one speculation is that the termination might point to possible tension between the business objectives of Therano’s owners and how the pathologist-medical director wanted to operate the clinical lab in conformance with federal and state laws. Whether the rumor is accurate or not, one thing is true: neither party is talking!

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