Obviously too much uncertainty to say anything for sure but I don’t see how things can be good for Theranos unless they provide solid, convincing data to allay suspicions raised by WSJ’s reporting. This opinion is based on hazarding the following guesses on how those primarily affected by this story are likely to react.
- Were I a patient, I’d be leery of using their services either right now or in the near future.
- Were I an investor, partner, employee or (CMS), I’d be quite worried about my involvement with or oversight of them.
- Were I FDA/CMS, I’d be thoroughly investigating their practices top to bottom, front to back.
- Were I a competitor, I wouldn’t be worrying about them anytime soon.
Science does not and cannot work on a god-like ‘It works, trust us‘ pronouncement from on above. It works on transparent sharing of process and data with peers. Certain processes are trade secrets? IP (Intellectual Property) protect them with patents. If patents haven’t been approved yet, just describe generalities without details. In any case, process and data are two separate issues. Nothing in the IP realm precludes a clinical blood testing lab’s sharing of data. Why isn’t that happening?
Thing is just sharing test data of hundreds of patients/volunteers on a variety of tests is meaningless without also sharing other pertinent details. For a given blood test done for a Walgreen Theranos Wellness Center patient/volunteer,
- Does Theranos have reference ranges generated on its proprietary in-house developed machines or not?
- Did Theranos generate such reference ranges simultaneously with patient samples on the same machines, i.e., their proprietary in-house developed machines?
- Were patient sample data generated from finger-prick blood samples?
These three questions are key for addressing Theranos’ many public claims about their proprietary technology.
If answers to these questions are yes, and Theranos shares these publicly and soon, that would go a great way in reversing the tide of suspicion currently prevailing against them.
OTOH, for a given blood test,
- If Theranos used commercial machines to generate both patient test numbers and reference ranges, and
- If the majority of these blood samples were arm vein bleeds and not finger pricks, and
- If these are the majority of the data they generated on Walgreen Theranos Wellness Center patients/volunteers,
they just need to admit it. However, if this were the case, it would suggest they were surreptitiously using commercial machines as stop-gap measures while trying to get their proprietary technology up to speed. Problem is this would be contrary to their many public claims. Embarrassing? Yes, but not something worse. Worst case scenario?
- If any of their patient test numbers came off of their proprietary in-house developed machines while any reference ranges or PT (proficiency test) data submitted to either CMS/FDA came off of commercial machines they purchased.
- If test reference ranges and PT data generated on their proprietary in-house developed machines were unreliable and incomparable to those generated on commercial machines, and they hid such data from regulators.
If these two scenarios are true, all hope for regaining credibility is lost.
Sharing their data becomes ever more urgent because there’s nothing but a steady drip-drip of bad news on an almost daily basis. For example, David Crow and Adam Samson of the Financial Times reported on Friday, Oct 23, 2015 (
‘Separate documents show that the full-time director of Theranos’s California laboratory resigned at the end of last year.
He was replaced by Dr Sunil Dhawan, a dermatologist who practices at a clinic in Fremont, California, and who works for Theranos on a parttime basis. He is an experienced practitioner who has run large-scale clinical trials for large pharma companies, such as Allergan, the maker of Botox.
Two people in the industry said that the appointment of a dermatologist on a part-time basis to run a high-profile complex laboratory was unusual. Unlike his predecessor, Dr Dhawan is not certified by the American Board of Pathology, and devotes much of his time to his practice.
Certification by the ABP or a similar body is not a formal prerequisite for laboratory directors, although it is customary for people who run large labs. “Generally, they are certified if they are at a laboratory with an extent of high complexity testing,” said a California state official, who asked not to be named.
A spokesperson for LabCorp, one of the two largest US laboratory testing companies, said that its laboratory directors were “scientists or physicians who have had advanced training in their respective areas and typically have boards or certification granted by the pertinent national organisations” including the ABP…
A Theranos spokesperson said that the company had a full-time, boardcertified lab director who was “waiting for his California licensing to go through.”
One former employee said that the company had struggled to find a new laboratory director when Dr Dhawan’s predecessor resigned in December 2014. The person said that the company had found it difficult to retain staff at the California lab‘.