The first inkling for me that a new trend was afoot was a blog note about Theranos by Jean-Louis Gassée (see: Theranos Trouble: A First Person Account). Here is an excerpt from his note:
...[I] stroll to Stanford Hospital’s Hematology Lab to give blood samples that are tested for Complete Blood Count (CBC) and Metabolites....On my way back to my University Avenue office, a thought pops up: Why not try Theranos for comparison?....A few minutes later, I’m in the small Theranos office inside the University Avenue Walgreens store,....I gain access to my [Theranos] numbers:— Platelets: 430...— Hematocrit: 44.1, a passing grade, but uncomfortably close to the 45% limit. Stanford Hematology disagrees:— Platelets: 320,...— Hematocrit: 41.1, ditto.
[Theranos: platelets 430,000; hematocrit 44.1. Stanford: platelets 320,000; hematocrit 41.1. Same day]
Here's a report from another "secret lab shopper" (see: Crowdsourcing a Theranos test?):
On June 29th I went to the Hematology lab at Stanford for routine CBC and Metabolites numbers. As I walked back to Palo Alto, I stopped by my doctor’s office, got an order, went to the Theranos office at Walgreens on University Avenue in Palo Alto and got a CBC test. Taken one hour apart, the Stanford and Theranos HCT numbers differ by about 7%: 44.1 Theranos vs. Stanford 41.1. For platelets, the difference is even wider: Theranos 430 vs. Stanford 320. Intrigued, I got a new order and went back to Theranos the following day, on June 30th. Theranos numbers were markedly different 24 hours later: HCT 40.6; PLT 375. Just to make sure, I went back to Stanford for a second test today July 1st: Stanford HCT 41.7; PLT 297,
[Theranos: platelets 430,000; hematocrit 44.1. Stanford: platelets 320,000 hematocrit 41.1; June 29]
[Theranos: platelets 375,000; hematocrit 40.6; June 30]
[Stanford: platelets 297,000; hematocrit 41.7; July 1]
This is the first time to my knowledge that "mystery shoppers" have compared lab test data from two separate labs and published the data on the web. Much of the content of most lab reports is, of course, quantitative so they lend themselves to such comparisons. Obviously, these are small samples and caution needs to be exercised in their interpretation. It's of note that the Stanford results in the second report shows the precision (i.e., repeatability) that I might expect (see: How Reliable is Laboratory Testing?).
Germane to this, it's of interest that the Theranos reference lab in Newark, California, the lab I assume was running the Theranos tests referred to above, is searching for a new lab director. Here some information about the current medical director (see: Theranos Searches for Director to Oversee Laboratory):
Diagnostics startup Theranos Inc. is seeking to hire a laboratory director to oversee one of its key facilities amid questions raised in laboratory circles about the qualifications of a physician who now runs the lab. The blood-testing company has been operating its Newark, Calif., lab for the past 10 months under the supervision of Sunil Dhawan, a dermatologist without a degree or board certification in pathology or laboratory science....Theranos says its lab work is accurate and the concerns unfounded. Dr. Dhawan, 56 years old, meets federal and state requirements to be a lab director because he is a medical doctor and has experience overseeing a lab. Theranos said he has supervised the lab affiliated with his dermatology practice for over 21 years.
In my experience, it would be almost inconceivable for a part-time dermatologist with experience in dematopathology rather than a clinical lab scientist with a Ph.D. or fully trained pathologist, to head up a large clinical pathology reference lab, particularly for a multi-billion dollar enterprise like Theranos.