consultant for the innovation team, didn’t take part in the meeting.
But when he heard that several Walgreens executives had had their
blood tested, he figured this was an opportunity to finally see how the
technology performed. He told himself to follow up with Elizabeth
about the test results next time they talked. In a report he’d put
together after the Palo Alto visit, Hunter had warned that Theranos
might be “overselling or overstating...where they are at scientifically
with the cartridges/devices.” He’d also recommended that Walgreens
embed someone at Theranos through the pilot’s launch and had
volunteered one of his Colaborate colleagues, a petite British woman
by the name of June Smart who’d recently completed a stint
administering Stanford’s labs, for the assignment. Theranos had
rejected the idea.
Hunter asked about the blood-test results a few days later on the
weekly video conference call the companies were using as their
primary mode of communication. Elizabeth responded that Theranos
could only release the results to a doctor. Dr. J, who was dialed in from
Conshohocken, reminded everyone that he was a trained physician, so
why didn’t Theranos go ahead and send him the results? They agreed
that Sunny would follow up separately with him.
A month passed and still no results.
Hunter’s patience was wearing thin. During that week’s call, the two
sides discussed a sudden change Theranos had made to its regulatory
strategy. It had initially represented that its blood tests would qualify
as “waived” under the Clinical Laboratory Improvement Amendments,
the 1988 federal law that governed laboratories. CLIA-waived tests
usually involved simple laboratory procedures that the Food and Drug
Administration had cleared for home use.
Now, Theranos was changing its tune and saying the tests it would
be offering in Walgreens stores were “laboratory-developed tests.” It
was a big difference: laboratory-developed tests lay in a gray zone
between the FDA and another federal health regulator, the Centers for
Medicare and Medicaid Services. CMS, as the latter agency was
known, exercised oversight of clinical laboratories under CLIA, while
the FDA regulated the diagnostic equipment that laboratories bought