controversial among its members. Some had argued forcefully that it
should be withdrawn given the events of recent months. But the
association’s leadership had seen a chance to generate publicity and
buzz for the normally staid scientific conference. It was proven right in
that regard: several dozen journalists had made the trek to
Philadelphia to watch the spectacle.
After a few introductory remarks from AACC president Patricia
Jones, Holmes stepped up to the lectern. She wore a white blouse
under a dark jacket. Gone was the black turtleneck, which had become
an object of ridicule since the previous fall.
What followed wasn’t so much a scientific presentation as it was a
new product exhibit. Over the next hour, Holmes proceeded to unveil
the machine that had been but a malfunctioning prototype when
Theranos had gone live with its blood tests nearly three years earlier:
the miniLab. Theranos’s engineers and chemists had improved the
device since that early model, but the company still hadn’t conducted a
full clinical study to prove that it worked reliably across a wide range
of assays using blood pricked from fingertips. While Holmes’s
presentation included some data, much of it involved venous blood
drawn from the arm. The little finger-stick data it contained covered
only eleven blood tests and wasn’t independently verified or peer-
reviewed. CMS had just banned Holmes from running clinical
laboratories, but no matter: she explained that the miniLab connected
wirelessly to servers at Theranos headquarters and could be deployed
directly in patients’ homes, doctors’ offices, or hospitals, doing away
with the need for a central lab.
In effect, she was pirouetting back to her original vision of portable
blood-testing machines operated remotely through Wi-Fi or cellular
networks. Of course, after everything that had happened,
commercializing such a system without the FDA’s approval was out of
the question. And putting together the thorough studies the agency
would want to see would take years. That was why she had tried to
bypass the FDA in the first place.
The odds that Holmes could pull off this latest Houdini act while
under criminal investigation were very long, but watching her