were poor and wouldn’t pass muster, he added. When in turn I told
him about the things I had learned in the course of my reporting,
ranging from Theranos’s practice of running diluted finger-stick
samples on commercial analyzers to its gaming of proficiency testing
and the questionable test results some doctors and patients had
received, he sounded disturbed.
Part of the problem was that, three years after Holmes’s clash with
the now-retired Lieutenant Colonel David Shoemaker, Theranos
continued to operate in a regulatory no-man’s-land. By using its
proprietary devices only within the walls of its own laboratory and not
seeking to commercialize them, it was able to continue to avoid close
FDA scrutiny. At the same time, it gave the appearance of cooperating
with the agency by publicly supporting its drive to regulate laboratory-
developed tests and voluntarily submitting some of its own LDTs, like
the herpes test, to it for approval.
My source said it was hard for the agency to take any adverse action
against a company that portrayed itself as the lab world’s biggest
advocate of FDA regulation, especially one as politically connected as
Theranos. At first, I thought he was referring to its board of directors,
but that was the least of his concerns. He pointed out how chummy
Holmes had gotten with the Obama administration. He had seen her
at the launch of the president’s precision medicine initiative earlier in
the year, one of several White House appearances she’d made in recent
months. The latest had been a state dinner in honor of Japan’s prime
minister, where she was photographed in a body-hugging black gown
on the arm of her brother. Despite all this, his parting words made me
think Theranos might not be able to fool the FDA much longer: “I’m
very concerned about what they’re doing.”
—
OVER AT FORTUNE, Roger Parloff had a different take on the herpes
test approval than I did. In an article he published on the magazine’s
website, he wrote that it was “a strong endorsement of the integrity of”
Theranos’s methods.