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| TWENTY-TWO |

La Mattanza

he early days of July 2015 brought two pieces of good news for
Theranos. The first was that the FDA had approved the
company’s proprietary finger-stick test for HSV-1, one of two
strains of herpes virus. The second was that a new law Arizona had
passed allowing its citizens to get their blood tested without a doctor’s
order—a bill Theranos had practically written itself and heavily
lobbied for—was about to go into effect.

The company celebrated these milestones by throwing a Fourth of
July party at the new headquarters on Page Mill Road. The festivities
started in the cafeteria with rousing speeches from Holmes and
Balwani and then moved outside to the building’s courtyard, where an
open bar, catered food, and techno music awaited employees.

Theranos touted the herpes test approval as proof that its
technology worked, but I remained deeply skeptical. In laboratory
parlance, the herpes test was a qualitative test. Such tests provided
simple yes-or-no answers to the question of whether a person had a
certain disease. They were technically much easier to get right than
quantitative tests designed to measure the precise amount of an
analyte in the blood. Most routine blood tests were quantitative ones.

I called a source of mine who was high up in the FDA’s medical-
device division. He confirmed my thinking. The herpes test approval
was a one-off clearance that was in no way a blanket endorsement of
Theranos’s technology, he said. In fact, the clinical data the company
had submitted to the agency for a number of its other finger-stick tests