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Federal Criminal Trialtrial-daytrial-dayJohn C. BosticRobert S. LeachKatherine TrefzLance A. WadeSurekha GangakhedkarBrittany GouldAudra ZachmancrossredirectdirectDay 9 - September 21, 2021Gangakhedkar distinguished assay development from CLIA validation and reaffirmed device concerns at her resignation. Zachman and Gould then described conflicting Theranos HCG results, the resulting belief that Gould was miscarrying, and their loss of confidence in the laboratory.
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Day 9 - September 21, 2021

Assay Validation Disputed; Conflicting HCG Results Examined

Judge Edward J. Davila
7Proceedings
4Pages
3Witnesses
2,926Lines
Day 9 of 51
Appearing:

Gangakhedkar distinguished assay development from CLIA validation and reaffirmed device concerns at her resignation. Zachman and Gould then described conflicting Theranos HCG results, the resulting belief that Gould was miscarrying, and their loss of confidence in the laboratory.

Full day summary

Before testimony, the court set an initial protocol for presenting selected Holmes-Balwani messages: remove page and confidentiality information, enlarge the substantive text, and instruct jurors not to infer anything from redactions. Broader relevance and completeness objections remained unresolved. On cross-examination, Surekha Gangakhedkar acknowledged successful assay projects, expanding development totals, regular updates to Holmes, and formal plans for later validation. She maintained, however, that R&D development reports were not CLIA validation reports and that information generally remained restricted outside selected coordination. Gangakhedkar also described recurring criticism of her team and confirmed that she resigned despite Holmes's efforts to retain her. On redirect, she reaffirmed that failures observed on the 3.0 and 3.5 systems caused her to question the planned launch, and she said completed development work did not establish readiness for patient testing. The court later admitted a narrowed, two-page version of Exhibit 3961 after addressing the defense's hearsay objections. Audra Zachman reviewed laboratory reports showing sharply conflicting HCG values for Brittany Gould. Zachman testified that the reported Theranos decline suggested pregnancy loss and that the corrected duplicate value still did not present a reassuring clinical trend. On cross-examination, she limited her expertise to clinical interpretation rather than assay mechanics, acknowledged Theranos's apology and corrective efforts, and said a later chart review found no comparable questioned result with a different clinical outcome. She nevertheless maintained that Gould's result was markedly anomalous and that the experience ended her confidence in referring patients to Theranos. Gould then testified that Theranos's pricing, convenience, and finger-prick marketing led her to use and recommend its services while expecting accurate results. After being told that her HCG numbers were falling, she believed she was miscarrying and discussed possible next steps. Later testing showed that she remained pregnant, and she ultimately gave birth. Gould said the conflicting results caused her to stop using Theranos and referring patients there.

2. Surekha Gangakhedkar — Cross/Redirect (Continued)

Gangakhedkar completed cross-examination and redirect concerning assay development, CLIA validation, Theranos data access, and her concerns before resigning; the court also admitted a narrowed version of Exhibit 3961.

Cross
Surekha GangakhedkarLance A. Wade
1713 lines

Gangakhedkar acknowledged extensive successful assay development, regular updates to Holmes, and formal CLIA-validation planning, while maintaining that R&D reports were not CLIA validation and that detailed information sharing remained limited. She also described team frustration with Balwani's pressure shortly before her resignation.

Redirect
Surekha GangakhedkarRobert S. Leach
85 lines

Gangakhedkar reaffirmed her 3.0 and 3.5 reliability concerns, distinguished development reports from CLIA validation, and described voluntarily giving federal agents documents and an account of Theranos data silos in 2016.

Procedural
Exhibit 3961 Admissibility Hearing and Ruling

The court sustained the hearsay objection to Michael Craig's email if offered for its truth, allowed Ms. Noyes's email, and admitted a narrowed two-page version of Exhibit 3961.

Redirect
Surekha GangakhedkarRobert S. Leach
45 lines

Gangakhedkar reaffirmed that assay development reports did not constitute CLIA validation, described the additional reagent work validation required, and confirmed that Tina Noyes resigned on the same day she did.

Highlights

3. Audra Zachman — Direct/Cross/Redirect

Audra Zachman's testimony concluded with cross-examination and redirect about conflicting Theranos HCG results, her limited knowledge of assay methods, and why Theranos's correction and follow-up study did not restore her confidence. The court then called and swore Brittany Gould.

Direct
Audra ZachmanJohn C. Bostic
480 lines

Audra Zachman testified that conflicting Theranos HCG results led her to warn Brittany Gould of a likely pregnancy loss, while later Quest results and a successful pregnancy caused her to doubt Theranos and stop HCG referrals.

Cross
Audra ZachmanKatherine Trefz
203 lines

Zachman limited her expertise to clinical interpretation, acknowledged Theranos's corrective response and a later comparative study, and confirmed that her broader chart review found few apparent anomalies while maintaining that Gould's result was unusually out of place.

Redirect
Audra ZachmanJohn C. Bostic
73 lines

Zachman said a follow-up study did not restore her confidence and reaffirmed that both the original and corrected Theranos HCG patterns raised serious clinical concerns that did not match Gould's pregnancy outcome.

Highlights

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