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Elizabeth Holmes- Case Archive
personpersonSurekha GangakhedkarSurekha GangakhedkarFormer Theranos scientist and team manager who led immunoassay development work.← All People
WitnessTheranos

Surekha Gangakhedkar

Former Theranos scientist and team manager who led immunoassay development work.

AppearedFederal Criminal Trial
1,315 lines·25 proceedings·20 mentions

About

Surekha Gangakhedkar testified under court-ordered immunity about her work managing assay development at Theranos and reporting to Elizabeth Holmes. She described early pharmaceutical work, including a GSK evaluation that she characterized as a limited feasibility study rather than formal validation.

Gangakhedkar used contemporaneous emails to explain technical problems involving cartridges, Nanotainers, readers, calibration, missing data, high variation, and several generations of Theranos devices. She said she returned from vacation in August 2013 and unexpectedly learned of plans to launch assays on patient samples, although she understood that no assays had been validated for the relevant devices. She testified that Holmes increased pressure to complete validation and responded to her warnings by saying a customer commitment left little choice but to proceed.

Gangakhedkar said she resigned because she was stressed, unhappy, and concerned about the launch. She retained documents because she feared the launch would go badly and that she might be blamed despite having raised the problems.

Cross-examination defined the limits of her account. Gangakhedkar agreed that she worked in research and development, did not prepare CLIA validation reports, and did not know what happened with validation after she resigned before launch. The defense also questioned her about favorable pharmaceutical-study results and shared meetings; she responded that high-level coordination occurred while detailed technical and problem information generally remained restricted.

The court permitted jurors to learn that Gangakhedkar had received immunity but barred the government from using the grant affirmatively to support her credibility unless the defense opened the door. Holmes later denied imposing validation deadlines and said tests raising concerns were delayed, while also stating that management's treatment of Gangakhedkar's team was wrong and should have been handled differently.

Trial Record (25)

FederalFederal Criminal TrialAug 31, 2021 – Jan 3, 2022Called by prosecution

Surekha Gangakhedkar testified under immunity about Theranos assay development, unresolved device and validation problems, and warnings to Holmes before a planned patient-testing launch. Cross-examination established the limits of her research-and-development role and tested her accounts of information sharing, validation, and earlier assay results.

Day 4

OpeningOpening Statement by the ProsecutionRobert S. LeachMentioned

Summary

The prosecution alleged that Elizabeth Holmes and Ramesh Balwani defrauded Theranos investors and patients through misrepresentations about the company's technology, partnerships, finances, retail rollout, and test accuracy. It previewed insiders, investors, patients, outside organizations, and records that it expected would support the wire-fraud and conspiracy charges.

Mentioned in this proceeding.

Day 6

ProceduralWitness Immunity Application and Ruling1highlightMentioned

Summary

The court approved the government's immunity application for Surekha Gangakhedkar after prosecutors said her counsel indicated she would invoke the Fifth Amendment and the defense took no position.

Mentioned in this proceeding.

Highlights (1)

procedural actionThe government explained that Surekha Gangakhedkar's counsel had indicated she would invoke her Fifth Amendment right if called and that DOJ had approved granting her immunity.Open in transcript →

Day 8

ProceduralEvidentiary Hearing on Witness Testimony, Hearsay, and Immunity1highlightMentioned

Summary

The court addressed email hearsay foundations and allowed disclosure of Gangakhedkar's immunity while barring affirmative credibility bolstering unless the defense opened the door.

Mentioned in this proceeding.

Highlights (1)

rulingAfter hearing competing positions on Gangakhedkar's immunity, the court permitted the fact of immunity to come before the jury but barred the government from using the grant affirmatively to bolster her credibility unless the defense opened the door.Open in transcript →
DirectSurekha Gangakhedkar — DirectSurekha GangakhedkarRobert S. Leach10highlights409lines spoken

Summary

Gangakhedkar described unresolved Edison and Nanotainer problems, rushed launch validation, repeated notice to Holmes, and her decision to resign and retain records after raising concerns directly with Holmes.

Highlights (10)

testimony highlightGangakhedkar characterized the two-day, 30-sample GSK evaluation as a feasibility study rather than formal validation and said she most probably would not have described it as comprehensive validation.Open in transcript →
Quote“BECAUSE AT THIS POINT I THINK I FELT THAT THIS WAS JUST A SINGLE STUDY, SO IN MY MIND IT WOULD HAVE BEEN A FEASIBILITY.”— Surekha GangakhedkarGangakhedkar distinguished the limited GSK study from comprehensive assay validation.Open in transcript →
Quote“SO THERE WERE GENERAL DIRECTIONS FROM MS. HOLMES THAT ANY NEW PROJECTS THAT WE ARE WORKING ON SHOULD BE, THE INFORMATION SHOULD BE LIMITED ONLY TO THE INDIVIDUALS WHO ARE WORKING ON THEM, AND WE SHOULDN'T BE OPENLY DISCUSSING DETAILS OF THE PROJECTS OR THE PLANS WITH OTHER EMPLOYEES IN THE COMPANY.”— Surekha GangakhedkarShe attributed restrictions on internal information sharing to directions from Holmes.Open in transcript →
evidence eventUsing admitted emails, Gangakhedkar described 4.0 testing problems including failed calibration, no TSH response, seven errors in 20 runs, and unresolved system behavior that could require redeveloping assays for the new platform.Open in transcript →
Show all 10 highlights
testimony highlightGangakhedkar said she returned from vacation to learn that Theranos planned to launch assays on patient samples, although she believed the 3.0 and 3.5 devices still had unresolved reliability problems; she described increasing pressure from Holmes and a rushed validation effort.Open in transcript →
Quote“WELL, BECAUSE I DIDN'T THINK THAT THE 3.0 DEVICES WERE READY TO BE USED FOR PATIENT SAMPLES.”— Surekha GangakhedkarShe stated her central concern about using Edison devices in the patient launch.Open in transcript →
evidence eventGangakhedkar testified that no assays had yet been validated for the 3.0 or 3.5 by August 21 and that she asked Sharada Sivaraman to resend Holmes a report documenting continuing 3.0 and 3.5 failures.Open in transcript →
emotional momentGangakhedkar described resigning because of launch concerns, telling Holmes that Edison problems continued, hearing that Holmes felt compelled to launch after promising delivery to a customer, and retaining records because she feared launch problems and being blamed.Open in transcript →
Quote“AND AT THAT TIME SHE MENTIONED SOMETHING ALONG THE LINES THAT WHEN SHE HAS A PROMISE TO DELIVER TO THE CUSTOMER, SHE DOESN'T HAVE MUCH OF A CHOICE BUT TO GO AHEAD WITH THE LAUNCH.”— Surekha GangakhedkarGangakhedkar recounted Holmes's qualified explanation for proceeding with the launch despite the concerns Gangakhedkar raised.Open in transcript →
Quote“SO ESSENTIALLY I TOOK THOSE TO PROTECT MYSELF AND TO HAVE AS A RECORD IN THE EVENT ISSUES CAME UP IN THE FUTURE.”— Surekha GangakhedkarShe explained why she retained contemporaneous documents despite concern about Theranos's nondisclosure rules.Open in transcript →
CrossSurekha Gangakhedkar — CrossSurekha GangakhedkarLance A. Wade1highlight93lines spoken

Summary

Gangakhedkar limited her knowledge to pre-launch R&D and said she did not know the ultimate CLIA validation outcome, while acknowledging extensive assay-development work and favorable results from a two-assay GSK study.

Highlights (1)

testimony highlightGangakhedkar did not accept counsel's proposed certainty that no patient samples were implicated, explaining that she did not know because testing was still being performed in preparation for validation. She also said she did not think the 4-series device had been used in the CLIA laboratory and was unaware of any completed validation for the 3.0 devices when she resigned.Open in transcript →

Day 9

ProceduralEvidentiary HearingMentioned

Summary

The court set an initial protocol for displaying selected Holmes-Balwani messages, confirmed limits on customer-impact testimony, and addressed corrected test reports without deciding all message-specific objections.

Mentioned in this proceeding.

RedirectSurekha Gangakhedkar — RedirectSurekha GangakhedkarRobert S. Leach4highlights35lines spoken

Summary

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.

Highlights (4)

testimony highlightGangakhedkar reaffirmed that she had reliability concerns about the 3.0 and 3.5 systems when she resigned and said she told Holmes that she was unsure how the 3.0 launch could proceed.Open in transcript →
Quote“BECAUSE ESSENTIALLY THE WORK WAS DEVELOPMENT AND, I MEAN, WE WERE USING THE 3.0'S FOR DEVELOPMENT PURPOSES. WE WERE, LIKE, AWARE THAT THERE WERE FAILURES THROUGH THAT DEVELOPMENT PROCESS. AND THE UPGRADE DATA THAT WE WERE SEEING IN THE 3.5, THE RECENT 3.5 RUNS IN THE TIME OF LATE AUGUST KIND OF ALSO WAS SHOWING SOME ERRORS. SO IT DID RAISE CONCERNS THAT EVEN THE 3.5'S WERE SHOWING SOME PROBLEMS.”— Surekha GangakhedkarGangakhedkar explained why the completed development work did not resolve her reliability concerns about either device generation at the time of her resignation.Open in transcript →
testimony highlightGangakhedkar explained that development work allowed failed samples to be rerun, unlike her understanding of CLIA validation, and said a completed development report was not enough to test patient samples.Open in transcript →
Quote“SO PRIMARILY IN THE ASSAY DEVELOPMENT, DURING THE DEVELOPMENT WE DO HAVE A FLEXIBILITY TO RERUN SAMPLES WHERE THE CARTRIDGES HAVE FAILED OR THERE HAS BEEN A PROBLEM WITH THE ISSUE, BECAUSE WE'RE TRYING TO UNDERSTAND IF OVERALL THE ASSAY IS BEING DEVELOPED. IN THE CASE OF A VALIDATION, I DON'T THINK WE HAVE THAT FLEXIBILITY TO RERUN SAMPLES AND REEVALUATE.”— Surekha GangakhedkarShe drew a substantive distinction between flexible research-and-development work and the more constrained validation process required before patient testing.Open in transcript →

Day 10

ProceduralText Message Admissibility Hearing and RulingsMentioned

Summary

The court resolved disputed Rule 106 text-message designations, allowed journalist-related messages for notice and knowledge with a limiting instruction, ordered one name redacted, and left other evidentiary objections open.

Mentioned in this proceeding.

Day 11

Day 12

CrossAdam Rosendorff — CrossAdam RosendorffLance A. WadeMentioned

Summary

Defense counsel challenged Adam Rosendorff with his government-interview history, prior testimony, and laboratory records while examining his CLIA responsibility, management constraints, the restricted September 2013 launch, assay validation, and Theranos's quality and reporting systems.

Mentioned in this proceeding.

Day 13

Day 19

Day 21

DirectDaniel Edlin — DirectDaniel EdlinJohn C. BosticMentioned

Summary

Daniel Edlin described concealed demonstration errors, selective removal or reframing of test results, third-party processing, and internal technical problems. He also linked Holmes to report review, revised external communications, and detailed approval of website content while qualifying the limits of his own technical knowledge.

Mentioned in this proceeding.

Day 22

CrossDaniel Edlin — CrossDaniel EdlinKevin M. DowneyMentioned

Summary

Defense counsel used Daniel Edlin's resumed cross-examination to characterize Theranos's military projects as customized evaluations and its demonstrations as varied, labeled processes distinct from clinical testing. Edlin denied deceptive intent but maintained limits on his technical knowledge and confirmed that SOCOM never performed its planned experiment.

Mentioned in this proceeding.

Day 35

Day 38

DirectElizabeth A. Holmes — DirectElizabeth A. HolmesKevin M. Downey1highlightMentioned

Summary

Holmes described Theranos's 4 Series development, Walgreens and Safeway partnerships, clinical validation, FDA disclosures, marketing, investor communications, and financial projections. She admitted adding pharmaceutical logos to Theranos reports and regretted how that was handled, while attributing limited disclosure of modified commercial analyzers to trade-secret advice.

Mentioned in this proceeding.

Highlights (1)

Quote“BECAUSE SUREKHA HAD WORKED WITH OUR TEAM AT OUR COMPANY FOR YEARS. SHE HAD DONE GREAT WORK, AND HER TEAM WAS WORKING HARD, AND THIS IS THE WRONG WAY TO TREAT PEOPLE.”— Elizabeth A. HolmesHolmes acknowledged that the management response to Gangakhedkar's team was improper.Open in transcript →

Day 42

ProceduralGovernment Motion to Exclude Late-Produced DocumentsMentioned

Summary

The government sought exclusion of late-produced GSK-related documents under Rule 16, while the defense argued that cross-examination had only recently made them relevant; the court expressed fairness and evidentiary concerns but did not rule in the supplied record.

Mentioned in this proceeding.

CrossElizabeth A. Holmes — CrossElizabeth A. HolmesRobert S. LeachMentioned

Summary

Holmes acknowledged that Theranos devices were not clinically deployed with the military, that the company used third-party analyzers, and that key disclosures to investors, Walgreens, and Roger Parloff omitted or misstated aspects of actual laboratory operations. The prosecution also confronted her with divergent revenue projections, laboratory warnings, prototype limitations, special investor-visit workflows, and her knowledge of the troubled 2015 CMS inspection.

Mentioned in this proceeding.

Day 44

Day 46

ClosingClosing Argument by the ProsecutionJeff SchenkMentioned

Summary

The prosecution argued that Holmes knowingly deceived investors and patients, linked the documentary and testimonial record to the conspiracy and wire-fraud elements, rebutted the principal defense themes, and requested guilty verdicts on all remaining counts.

Mentioned in this proceeding.

Day 47