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Elizabeth Holmes- Case Archive
personpersonVictoria SungVictoria SungCelgene scientist who helped evaluate Theranos assay performance.← All People
WitnessCelgene

Victoria Sung

Celgene scientist who helped evaluate Theranos assay performance.

AppearedFederal Criminal Trial
422 lines·3 proceedings·1 mention

About

Victoria Sung testified for the prosecution about Celgene's evaluation of Theranos assays for possible use with blood-based endpoints in the ACE-011 renal clinical trial. She described Celgene's interest in the platform's small blood-volume requirement, portability, and potential efficiency, as well as its plan to compare the results with validated methods used by established laboratories.

On direct examination, Sung said the Theranos PK and PD results did not align closely enough with the QPS and ACM comparison methods. She identified missing usable results, fluctuations, greater variability, and substantial differences between methods. She testified that Celgene's group did not validate or endorse the technology, stopped further machine deployment and testing, and performed no additional Theranos work after April 2012.

On cross-examination, Sung acknowledged that the Theranos system used whole blood without sample preparation and required less blood. She also agreed that Theranos responded to Celgene's concerns and that Celgene scientists reviewed reports. At the same time, she distinguished her PD responsibilities from PK work handled by others, said her group lacked assay-development and validation expertise, did not know whether milestone payments were made, and confined several answers to matters within her responsibility, knowledge, and recollection.

Trial Record (3)

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

Victoria Sung testified that Celgene's comparison of Theranos assays with established methods did not support validation or further deployment. On cross-examination, she acknowledged practical advantages and scientific review while limiting her account to her own PD work, knowledge, and recollection.

Day 13

DirectVictoria Sung — DirectVictoria SungRobert S. Leach10highlights244lines spoken

Summary

Victoria Sung testified that Celgene compared Theranos assays with established laboratory methods, found inadequate alignment and greater variability, and halted further deployment without validating or endorsing the technology.

Highlights (10)

Quote“SO MY UNDERSTANDING WAS THAT THERANOS WAS DEVELOPING A PLATFORM TO ANALYZE THESE END POINTS THAT WE JUST MENTIONED, AND THAT THEY COULD DO IT WITH A VERY SMALL VOLUME OF BLOOD IN A VERY EFFICIENT WAY, AND THIS WOULD BE A HUGE ADVANTAGE FOR PATIENTS AND FOR HEALTH CARE PROVIDERS, RESEARCHERS, FOR EVERYONE.”— Victoria SungSung described the practical benefits that initially made Theranos's proposed testing platform attractive to Celgene.Open in transcript →
testimony highlightSung explained that Celgene proposed comparing Theranos results with validated ICON assays before deciding whether to use the platform in additional trials.Open in transcript →
admissionSung testified that Celgene neither validated nor endorsed the technology because its comparison testing produced a mixture of aligned and differing results rather than the close agreement Celgene sought.Open in transcript →
Quote“ULTIMATELY WE TRIED TO DEVELOP A NUMBER OF ASSAYS WITH THERANOS AND WE, AS HAD PLANNED, DID THE STANDARD, THE COMPARISON TO THE STANDARD TESTS, AND THERE WAS SOME OVERLAP, BUT WE FELT THAT THE RESULTS DIDN'T MATCH UP OR COORDINATE OR ALIGN AS CLOSELY AS WE WOULD LIKE. AND SO, AT LEAST FOR THIS TRIAL, WE MADE THE DECISION NOT TO MOVE FORWARD.”— Victoria SungSung summarized Celgene's comparison process and its resulting decision not to use the Theranos assays in the trial.Open in transcript →
Show all 10 highlights
testimony highlightReviewing Celgene's PK comparison, Sung confirmed that 14.1 percent of Theranos samples lacked detectable or usable results, compared with less than 2 percent for QPS.Open in transcript →
testimony highlightSung confirmed that 67 percent of samples differed by more than 25 percent between the Theranos and QPS methods and said the result showed the assay had not performed as hoped.Open in transcript →
testimony highlightSung recalled that Nianhang Chen communicated to Theranos that its platform was not up to Celgene's standard for measuring drug amounts in patients' blood.Open in transcript →
Quote“FROM THE BEST I CAN RECOLLECT, SHE COMMUNICATED THAT THE THERANOS PLATFORM WAS NOT UP TO STANDARD FOR MEASURING THE PK OR THE DRUG AMOUNTS IN THE BLOOD OF THESE PATIENTS.”— Victoria SungSung recalled the overall message delivered to Theranos from Celgene's pharmacokinetic evaluation.Open in transcript →
admissionSung testified that Celgene halted further deployment and testing, did no further work with Theranos after April 2012, and never reached the alignment needed to begin a full validation.Open in transcript →
Quote“SO THE FULL VALIDATION WOULD REQUIRE A LOT MORE WORK THAN WE DID, BUT I THINK IT WOULD START WITH BETTER ALIGNMENT OF THE RESULTS FROM THE THERANOS PLATFORM VERSUS THE STANDARD ASSAYS, AND THEN WE WOULD GO FROM THERE TO DO FURTHER WORK IN ORDER TO DEMONSTRATE THAT THE TWO PLATFORMS ARE COMPARABLE, AND THEN THE ADVANTAGES FROM THE THERANOS PLATFORM WOULD THEN COME INTO PLAY WITH LESS BLOOD DRAWN AND SO FORTH. BUT WE NEVER GOT THERE.”— Victoria SungSung directly rejected the premise that Celgene had comprehensively validated the technology and explained where its work stopped.Open in transcript →
CrossVictoria Sung — CrossVictoria SungJohn D. Cline8highlights178lines spoken

Summary

Victoria Sung confirmed that Theranos supplied validation materials reviewed by Celgene specialists, while qualifying her own expertise, memory of later responses, and knowledge of milestone payments.

Highlights (8)

admissionSung confirmed that her Celgene group lacked assay-validation and development expertise and retained an external consultant.Open in transcript →
evidence eventAfter the court admitted Exhibit 13900, Sung confirmed that Theranos sent validation reports for three PD markers and that she likely forwarded them to someone with assay-development expertise for review.Open in transcript →
Quote“YEP. SO I MAY HAVE LOOKED AT THEM MYSELF. BUT, AGAIN, NOT BEING AN EXPERT IN THIS AREA, I'M PRETTY SURE THAT THEY WERE PASSED ALONG TO SOMEONE WHO REVIEWS THESE SORTS OF DOCUMENTS FOR THEIR INPUT.”— Victoria SungSung expressly limited her assay-development expertise and described relying on specialized reviewers for Theranos validation reports.Open in transcript →
evidence eventThe court admitted an email chain stating that Peter Bryan had completed a scientific review of the final PK report; Sung agreed Bryan would have been a reviewer but could not say he was the final reviewer.Open in transcript →
Show all 8 highlights
testimony highlightSung confirmed that Daniel Young responded in detail to Celgene's PK and PD concerns, while qualifying that she did not recall sending a point-by-point reply or holding another call about the response.Open in transcript →
Quote“I DON'T RECALL EVER REPLYING TO THAT EMAIL, BUT, AGAIN, IT'S A LONG TIME AGO.”— Victoria SungSung acknowledged no remembered reply to Daniel Young's response while preserving the qualification that the events were remote in time.Open in transcript →
testimony highlightReviewing the parties' master agreement and statement of work, Sung limited her involvement in the contractual paperwork to occasional consultation about scientific objectives.Open in transcript →
testimony highlightSung confirmed that the statement of work displayed a $500,000 milestone schedule, but she did not know whether the payments were made; she agreed that payment would indicate the responsible scientists had approved the milestone.Open in transcript →

Day 46