Shultz and fellow whistleblower Erika Cheung spoke to clinical laboratory scientists and attendees at the AACC Annual Scientific Meeting in Chicago
Two whistleblowers who raised concerns about the accuracy of Theranos’ blood test results offered thought-provoking comments on how the maligned company operated within current requirements for clinical laboratory-developed tests (LDTs) during last week’s American Association of Clinical Chemistry (AACC) Annual Scientific Meeting.
“The laboratory-developed test loophole that Theranos exploited should be closed,” said Tyler Shultz, who complained about Theranos’ inaccurate testing to regulators and The Wall Street Journal. Both Shultz and fellow Theranos whistleblower Erika Cheung were former employees at the now-defunct company.
“There are a lot of good use cases for LDTs, so they shouldn’t all be shut down,” Shultz continued. “But in general, I do think that if FDA-cleared clinical laboratory tests are available, those tests should be used instead of a homebrew test that hasn’t been held to the same standard that an FDA-cleared product has.”
In July, a jury found former Theranos President and Chief Operating Officer Ramesh “Sunny” Balwani guilty of 12 counts of wire fraud and conspiracy to commit wire fraud, which Dark Daily covered in “Tale of Two Trials: Unlike Ex-Theranos CEO Elizabeth Holmes, COO/President Ramesh ‘Sunny’ Balwani Found Guilty of All Charges.”
In January, Theranos’ founder and former CEO, Elizabeth Holmes,...
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