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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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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, also was convicted on four counts of fraud, which we covered in “Theranos Ex-CEO Elizabeth Holmes Convicted on Three Counts of Wire Fraud and One Count of Conspiracy to Commit Fraud after Seven Days of Jury Deliberations.”

Balwani and Holmes are now awaiting sentencing.

Both trials examined the dubious claims that Theranos’ technology worked properly during the company’s blazing ascent with both Silicon Valley investors and the media from 2003 to 2014. The company said it could take a few drops of blood from a patient and successfully analyze the specimen using a machine called Edison, although Shultz, Cheung, and others questioned the results.

By 2015, problems with Theranos’ testing began to go public. The company shut down in 2018 after Holmes and Balwani were indicted.

Congress Debates New LDT Regulation

A laboratory-developed test (LDT) is an in vitro proprietary diagnostic test developed and performed by an individual clinical laboratory often to address unmet clinical needs.

Currently, LDTs are regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, and CLIA is administered by the Centers for Medicare and Medicaid Services (CMS).

However, proposed legislation is before Congress that would transfer oversight of LDTs to the US Food and Drug Administration (FDA). The bill, known as the Verifying Accurate Leading-edge IVCT Development (VALID) Act, is now embedded in the larger Senate bill FDA Safety and Landmark Advancements Act of 2022 (S.4348).

Theranos’ saga did provide at least some inspiration for legislators filing the VALID Act. However, Cheung noted that trying to regulate all LDTs based the bad behavior of Theranos’ executives is a complex issue.

“Regulation is always tricky,” she said. “When you take an example of a very extraordinary case and a very specific circumstance [such as Theranos] and try to generalize that in terms of what is the behavior of all labs, you have to be careful.”

Proponents state FDA pre-market approval is needed for in vitro diagnostic tests because they are like medical devices. Opponents counter that the VALID Act would stifle innovation because of the costs involved with FDA review, particularly at academic medical laboratories.

Readers of The Dark Report, a sister publication to Dark Daily, learned recently that a group of nearly 300 pathologists and clinical laboratory directors had asked lawmakers to revise the VALID Act or exempt academic medical labs from it. (If you don’t subscribe to The Dark Report, try our free trial.)

Would FDA Review Have Stopped Theranos Earlier?

Cheung questioned whether FDA review of Theranos’ technology would have averted patient and investor fraud by Holmes and Balwani.

“Would it have been the case that if it was necessary for the FDA to review Theranos’ LDTs, that it could have stopped it? Maybe,” Cheung told AACC attendees. “But you’re also dealing with a company that lied a lot. There were lots of things that Theranos had to submit to CLIA or to CMS in order to say that they were able to test certain types of patients.”

Shultz had similar feelings regarding a hypothetical FDA review of Theranos’ product, which will ring true with pathologists and clinical laboratory professionals who understand medical laboratory compliance and how the FDA regulate diagnostic instruments and kits.

“When you bring something to the FDA, they look at the data. They don’t go in and actually do third-party validation to see if your device works,” he said. “They just look at the data, and the [Theranos] data was largely manipulated. So, if you forced Theranos to go through the FDA process, I’m not sure if it would have prevented [the fraud].”

—Scott Wallask

Related Information:

CLIA Regulations

FDA Wants to Close Regulatory Loophole That Theranos Used

Theranos Whistleblower Tyler Shultz Celebrates Former CEO Elizabeth Holmes’ Guilty Verdict by Popping Champagne with Family Members

Former Theranos Lab Director and Staff Testify in Ongoing Elizabeth Holmes Fraud Trial That They Voiced Concerns about Reliability and Accuracy of Edison Blood-Testing Device