Wall Street Journal Exposes Theranos Blood-Testing Fraud in Landmark Investigation

Wall Street Journal reporter John Carreyrou publishes the first investigative article exposing Theranos’ fraudulent blood-testing technology, revealing that the company was using traditional blood testing machines instead of its proprietary ‘Edison’ devices and that test results were inaccurate. The exposé marks the beginning of the unraveling of Elizabeth Holmes’ $9 billion fraud scheme. Despite Theranos’ attempts to intimidate Carreyrou and the WSJ with legal threats from high-powered lawyers, the investigation reveals systematic deception of investors, patients, and regulatory partners including Walgreens.

The article exposes how Theranos exploited FDA regulatory loopholes by classifying its technology as ’laboratory-developed tests’ (LDTs), which the FDA chose not to enforce pre-market review for. This regulatory capture enabled Theranos to avoid disclosing clinical validation data to investors, the FDA, corporate partners, or academic institutions for years. Government regulators repeatedly failed to uncover extensive compliance problems despite multiple inspections, taking Theranos at its word. The case exemplifies how regulatory discretion and lack of oversight enabled systematic fraud in the medical device industry, putting patients at risk while enriching investors and executives through false claims about revolutionary technology that never actually worked.