Laboratory-developed tests are under the regulatory spotlight

A laboratory-developed test (LDT) is a type of in vitro diagnostic that, according to the FDA, must be designed, manufactured, and used all within the same laboratory. In the past, LDTs tended to be assays run by hospital labs on patient samples to assist in speedy diagnosis and help physicians to decide best treatment. Due to their simple and relatively limited nature, LDTs were subject to fewer regulatory requirements than other types of in vitro diagnostics.

Recently, LDTs have become more common and are utilising increasingly complex technology. Concerns have been raised over companies that offer LDTs for high-risk conditions such as heart disease or cancer but do not have the necessary data to support their claims, or whose tests may yield inaccurate results.

A prime example of this is Theranos. Capitalising on many people’s fear of needles, Theranos promised to perform comprehensive lab tests using just a few drops of blood that could be obtained from a finger prick. The allure of Theranos came not just from their seemingly innovative and disruptive technology, but also from their consumer-oriented ethos, which aimed to provide patients with rapid access to actionable test results.

Theranos was founded by Elizabeth Holmes in 2003. Over a decade later, Forbes listed Holmes as the youngest self-made female billionaire and Theranos, having recently announced a partnership with Walgreens, appeared set to revolutionise the healthcare industry.

However, just as astonishing as Elizabeth Holmes’ rise to fame was her subsequent fall from grace. Following a multitude of news articles and academic papers questioning the veracity of Theranos’ supposedly breakthrough Edison technology, on 14 March 2018 the Securities and Exchange Commission (SEC) charged Theranos and Holmes with “massive fraud”.

Theranos’ proprietary analyser only ever received FDA approval for one test, and it is widely alleged that the company used commercially available devices to perform the vast majority of its tests. Furthermore, questions have arisen regarding the accuracy of test results that were obtained using Theranos’ Edison blood-testing device.

In order to settle the SEC’s charges, Holmes not only agreed to a financial penalty, but also accepted a 10-year ban from acting as officer or director of any public company. There now seems little doubt that Theranos exaggerated claims regarding its technology.

With multiple other high-risk LDTs still on the market, the FDA is reconsidering its policy for regulating this type of medical device, although it has yet to publish any new enforceable guidelines.