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‘Revolutionary’ Fingerprick Test: More Hype Than Substance?

Expert questions company’s claims

The press is hailing a new fingerprick test as a revolution in the health care industry. The test, developed by California-based Theranos, reportedly assesses up to 200 different values from a single drop of blood and can detect indicators of potential medical conditions. With the company valued at $9 billion, its founder, Elizabeth Holmes, is America’s youngest billionaire.

In an article published in Clinical Chemistry and Laboratory Medicine, Dr. Eleftherios P. Diamandis of Mount Sinai Hospital in Toronto, Canada, looks at the success of Theranos’ fingerprick test and concludes that many of the company’s claims do not stand up to scientific review.

Diamandis’ first concern is that Theranos’ laboratory system was never scientifically assessed by an independent organization, as is customary in clinical research. In addition, laboratory results and other data were not made available for peer review and comparison by conventional test methods. Theranos keeps its laboratory system and data in strict secrecy, according to Diamandis.

Theranos claims that with its procedure, test results are available faster and at a lower cost compared with conventional laboratory testing. Diamandis points out, however, that most laboratories deliver test results within 1 to 2 hours; that, for a range of tests, speed is not necessarily beneficial for patients; and that larger laboratories offer their services at significantly lower costs compared with Theranos. The company’s claim that such laboratories require a separate blood sample for each individual test is dismissed by Diamandis, who says that a single tube of blood is sufficient to carry out between 10 and 100 conventional tests. Moreover, many if not all of Theranos’ technological advances are now incorporated into widely used point-of-care devices, according to Diamandis.

The author also questions whether a fingerprick is really less painful than current methods of drawing blood, as claimed in Theranos’ press releases.

Diamandis concludes his paper by calling for open discussion of Theranos’ fingerprick test and its results in appropriate scientific journals and forums to allow better understanding of both the benefits and risks associated with the company’s new procedure.

Sources: EurekAlert; June 29, 2015; De Gruyter Open; June 11, 2015; and CCLM; June 2015.

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