Theranos, founded in 2003 by Elizabeth Holmes, plans to revolutionize clinical laboratory testing by offering low cost blood tests at neighborhood drug stores. Eleftherios Diamandis, head of clinical biochemistry at Mount Sinai Hospital in Toronto, thinks this is too good to be true. He challenges the Theranos model in a recent issue of Clinical Chemistry and Laboratory Medicine.
Theranos testing requires just a few microliters of blood, and more than 30 tests can be performed on a single sample, according to Holmes. Blood is collected from the finger into a disposable cartridge, and loaded into a reader for analysis. However, according to Diamandis, this technology has not been independently evaluated, and no results have been shared in peer-reviewed scientific literature.
Theranos claims to offer the same services as a centralized laboratory, but at a fraction of the cost. Diamandis, however, suspects the cost of reagents and consumables to be similar, if not lower, at centralized labs. Theranos insists that a separate vial of blood is required by centralized labs to perform each blood test. Diamandis disagrees, noting that 10 to 100 analytes can be measured on a 7 ml sample of blood with current (low cost) technology.
Above all, Diamandis is most concerned about the public ordering and interpreting their own blood tests, citing a "lack of appreciation of the dangers of self-screening and self-interpretation of results by asymptomatic individuals who are trying to detect occult disease". What's more, centralized labs phased out the multi-parametric panels used by Theranos in the 1980s because they carry a high rate of false positive results.
Diamandis concludes his critique with a call to openly discuss the Theranos approach in the scientific literature. However, he maintains, "their claims of superiority over current systems and practices are speculative, at best".
Sources: Clinical Chemistry and Laboratory Medicine (CCLM). Volume 53, Issue 7, Pages 989-993 DOI: 10.1515/cclm-2015-0356, May 2015, Business Insider, EurekAlert, EmpowHER, Theranos