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