February 24, 2016
By Alex Keown, BioSpace.com Breaking News Staff
PALO ALTO, Calif. – A new warning for blood testing companies which rely on fingerprick testing for diagnostics, such as California-based Theranos, comes from a Rice University study that says not all drops of blood are the same, the New York Times reported this morning.
According to the new study, published in The American Journal of Clinical Pathology, Rice bioengineers said different drops from the same blood sample produced wildly different results for “basic health measures like hemoglobin, white blood cell counts and platelet counts,” the Times said. Traditional blood tests require a vial of blood drawn with a needle. Companies like Theranos have posited they can accurately determine data from a single drop of blood—which is something that has wide appeal in areas that do not have reliable electricity or people with ample medical training. However, the Rice researchers said in order to match the accuracy from traditionally drawn blood methods, it required the averaging of six to nine drops of blood, the Times reported.
Meaghan Bond, a Rice bioengineering student who was part of the team conducting the study, told the Times that relying on “fingerprick sticks” for blood measures will sacrifice accuracy.
It’s that concern over accuracy that has been at the heart of some criticism levelled at privately-held Theranos, which is valued at about $9 billion. In 2015, the company was hit with multiple allegations over the efficacy of its fingerprick testing. The Wall Street Journal ran a series of articles questioning the reliability and accuracy of Theranos’ testing methods. In response, Theranos said it stood by its technology and questioned the Journal’s use of “inexperienced and disgruntled former employees.”
The company was also cited for some of its laboratory practices called into question by the U.S. Food and Drug Administration as well as the Centers for Medicare and Medicaid Services. In January, the Centers for Medicare & Medicaid Services publicized findings of a November visit to Theranos’ Newark lab where regulators discovered “deficient practices” that “pose immediate jeopardy to patient health and safety.” Regulators said Theranos’ laboratory practices at the Newark site were not in compliance with conditions set forth by the federal Clinical Laboratory Improvement Amendment (CLIA). The letter said the company’s hematology practices at that site “posed immediate jeopardy to the health and safety” of patients. The letter defined immediate jeopardy a situation in which corrective action is necessary due to the laboratory’s non-compliance, which “has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or the health and safety of the general public.”
Following an inspection of its labs earlier this summer by the U.S. Food and Drug Administration, federal regulators called the company’s proprietary Nanotainer tubes an uncleared medical device. Regulators were critical of some of the practices its inspectors observed, including improper classification for its proprietary nanotainer tubes used for blood specimens. The FDA said Theranos’ Nanotainer blood specimen tubes are not properly filed as a Class II medical device, but are instead being identified as a Class I medical exempt device. Other observations made by FDA inspectors include a criticism that a method for addressing complaints regarding a possible failure of the device to meet its specifications were not “reviewed, evaluated and investigated where necessary.”
