March 29, 2016
By Alex Keown, BioSpace.com Breaking News Staff
PALO ALTO, Calif. – Embattled blood-testing company is once again facing scrutiny for its technology as a new study in the “Journal of Clinical Investigation” raises more questions about the accuracy of the company’s single-drop blood tests.
The testing was conducted by the Icahn School of Medicine at Mt. Sinai, which compared privately-held Theranos’ methods to more traditional testing methods of larger companies Quest Diagnostics and Laboratory Corporation of America Holdings .
Theranos has been criticized for not publishing the data behind its own blood tests. This new data from the researchers raises additional concerns about the efficacy of Theranos’ single-blood-drop testing. The researchers looked at blood tests results from Theranos as well as the two other companies. Many of Theranos’ testing, including for triglycerides and red blood cell counts, were in agreement with tests performed by the other two companies.
“Indeed more than 92 percent of collective measurements reported from LabCorp and Quest, and greater than 87 percent of the measurements returned from Theranos, were within normal ranges,” the study said.
However, according to the study, Theranos’ reporting of cholesterol and white blood cell counts was more likely to show abnormal results as the more traditional testing conducted by those other companies, Bloomberg reported. The researchers said Theranos was 12.5 times more likely to say it could not get results from a sample when it came to cholesterol levels. Theranos testing was 60 percent more likely to report levels that were too low or too high.
“This increase in abnormal test results can have negative consequences for medicine in the form of extra testing, additional patient visits to clinics/hospitals, and added doctor services, all of which result in additional costs and burdens to patients or to the healthcare system and are potentially harmful, if the abnormal tests were misdiagnoses,” the study authors said.
In a response letter to the Journal, Theranos contested the methods and conclusion of the study. Theranos also noted that one of the study investigators is on the board of bioinformatics company NuMedii, a competitor of Theranos. Theranos also contested the testing methods of the study, saying they do not represent Theranos’ normal practices and are “contrary to Theranos CLIA Lab Collection Procedures.” Theranos also contested the lack of correlation data between laboratory results, as well as “accepted reference methods for the tests being evaluated.” BioSpace reached out to Brooke Buchanan, Theranos’ vice president of communications for additional response, but had not heard back by time of publication.
The study is the latest in a series of bad news for Theranos, which faced intense scrutiny since late 2015. For the past six or so months, Theranos has been under fire for the efficacy of its blood testing products as well as conditions at a Newark, Calif. lab, raised after an inspection by the U.S. Centers for Medicare and Medicaid Services. The USMMS said the company’s hematology practices at that site “posed immediate jeopardy to the health and safety” of patients. There were also concerns Theranos sent results of blood tests back to 81 people taking blood thinners for a test called PT/INR, a blood test that measures how long it takes blood to clot. Accuracy is crucial for blood thinner testing so doctors will be able to appropriately adjust dosages for patients. Business Insider, citing the Wall Street Journal, said laboratories use a deviation rule for testing blood thinners due to the trickiness of accuracy, but the Theranos results were outside those parameters.
The concerns raised by the CMMS jeopardized Theranos’ relationship with Walgreens, the company’s biggest source of revenue. More than 40 Walgreens stores in Arizona offer Theranos blood tests. Walgreens has considered severing its relationship with Theranos, according to reports.
A recent study conducted at Rice University questioned the efficacy of Theranos’ blood tests that use a single drop of blood. 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.” 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.
