Theranos, the blood testing startup, is in a row with federal regulators for not meeting quality control standards mandatory in its Newark, Calif., lab.
A Wall Street Journal report says that Theranos conducted hematology blood test on 81 patients over a period of six months in 2015. These tests were performed despite getting inaccurate results. According to the federal inspection report seen by the reporters, there are several other lapses in following correct procedure that could have jeopardized patients' safety.
Federal Centers for Medicare and Medicaid Services (CMS) sent a summary letter which detailed "serious deficiencies" in five aspects, and one of them was hematology. As these hazards were highlighted, Theranos brought more personnel onboard in its Newark lab, apart from Kingshuk Das, board-certified pathologist.
In a statement on the company's website, Das, the company's newly appointed lab director in California, said that following the report, the company has improved its labs. "We have conducted assessments to identify any patients affected or having the potential to be affected by the issues identified by CMS, and we have no reason to believe that these issues have affected patients' health," he said.
Company spokesperson Brooke Buchanan added that the tests in the report were "run on conventional equipment using venipuncture samples," and the tests did not affect more than 40 patients.
Theranos became popular when it boasted about its unique technology, a machine it called Edison. According to the company, this machine was capable of performing a multitude of tests, including tests for measles and HIV, by just taking a few drops of blood. The company's founder, Elizabeth Holmes, a Stanford dropout, has been under scrutiny since October 2015, when the U.S. Food and Drug Administration called its specimen-collection kit as an "uncleared medical device."
Even though Theranos has achieved approval for a herpes test, it is still awaiting FDA approval on many other tests. Until that happens, the company is using conventional blood-testing machines. Ninety percent of the tests performed by Theranos are conducted in its Arizona lab.
