Theranos verifies California lab deficiencies saying 'we've made mistakes in the past'.
Results for total cholesterol were found to be an average of 9.3 percent lower than those obtained through clinical laboratories Quest and LabCorp.
Elizabeth Holmes, Theranos CEO
Theranos Inc., which offers cholesterol testing via skin-pricking, has acknowledged deficiencies in its Newark, California laboratory and says it has taken steps to address the issue.
Earlier this week, a study found that cholesterol test results obtained through Theranos were substantially different than those from large laboratory companies, implying that doctors' medical decisions could be thrown off by Theranos-acquired results.
The company's results for total cholesterol were found to be an average of 9.3 percent lower than those obtained through clinical laboratories Quest and LabCorp. This lead researchers to surmise that in some instances, doctors may inappropriately begin, or fail to begin, statin therapy, a drug-based regimen that aims to prevent heart disease.
[Also: Theranos cholesterol test results called into question by Icahn School of Medicine study]
The tests are widely available to consumers at Walgreens drugstores. A federal inspection of the company's Newark lab in January found deficiencies that put the lab at risk of losing its federal certification if not resolved, reports say. In reaction, Walgreens shut down one of Theranos' clinics.
"We've made mistakes in the past," said Theranos Vice President of Communications Brooke Buchanan in a letter published on the company's website. "...but when the company was made aware of the deficiencies we have dedicated every resource to remedy those failures."
Theranos has hired a new full-time lab director who is an M.D. and board certified pathologist, as well as two co-lab directors, who are also M.D. and board certified pathologists, to run the lab.
The company also suspended its cholesterol testing, which according to Buchanan, "allowed us to ensure comprehensive resolution of any issues identified by CMS, or identified in our own reviews, before patients are tested on any of the instruments impacted." Results found to be in question have also been voided.
[Also: Theranos signs with AmeriHealth, brings tests to Medicaid patients
The statement is an about-face from comments Theranos made in a March 24 letter to the Journal of Clinical Investigation, in which it claims the report, conducted by researchers at the Icahn School of Medicine at Mount Sinai, contained "false and misleading statements."
"It has produced a flawed and inaccurate study and we are disappointed that any journal would accept this study for publication," wrote Theranos on March 24.
"We will continue to work with CMS to ensure every issue has been fixed completely," wrote Buchanan. "We recognize the critical role they play in the laboratory industry, and will continue our work to implement best-in-class policies and procedures."
Twitter: @JELagasse
