Theranos says it's addressing deficient lab results
After a study earlier study found that cholesterol test results obtained through Theranos were different enough than those from large laboratories to impact care decisions, the company acknowledged those shortcomings and said it is taking steps to fix them.
Specifically, Theranos is suspending its cholesterol testing and hiring three medical doctors who are board-certified as pathologists to run the lab.
By suspending testing, Theranos can “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," wrote Theranos Vice President of Communications Brooke Buchanan in a letter published on the company's website. Results found to be in question have also been voided, the company said.
Theranos’ 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 led 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.
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," Buchanan wrote. "But when the company was made aware of the deficiencies we have dedicated every resource to remedy those failures."
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," Theranos wrote on March 24.
"We will continue to work with CMS to ensure every issue has been fixed completely," wrote
Buchanan promised this week to work with the Centers for Medicare and Medicaid Services to make sure every issue gets completely resolved.
"We recognize the critical role they play in the laboratory industry,” she added “and will continue our work to implement best-in-class policies and procedures."
Twitter: @JELagasse
