Saturday, December 3

Arizona Inspectors Tangle with Testing Company Theranos for Failing to Meet Lab Regulations

room with MRI machineA major Silicon Valley lab-testing company is in some hot water after lab inspectors in Arizona found several issues in its practices, management, and general direction.

According to USA Today, lab-testing giant Theranos recently suspended use of its finger-prick blood draw technique after the U.S. Food and Drug Administration raised concerns with the technology. As it turns out, this decision was prompted by Arizona inspectors who questioned the company’s consistent failure to meet basic lab regulations.

The failed inspection centered around four main deficiencies at the lab: proficiency testing; validation of instruments used to analyze blood samples; humidity levels for lab instruments; and blood sample collection methods.

Theranos currently operates retail locations in 40 different Walgreens drugstores across the city of Phoenix. While Theranos officials maintain that these inspection findings were “routine” and have since been resolved, the company is still experiencing a backlash from some of its most valued partners.

According to Fierce Medical Devices, Walgreens has said it will not open any new Theranos blood-testing centers in its stores until the lab-testing company answers questions regarding the competency of its technology. Additionally, Safeway called off a $350 million deal with Theranos, opting instead to obtain the services from rival Sonora Quest.

Inspection is a crucial part of every industry, from manufacturing to blood-testing. In the case of manufacturing, cost-effectiveness is key, and the industrial CT scanning process allows manufacturers to reduce new product inspection and failure analysis costs between 25-75%.

However, for a blood-testing company like Theranos, safety regulations should always trump cost-effectiveness. It seems as if Theranos has prioritized profits over proficiency, which is why the FDA decided to suspend the finger-prick blood draw system.

In response to the findings of the Arizona inspection, Theranos said it would conduct an internal review to potentially revise their procedures. Medical researchers continue to question why Theranos refuses to public release data on its testing methods, though the company recently said it would share data in the near future.

Theranos maintains that it has done nothing wrong and added that the issues found during the inspection have been rectified. As of now, the company is using more conventional blood draws, from a vein, until the suspension on their finger-prick technique is lifted.

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