Theranos gets FDA Approval for out-of-lab tests– better for patients

Theranos gets FDA Approval for out-of-lab tests– better for patients

New blood pric test for Herpes is easier, cheaper and available out of a laboratory.

The lab company Theranos, which was founded in 2003 by then 19 year old Elizabeth Holmes, received a groundbreaking FDA approval yesterday. The new ruling allows Theranos to perform a specific blood assay test which detects the Herpes Simplex virus (HSV-1) for the sexually transmitted disease.

Theranos received what is termed a CLIA (Clinical Laboratory Improvement Amendment of 1988) waiver from the FDA which allows an exemption from the mandate that all blood testing be done in a CLIA certified laboratory.  This waiver indicates that the FDA saw compelling evidence that the Theranos test performed in the non-laboratory environment was virtually non-contestable in its accuracy even when administered by minimally trained staff.

This follows a pattern of loosening and changing regulations by the FDA. This change could portend a real boon for both Theranos and patients and their caregivers. This means that the Theranos test can be administered in the Wellness Centers the company owns as well as physician offices and hospitals as FORTUNE reports.

The test meets Theranos’s promise to charge no more than one half the Medicare payment rate to all patients thus reducing the expense of the test.

It also is easier and faster and less painful for patients, as it only requires a few drops through a pinprick collection versus the venipuncture and vial fill in laboratory method employed by Theranos’ competitors, Laboratory Corporation of America and Quest Diagnostics. That combined with the convenience of eliminating the step of going to a separate lab for blood draws promises patient ease and speedier results.

While this goes a long way to founder Holmes’ original goal, “to facilitate the early detection and prevention of disease by making “actionable information accessible to everyone at the time it matters most.”

Towards that goal, her company is said to half another 120 tests ready for submission for approval to the FDA. One that has garnered particular attention is a bedside test for the Ebola virus. Though still a rumor, former US Sec of State and Theranos Board Member, George Schultz inadvertently tipped the media off to the test last winter.

 

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