Consumer health technology company Theranos received approval from federal health regulators to process a complex authoritative herpes blood tests outside of a lab.
Theranos announced on Thursday that its blood test, which can test for herpes simplex 1 virus IgG (HSV-1) using a finger-prick's amount of blood, is now cleared to be administered outside of the laboratory setting. The green light from the U.S. Food and Drug Administration (FDA) followed the test's approval on July 2.
FDA granted the startup, which was founded by Elizabeth Holmes in 2003, Clinical Laboratory Improvement Amendments (CLIA) Waiver giving it permission to use the test in settings outside of traditional laboratories.
Historically, the agency granted such kind of waivers to simple and single-function point of care devices such as glucose meters and to preliminary screening procedures such as pregnancy test strips, the results of which need to be verified by more authoritative tests.
"This is certainly a positive step for making what previously was considered complex lab testing-such as a definitive virus assay-broadly available outside of the classic, central lab setting," said Scripps Translational Science Institute director Eric Topol. "We're seeing the first stage of the creative destruction of lab medicine, and how this important part of healthcare is getting democratized."
The new test can now be used at the company's wellness centers in Arizona, Pennsylvania and California, where samples are collected and tested. Theranos also plans to expand to other locations.
With the new test, individuals can simply walk in, get pricked and check the results online. The company has not yet revealed how its new blood test works but it claims that the fingerprick testing is as accurate as drawing blood from the vein albeit it costs less.
"Having the ability to make our test and system more broadly available in a variety of settings is critical to our aspirations to contribute to public health, as we continually innovate to provide the best laboratory testing services in the world," Holmes said in a statement. "The ability for individuals and their health care providers to receive test results in near real-time will play a pivotal role in bettering diagnostic and treatment decisions."
Theranos, which was founded in 2003 when Holmes was just 19 years old, have over 120 other tests for other diseases including Ebola and hepatitis that it also wants to gain approval from FDA.
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