Palo Alto-based novel blood test company Theranos was granted a waiver from the FDA allowing the company to offer its first FDA-cleared blood test, its herpes simplex 1 virus IgG (HSV IgG) test, outside of a lab setting. According to the company, it's the first HSV test to receive the waiver, called a CLIA waiver (CLIA stands for the Clinical Laboratory Improvement Amendments of 1988).
The move is the first official step for Theranos moving into mobile health, as it allows the company's low-cost portable blood tests to be administered in Theranos Wellness Centers and retail pharmacies.
“Receiving this CLIA Waiver is an important milestone in fulfilling Theranos’ mission to provide actionable information at the time it matters,” Elizabeth Holmes, founder and CEO of Theranos, said in a statement. “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. 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.”
A statement from the company also provides some additional details on what the clearance entails, including that it covers the usage of the system by "non-laboratory personnel".
"FDA’s determination came after review, by multiple FDA divisions, of extensive data demonstrating that the test and underlying Theranos System perform at least as well in the field with non-laboratory personnel as by trained operators in a traditional laboratory setting," the company wrote. "Specifically, the Theranos System has built in fault-tolerance to deal with conditions that otherwise would impact results and performance and mitigate errors associated with otherwise unpredictable environments. Theranos provided data demonstrating that certain conditions would not affect the integrity of results reported for its HSV-1 test, including temperature fluctuations, humidity, tilting, power fluctuations, contamination, and storage and shipping conditions, among other variables in samples and conditions."
In a Fortune report on the clearance, the publication described why this is a somewhat novel use of the CLIA waiver.
"Historically, the FDA granted waivers of this kind only to fairly simple, single-function, 'point-of-care' devices—like glucose meters—or to preliminary screening procedures, like pregnancy test strips, whose results must later be confirmed by more authoritative tests performed in a regulated lab by credentialed technicians under the supervision of a pathologist.
Theranos’s tests, which are currently done in regulated labs, are authoritative themselves, like those performed by incumbent rivals Quest Diagnostics and Laboratory Corporation of America, which must also be performed in labs."
Telemedicine has brought various types and pieces of the medical visit to the home including doctor visits via video chat and vital signs monitoring via connected devices and data hubs, but the infrastructure for labs hasn't really changed. Last month, through a partnership with Quest Diagnostics, HealthTap added labs to its video visits, but even that doesn't change the process much for patients -- they still had to make an appointment and visit a Quest Diagnostics location. With this new clearance, Theranos is moving toward a future where labs will be available much more readily.
