PALO ALTO, Calif.--(BUSINESS WIRE)--Theranos, Inc. (Theranos) today announced that its test and Theranos test system for the herpes simplex 1 virus IgG (HSV-1), which was cleared by the U.S. Food and Drug Administration (FDA) on July 2, 2015, has now received a Clinical Laboratory Improvement Amendments (CLIA) Waiver from FDA, permitting its use in locations outside of traditional clinical laboratories. This decision is a significant step forward in further decentralizing Theranos’ lab testing services and allowing them to be provided at the time and places it matters most. The CLIA Waiver is also one more step in Theranos’ commitment to reinvent laboratory services for individuals and their physicians.
FDA has concluded that the Theranos test and technology is eligible for waiver under CLIA. The waiver means FDA determined the Theranos test and technology is reliable and accurate and can be used in a broader set of locations outside of a traditional CLIA certified laboratory, including Theranos Wellness Centers. This is the first HSV test and test system to receive a CLIA waiver.
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. 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.
The waiver categorization therefore allows Theranos to operate its technology both within its CLIA certified laboratories and also within locations outside of its certified laboratories, including Theranos Wellness Centers, currently located in 42 locations in Arizona, one in Palo Alto, California and one in Harrisburg, Pennsylvania. “Receiving this CLIA Waiver is an important milestone in fulfilling Theranos’ mission to provide actionable information at the time it matters,” said Elizabeth Holmes, founder and CEO of Theranos. “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.”
The FDA announcement regarding Theranos’ CLIA Waiver comes shortly after the agency announced its first review and clearance of Theranos’ test and test system for the herpes simplex 1 virus IgG (HSV-1). Theranos provided comprehensive data to the Agency on its test systems and methods, its chemistry, its hardware, and its software in the company’s foundational system and LDT application. Specifically, Theranos provided study data from 818 subjects of varying age and ethnicity, demonstrating that its system could be run accurately using only a finger stick as well as a traditional venous draw across large numbers of Theranos devices, all compared against an FDA cleared, commercially available reference method.
Theranos’ HSV-1 studies included matrix comparison studies across 69 Theranos devices. Use of such a large number of devices in the studies is unusual, as such studies are often run on a single or small number of devices. The larger number of devices allows for comprehensive characterization of variation across devices, which can be a source of variance in data across laboratories. Theranos’ HSV-1 clinical studies also included sensitivity and specificity studies with hundreds of human samples – both capillary and venous, CDC panel testing - which demonstrated 100% agreement with the results provided by CDC, low-prevalence population tests, and other studies.
Theranos also completed full submissions for its HSV-1 IgG test on venous serum, venous plasma, capillary plasma and capillary whole blood, to demonstrate equivalence on its system across the different sample types, in contrast to conventional tests which have only been cleared for venous samples.
Additionally, Theranos demonstrated performance of its test across multiple finger sticks (9) collected from each subject, validating not only the robustness of the assay but also the reproducibility of its finger stick blood collection method and Theranos Nanotainer Tubes for this method.
The FDA’s review process for 510(k) notifications is widely recognized as one of the most rigorous regulatory hurdles in the world for evaluation of the performance, accuracy, and intended use of diagnostic tests. Theranos believes that the rigor of the FDA’s clearance and waiver processes helps to ensure that tests are properly designed and interpreted, consistently manufactured, and of the highest quality. For that reason, Theranos has been working with FDA over an extended period of time to develop a transparent model for FDA review of laboratory developed tests (LDTs), has led the industry by committing to submitting all of its tests for FDA review even though they are not required to do so, and has expressed its public support for FDA’s proposal to strengthen the regulation and oversight of LDTs.
Theranos is leading transparency in lab testing, including committing to FDA review of all of its LDTs and publishing its prices, lab proficiency testing scores, customer satisfaction scores, guest visit times, and more, to realize a system in which individuals become more engaged and early detection and prevention of disease become realities.
Theranos, Inc. is a consumer health technology company founded in 2003 by Elizabeth Holmes. Theranos’ mission is to make actionable information accessible to everyone at the time it matters most. By doing so, Theranos is working to facilitate the early detection and prevention of disease and to empower people everywhere to live their best lives. Theranos offers lab tests in convenient locations in its Wellness Centers in Arizona, Pennsylvania and California, with plans to expand throughout the country.