The US Food and Drug Administration (FDA) gave it’s clearance late last week for a novel and inexpensive testing system for the diagnosis of herpes simplex 1 virus IgG.
The consumer health technology company, Theranos, Inc. said the FDA’s decision provides independent validation of Theranos’ patented finger stick and venous blood testing technology and the ground breaking Theranos System upon which the HSV-1 IgG test is run, as well as the approach that the company has supported for FDA review of Laboratory Developed Tests (LDTs).
The FDA decision involved extensive review of the Theranos System, a highly-automated platform designed to mitigate the human error traditionally associated with the manual processing of samples. The FDA clearance includes the use of Theranos’ Nanotainer™ Tubes for tests run by this method, which allow samples to be collected from just a few drops of blood from a virtually painless prick of a patient’s finger. The Theranos System, including Theranos’ device, analytical software, and Nanotainer™ Tubes, has been fully validated and cleared for use with this test method.
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. Today’s announcement demonstrates that Theranos has met that standard and is an important step in Theranos’ mission to make health information accessible to people at the time it matters, enabling early detection and prevention of disease, and empowering individuals everywhere with information to live healthier lives – a mission that depends on patients knowing they are getting results they can trust.
“We are proud to have received our first FDA clearance,” said Elizabeth Holmes, the founder and CEO of Theranos. “In order to realize our vision of early detection, lab tests must meet the highest quality standards — standards that are comprehensively set by FDA. FDA review is a uniquely rigorous process we undertook voluntarily because we remain deeply committed to ensuring that our systems and all of our laboratory developed tests are of the highest quality, and that patients and their physicians have access to the most accurate information about their health. We look forward to continuing our strong working relationship with the Agency on further applications.”
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 sixty-nine 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.
As a high complexity CLIA-certified laboratory, Theranos subjects its tests to the highest quality standards and independent laboratory audits. FDA does not currently require that LDTs be submitted for review. However, Theranos believes that the rigor of FDA review helps to ensure that tests are properly designed and interpreted, consistently manufactured, and of the highest quality. Earlier this year, Theranos expressed its public support for the Agency’s proposal to strengthen the regulation and oversight of LDTs. A copy of the company’s FDA comment can be found here. Theranos is the first lab to voluntarily commit to submitting all of its LDTs to the FDA for review.
Theranos is deeply committed to transparency in the laboratory testing space. In addition to its commitment to FDA regulation of LDTs, Theranos voluntarily posts the results of its proficiency testing on its website and advocates an unprecedented level of transparency in cost and quality in the clinical laboratory industry. Theranos charges the same prices – clearly posted on its website and in its Wellness Centers – for all tests for all patients, regardless of insurance status.
Theranos’ HSV-1 test costs $9.07 and is one of 153 tests Theranos makes available for less than $10.