Theranos is a Palo Alto based blood diagnostics company founded by the enterprising Elizabeth Holmes. Recently, the company has come under fire from publications such as the Wall Street Journal. It is being claimed that Theranos’ business is heavily reliant on traditional blood diagnostics methods as opposed to the proprietary micro-diagnostic technology which the company was founded on. Criticisms regarding the accuracy of certain in-house lab instruments used by the blood diagnostics company prompted Theranos to release a statement in response to the WSJ on October 16th, 2015. While showing support for the FDA framework, Theranos made the following statement in the press release:

It is not possible to operate under the CLIA lab quality system for Lab Development Tests (LDTs) and the FDA quality systems at the same time.

This statement has drawn attention to the differences between regulatory requirements implemented by the Clinical Laboratory Improvement Amendments (CLIA) versus those used by the FDA in terms of LDTs. In this article, RegDesk takes a closer look at the details behind the news headlines.

What is a Laboratory Developed Test?

According to the Centers for Medicare and Medicaid Services (CMS), the FDA defines an LDT as an in vitro diagnostic test (IVD) that is manufactured by and used within a single laboratory. In order to use these in-house developed tests, laboratories require a certificate from the Clinical Laboratory Improvement Amendments (CLIA). Since LDTs are considered to be “devices” by the Federal Food, Drug, and Cosmetic Act (FFDCA), they are subject to regulation by the FDA. However, the FDA does not always enforce regulatory requirements concerning the safety and effectiveness of LDTs.

Issues of Clinical Validity: CLIA vs FDA

CMS notes that their analytical validity review for LDTs under CLIA has one intended purpose: to determine if a specific test finds what it is supposed to find when laboratories perform testing on patient specimen. This process occurs after the laboratory has already begun using the LDT for testing. Conversely, the FDA conducts an analytical validity review of a test system before it is even on the market. CMS has even acknowledged that the FDA’s analytical validity review is much more centered around the test’s safety and effectiveness than that required by CLIA.

CLIA also does not require LDTs to undergo a clinical validation review. A clinical validation review is used to determine the accuracy of the LDT in terms of its ability to detect a disease in a patient. If a clinical validation is not conducted, the test results may read false negatives in the patient which is extremely dangerous in the case of life threatening diseases. The FDA, on the other hand, does require a clinical validity review of any LDT during the stages of premarket review.

While we hope Theranos will be able to move forward from this controversy, we are glad it has brought the issues of medical device regulation to a wider audience. We hope this review brought a little clarity to your understanding of the current discussion.