The FDA is looking to gain control over Genetic Testing and Medivo will be presenting our views on what value Genomics provides and under what circumstances these tests should be used. Listen to Medivo’s statement to the FDA on Tuesday, July 20th, during Session 3: Direct to Consumer Testing (DTC).
The FDA provides the original rationale behind not reviewing laboratory-developed tests (LDTs), as opposed to their regulatory requirement to review in vitro diagnostics lab tests as medical devices for commercial use:
Initially, laboratories manufactured LDT’s that were generally relatively simple, well-understood pathology tests or that diagnosed rare diseases and conditions that were intended to be used by physicians and pathologists within a single institution in which both were actively part of patient care.
However, things have changed. Genomics have rapidly emerged as a major force in the lab testing sector, with increasing clinical relevance, and most of the organizations who offer them are producing them as LDTs instead of commercial tests. Also, there are more players in the market, besides traditional labs like LabCorp and Quest — for example, 23 and Me, Pathway, Navigenics, and others are creating genetic tests and/or marketing them to consumers. Some are even calling for a new division of FDA to review Genomics services.
In response to these public health risks, the agency [FDA] has concluded that it should exercise its authority over LDTs. The public would then be assured that the tests used in the provision of healthcare, whether developed by a laboratory or other manufacturer, are safe and effective.
The good part about all of this is that the FDA seems to recognize that regulation could lead to decreased innovation and are open to learning more. The public meeting next week is to allow the FDA to learn more about what companies and private citizens have to say about genetic testing – its potential benefits and current limitations.
“It is important that [the tests] be analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations,” said Alberto Gutierrez, PhD, of the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, in letters dated June 10th, 2010.”