The processes that occur following the discovery of new blood tests and before their approval for medical use are currently not well understood. A group of Canadian researchers have now investigated the various in-between steps. They found that it takes about 18 years for a newly discovered genetic test to be approved by the FDA.
By Francois Rousseau
The human genome project has significantly improved our understanding of human biology. It has also yielded thousands of new potential DNA blood tests (or biomarkers) to screen, diagnose or follow-up on diseases. However, the technological validation process and adoption of the test by clinics still prove challenging. For instance, there is currently no empirical measure of the chronology and pace of technology transfer of molecular genetic biomarkers.
A team of Canadian researchers decided to investigate this process, including its chronology, for a set of 29 new DNA tests discovered since 1978 that have made it to clinical use. Their aims were twofold. First, they wanted to provide estimates of the time frame between the discovery of a new test and its complete implementation in the clinic. Second, they would compare the various trajectories of tests during their journey towards clinical implementation.
In order to have solid data for each test studied, they identified 11 publicly available “timestamps” for the technology transfer process. These ranged from publication of the initial discovery of each biomarker to FDA (or CE) approval of a commercially available test kit. These timestamps also included, for instance, publication of a patent for the test, clinical guidelines supporting its use, or a formal refund of the test by insurers or by public health care systems.
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Commercial approval may take decades
The researchers made some astonishing observations, which were recently published in Clinical Chemistry and Laboratory Medicine. First, they found a lot of variation between the timelines – some biomarkers developed faster than others. Second, it took an unexpectedly long time between the discovery of a new biomarker and its implementation. The median time between discovery and clinical availability of tests was 9.5 years, but varied from one year to 24 years. The most frequent final step of implementation was FDA or CE approval of a commercial test kit. This took a median of 18 years with a minimum of 7 years and a maximum of 38 years.
The researchers conclude that new genetic tests (and possibly all biomarkers as well) take a significant time to reach implementation in the clinic from initial discovery. They propose that further work is now needed to pinpoint key factors and barriers that will need to be tackled to allow for improving and streamlining this process for new tests that can improve patient management and health outcomes.
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