EDITOR'S PAGE
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In February, Cambridge Healthtech Institute (Needham, MA) held its 15th annual International Molecular Medicine Tri-Conference in San Francisco. In his presentation at this conference, John L. Bishop, chief executive office at Cepheid (Sunnyvale, CA), stated that now is the time to expand molecular diagnostics out of the specialty laboratories and into the central labs and beyond, including emergency departments and physician offices. Bishop also predicted that such decentralization of molecular testing could be possible by as early as next year.
In order for Bishop’s predictions to become a reality, the IVD industry will have to address many significant hurdles, in particular the regulation of molecular diagnostics. Such regulation has been a controversial and contentious issue, primarily due to laboratory-developed tests. Many clinical labs have been developing and running their own genetic tests (so-called home brews) that did not obtain FDA market approval. For many years, IVD manufacturers have been crying foul, saying this current regimen creates an uneven playing field that skews the molecular testing market in the labs’ favor.
In an effort to explore such regulatory gaps, the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) has been working on a report on genetic test oversight for the past year (see Trends & Perspectives, page 16). Among the recommendations in its report, SACGHS suggested that FDA should be involved in regulating all genetic tests, including laboratory-developed home brews.
However, one of the major problems with this recommendation is that FDA’s resources are limited. Steven I. Gutman, MD, director at FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), admitted in his presentation at the conference that OIVD would currently be unable to take on the added extra workload of overseeing and approving all laboratory-developed tests.
AdvaMed (Washington, DC) may have found one possible solution to this lack of resources problem. The organization has outlined a proposal to modernize IVD regulations (see Trends & Perspectives, page 14). This proposal is based on adopting a risk-based regulatory approach that would focus limited FDA resources on novel technologies with the highest risks. By facilitating the regulatory process for lower-risk tests, FDA could devote more of its resources to overseeing all genetic tests.
While AdvaMed’s proposal may not offer the ideal solution, it is at least a way to start addressing this ongoing problem of regulating molecular diagnostics. While the decentralization of molecular testing may not happen next year, the IVD industry should try to make it happen sooner rather than later.
