Dangerous diagnostics? Regulatory reform in the genomic era

Please see this new BMJ article with these key messages:

The rapid growth of the molecular diagnostics sector has prompted concerns about major gaps in the regulatory regime for diagnostic devices;

Many molecular diagnostics are laboratory developed tests, which are currently not tracked or subject to evaluation under medical device regulation;

Risk classification systems for diagnostic devices mean that even in the regulated part of the market tests may not be subject to premarket review;

Regulatory responses to these gaps have been mixed, but EU regulations hold the greatest potential for real improvement.

Holloway BMJ 2019.pdf (864.1 KB)