In the news

Firstly, the FDA has expanded on its previous announcement relating to consumer genetic tests and has now indicated that it is intending to regulate all laboratory-developed tests (LDTs), i.e. those in vitro diagnostic tests that are manufactured and offered by the same laboratory (see press release). The FDA is planning a public meeting in July 2010 to discuss how it will regulate these tests, the scope of which will be much broader than just genetic or consumer tests and include myriad diagnostic tests developed and implemented by pathology labs throughout the US. Evaluation and regulation of LDTs has long been a bone of contention within the US, as they fall outside the existing medical device regulation, but this has become more pressing in recent years as the tests have become more complex and more widely offered (for more detail, see Genomics Law Report).

 

Secondly, writing the New England Journal of Medicine, the Directors of both the NIH and the FDA have laid out a roadmap for personalised medicine [Hamburg M & Collins F, NEJM (2010): doi: 10.1056/NEJMp1006304]. It is widely recognised that the financial and regulatory requirements for developing targeted treatments with companion diagnostics are very different from the standard models used currently in either the pharmaceutical or diagnostic industries. To address this issue, the NIH and the FDA will invest in “advancing translational and regulatory science” to "better define regulatory pathways for coordinated approval of co-developed diagnostics and therapeutics, develop risk-based approaches for appropriate review of diagnostics to more accurately assess their validity and clinical utility, and make information about tests readily available.”

 

Thirdly, in a separate move, the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) has announced that it is assembling a task force to tackle the medical issues relating to affordable whole genome sequencing (WGS), focussing particularly on what it will mean for patients and doctors in the US (reported in GenomeWeb News). The staggering rate of development of ever cheaper WGS technologies has created a need to establish the clinical validity and utility of these tools, to assess their [potential impact on clinical practice and pathology services, and to consider their wider ethical and legal implications. The PHG Foundation has already recognised this need, and is working with partners to analyse the health implications of WGS within the UK NHS, focusing particularly on clinical utility for diagnosing inherited diseases and improving cancer care.