stand the complexity of genomic tests and there is confusion about their true usefulness.


NCCS has adopted several specific positions on matters involving genomic diagnostic tests. It supports vigorous FDA oversight of these tests but with the recognition that a clearly defined regulatory pathway is needed, especially for companion diagnostics. The main concern is that uncertainty in the current regulatory environment will lead to inefficiency and slow progress. NCCS is also very concerned about finding ways for people with cancer to get their questions answered by health care providers at the point of clinical decision making. Cancer treatment planning is a very complex process that is becoming even more complex. People need information and time to understand the implications of the choices they are offered.


Cancer care is at the forefront of the development and use of genomic diagnostic technologies, said Gorman. As a cancer survivor, he wants these diagnostic tests to reduce uncertainty and help in the management of resources. This requires coordinated care and a full understanding of the use and implications of these tests by care providers. Many people seek out second opinions, and it is not uncommon for the pathologist at a second cancer center to have a different conclusion from the initial diagnosis. Questions then arise as to whether the pathology has been correctly interpreted and whether a patient might have to face repeat tests and costs. Without trust in the entire care team to properly advise a patient’s treatment, this may prove to be a significant obstacle for moving these new technologies forward.

Severe illnesses may be different from less threatening illnesses with regard to testing and may require different rules, Gorman pointed out.

If investigational interventions begin to enter clinical practice, the subject of that intervention should know that information, Gorman said. This knowledge will temper expectations and may affect choices. However, if this is a pathway that is used, then the interventions should be done in a manner that will generate evidence. Collection of evidence does not need to be through a randomized controlled trial, but it should be systematic, he said. Gorman warned, though, that use of the investigational system needs to be properly vetted to avoid setbacks that can undermine patient trust, harm the field, and delay progress. Third-party oversight may be useful in this regard.

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