CTA: Is there strong consumer demand for DTC personal genomic testing for cancer risk?

Dr Roberts: My sense is that there is broad interest, given how many people have relatives who are affected by cancer, as well as the general public fascination with genetics. In our PGen Study, risk information for several cancers was of high interest to consumers. Breast cancer was highest (67% of those surveyed reported being very interested), with strong interest also expressed for risk of prostate, skin, and colon cancers.

The experience of companies like Color Genomics, which offer a lower-cost alternative to traditional hereditary cancer risk assessment conducted in medical centers, may be instructive here in gauging consumer demand for certain types of cancer genetic testing.

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CTA: In your opinion, should the FDA allow DTC genomic testing for cancer risks? Do you expect the FDA to approve TC cancer-risk testing?

Dr Roberts: I think the answer depends on many factors: the predictive value of a given test, the quality of education materials provided by the company (including potential access to telephone genetic counseling), and available treatment and prevention options for the disorder in question. I believe the FDA’s recent decision does appear to open the door to potential DTC tests in this area.

CTA: One concern about DTC testing is the idea that patients will over-utilize medical resources or seek unnecessary interventions in response to genomic testing results that have unclear clinical implications, such as moderate-penetrance mutations/single-nucleotide polymorphisms (SNPs). Is that concern well-founded, in your opinion? 

Dr Roberts: The limited number of studies to date in this area does not suggest a significant increase in unnecessary tests or procedures in response to DTC testing. Studies like ours, however, suggest that around a quarter of consumers share results with their primary care providers (PCPs) and about 5% ultimately seek out a genetic counselor (GC).

I think it could be argued that in many cases, there would be higher priority uses of these providers’ time than discussing DTC test results, particularly because PCPs are already pressed for face-to-face time with patients in their busy schedules and GCs are relatively few in number nationwide.