Online ads for genetic cancer tests that promise to identify the best treatment “to kill your cancer” and match the “right drug to the right patient" may not be painting an accurate picture for consumers. Notably missing from many—relevant details of the tests' limitations and evidence of their clinical benefit, a study finds.
As innovations geared toward personalized medicine proliferate, oncologists and medical geneticists say regulation is needed to rein in disproportionate claims. In the meantime, patients and clinicians should approach online claims with a critical eye.
“There are very important limitations that, in general, people should be aware of, but they are not widely reported on websites that market personalized cancer care,” said Dr. Stacy Gray of the department of medical oncology at the Dana-Farber Cancer Institute in Boston. The challenges in genomic data interpretation, the possibility of tests not working and the potential of false positives, all fall into that category, she noted.
Gray is one of six authors of a new study that analyzed 55 websites that either marketed genetic cancer tests or offered interpretive services or personalized cancer care between December 2012 and January 2013. While 44 sites touted benefits such as the potential for personalized therapies and targeted treatments, less than one-third shared limitations.
“The paucity of genetic testing regulation may undermine high quality cancer care if unproven products are promoted,” the authors wrote in the study published Thursday in the Journal of the National Cancer Institute.
Government regulation of genetic testing remains limited, but the topic has elevated in priority in recent months.
In February, California-based 23andMe was granted approval by the Food and Drug Administration to market the first direct-to-consumer genetic test to detect an inherited skin disorder called Bloom syndrome.
In January, the Obama administration proposed $215 million in funds as well as new regulations for precision medicine. One of the goals is to address difficulties in assessing the safety and efficacy of genomic sequencers and the tests that analyze their data.
Most are familiar with the Clinical Laboratory Improvement Act, which regulates clinical human laboratory testing in the U.S. But the main focus of that act is on labs' abilities to perform with acceptable proficiency, not the individual tests conducted inside those labs.
“That leaves open a large gap,” said Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, which funded the new JNCI study. “The reality is any medical laboratory can develop and market a test, with limited oversight, for whatever purpose they decide.”
Marketing language often becomes more general as innovations are introduced, but companies aren't necessarily trying to defraud, said Dr. Michael Watson, executive director of the American College of Medical Genetics and Genomics.
“It's not that they are inaccurate, it's more that there are things we don't know yet,” he said. “And often (manufacturers) are marketing to physicians who are less likely to be well informed about genetics, which gives them an advantage in selling it.”
Watson agreed that FDA oversight can be beneficial, but said some checks and balances will likely come from insurers. “The real de facto regulator has been the payers, and whether or not they are convinced of the validity and utility to pay for a test or not,” he said.
Researchers of the JNCI study found that more than half of the for-profit commercial websites that marketed specific tests or services mentioned costs, which ranged from $99 to $13,000.
Several of the commercial sites alluded to insurance or reimbursements, but Gray said the information “was far from ubiquitous in terms of addressing whether or not these would be out of pocket or covered by an insurance company.”
The majority of the websites evaluated were commercial entities, 20% academic institutions, 15% private institutions and 2% individual physicians.
To conduct the analysis, researchers searched Google, Yahoo and Bing for key terms and generated over 4,900 websites. They narrowed the number of companies to 55 by determining if their site was marketing or selling germline (inherited DNA) or somatic (tumor DNA) tests, or if they advertised personalized cancer care or interpretation services.
There are several genetics tests widely supported by evidence incorporated into guidelines and are helpful for specific patient populations. For example, experts point to the epidermal growth factor receptor gene test for lung cancer, and testing for abnormal KRAS genes, which are common in colorectal tumors. There are also many others for which genetic testing is promising.
However, without oversight even claims made in good faith are not subject to the scientific rigor needed to determine effectiveness and appropriate use.
“Clearly, genetic analysis is making real differences in the lives of patients,” Lichtenfeld said. “But when we are inundated with opportunities, we have to be careful to validate, and make sure those opportunities apply to the care of our patients in a truly beneficial way.”
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