Genetic Tests Overemphasize Benefits, De-Emphasize Drawbacks


With a drive for increased personalized medicine in cancer based on a patient’s specific tumor genetics and germline mutations, there has been an uptick in the development and marketing of molecular testing directed towards cancer patients.

With a drive for increased personalized medicine in cancer based on a patient’s specific tumor genetics and germline mutations, there has been an uptick in the development and marketing of molecular testing directed towards cancer patients. Because this type of genetic testing remains relatively unregulated, clinicians are wary of websites that market such products to consumers. 

According to a new study, websites that market personalized cancer care services and testing generally overemphasize the benefits of such tests while minimally communicating the limitations. Of the 55 websites analyzed, 85% (47) stated the benefits of personalized cancer medicine while only 27% (15) discussed the limitations of the approach (P < .001). Moreover, these marketed tests often have not been rigorously tested to support their clinical claims.

The results of the study, conducted by the Dana-Farber Cancer Institute in Boston, are published in the Journal of the National Cancer Institute.

The study raises concerns about the type of information patients and consumers receive about personalized cancer medicine.

“While such marketing may help to disseminate information about evidence-based tests, most companies also market tests that have little or no evidence substantiating the ability to improve patient outcomes,” stated the authors.

"Given the disproportionate claims of benefit and promotion of tests that may not be beneficial, we would urge clinicians and patients to critically evaluate online personalized cancer products,” Stacy Gray, MD, AM, medical oncologist and Dana-Farber Center for Outcome and Policy Research researcher told OncoTherapy Network.

Gray and colleagues identified 55 websites that marketed somatic and germline oncology testing as well as services to interpret genetic and genomic results, and physicians and institutions that offered personalized care. Of these, 32 offered somatic analysis.

While personalized medicine is making headway in the treatment of cancer patients, resulting in the use of therapies that target specific tumor aberrations or alterations, much of the tumor's genetic information is currently not actionable. In other words, knowing a mutation or alternation exists does not always mean something can be done about it.

Therefore, consumers and patients need to use caution when reading marketing material and to discuss all testing possibilities with their physician.

"The impetus for the current study is that patients at Dana-Farber often inquire about products and services they find on the internet, and that prior studies found misleading claims on internet genetic testing websites targeted to other types of consumers," Gray told OncoTherapy Network.

Those websites marketing somatic analyses were statistically more likely to market one or more non-standard tests-those that are not supported by evidence of clinical utility in regular oncology practice-compared to standard tests (88% vs 44% P = .04). Standard personalized medicine tests were defined according to definitions set by the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) working group.

For example, six websites offered chemotherapy sensitivity testing even though a recent evaluation by the American Society of Clinical Oncology (ASCO) found insufficient evidence that such testing is useful.

Thirty-one websites were sponsored by commercial companies, 11 by academic institutions, 8 by private institutions, and one by an individual physician. Twenty-nine percent of the commercial sites provided guidance for patients to discuss the testing or service with their physician, and 10% of the websites included a directory of physicians who could provide the offered test or service. Test costs ranged from $99 to $13,000. About half of the commercial websites included cost information.

The effectiveness of internet marketing of these personalized cancer tests and services is not yet clear.

"There are websites that market tests useful in the clinical care of cancer patients," said Gray. About 28% of the websites analyzed, marketed such tests, including EGFR and BRAF mutation testing for targeted therapies for lung and melanoma patients, respectively.

"Even if regulation of the websites becomes a reality, oncology providers will need to guide patients as they navigate decisions about personalized cancer medicine," concluded the study authors.

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