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. 2015 Mar 4;107(5):djv030. doi: 10.1093/jnci/djv030

Table 1.

Examples of benefit and limitation marketing claims from those websites providing benefit or limitation information*

Marketing claim subtype No. (%) Examples of marketing claims
Benefit subtype 47 (100)
Tailor/personalize your therapy 44 (94) “Personalized oncology means to match the right drug to the right patient at the right time.”
“By identifying the alterations in each tumor’s information pathways, molecular profiling enables the individualization of a patient’s treatment by matching those tumor alterations with one or more drugs.”
Identify more effective treatment 31 (66) “Every option we present to you has passed rigorous scrutiny and has been proven to have a direct and positive impact on the treatment of your particular form of cancer.”
“Our laboratory analyzes your tumor’s response to 8–16 drugs and combinations to identify which treatments will work best to kill your cancer. Why use your body to investigate a drug’s effectiveness, when we can garner the results safely and in a timely manner?”
“Similarly, no good doctor should attempt to choose drugs based solely on genomic analyses…. By testing your tumor in its native state, ‘functional profiling’ performed at (our company) takes not just your genomic make-up into consideration, but your cells’ entire biology.”
Outcome benefit 22 (47) “Through these enhanced treatment options our patients experienced a greater life expectancy, often with significantly less side effects than standard treatment.”
“This late stage pancreatic cancer patient’s life was extended five years by (our product)-guided treatment.”
Identify clinical trials 16 (34) “A clinical trial matching service…which helps connect each patient with relevant clinical trials based on each patient’s tumor type and unique tumor molecular profile, clinical history, and personal considerations.”
Decrease side effects 14 (30) “We want you to have the peace of mind that comes from knowing you are doing everything you can to maximize the success of your treatment and limit treatment side effects as much as possible.”
Improve prevention/risk prediction 10 (21) “Individualized, personalized, comprehensive cancer care may yield the best results. Early detection of cancer and preventative measures are offered to every patient.”
Cost savings 10 (21) “Reduce trial and error at the prescription pad, genetic testing is a tool for better patient care, greater accuracy, lower costs, enhanced care, that is our promise.”
Benefit to physicians 6 (13) “With the documentation and education (our company) provides, your doctor will have the information they need to understand the value of these additional/optional tests and treatments.”
Access to cutting-edge technology/ new models of care 2 (4) “(Our company) has also developed technology that uses patient-specific tumor alterations to create a simple blood test for tumor detection and monitoring.”
“Our team has helped patients become aware of, and gain rapid access to, innovative treatments that were not initially prescribed by their oncologists.”
Psychological benefits 6 (13) “If you want the peace of mind that comes from knowing that you are doing everything possible to beat your cancer with the least amount of side effects and the shortest recovery time possible, let (our company) prepare a (personalized plan) for you.”
Limitation subtype 15 (100)
Test failure 6 (40) “Although unlikely, in 8–10% of cases, testing cannot be completed.”
Negative result 3 (20) “It is possible that your tumor does not have any of the mutations tested.”
Challenges of data interpretation 3 (20) “The sheer volume of data produced by next generation sequencing far exceeds the ability of individual physicians, drug developers and healthcare providers to stay up to date on its potential clinical relevance…. As sequencing costs continue to fall, increased emphasis will be placed on the interpretation of sequencing data.”
Potential for discrimination 3 (20) “Although confirmed cases of genetic discrimination are thankfully rare, the fear of discrimination by insurance companies is one of the main reasons people hesitate to pursue access to their genetic information…”
Lack of benefit of personalized therapy 2 (13) “As yet, there are no solid data available confirming the advantages of a patient-individualized or marker-guided therapy. For that reason, deviation from the standard therapies does not make sense at present.”
False positive/false negative 2 (13) “Next generation sequencing approaches may provide incorrect sequence or mutational data because of insufficient coverage in specific regions of the genome, inability to distinguish highly related human sequences, and sequencing errors.”
Uncertain clinical utility 1 (7) “(Some) reports are based on peer-reviewed, published research where the findings still need to be confirmed by the scientific community. They also include topics where there may be contradictory evidence.”
Ethical/social 1 (7) “Because genetic information is hereditary, knowing something about your genetics also tells you something about those closely related to you. Your family may or may not want to know this information as well, and relationships with others can be affected by learning about your DNA.”
Tests may not be
FDA approved
1 (7) “(The test) has not been cleared or approved by the US Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary.”
Results not intended to be medical advice 2 (13) “This (web) Site Does Not Provide Medical Advice. All of the material provided on the Site, such as text, treatments, dosages, outcomes, charts, patient profiles, graphics, photographs, images, advice, messages, forum postings, and any other material provided on the Site are for informational purposes only and are not a substitute for professional medical advice or treatment.”

* No. = number of websites. % represents the proportion of websites providing the particular benefit/limitation subtype of those websites that provide benefit (n = 47) or limitation (n = 15) information. FDA = US Food and Drug Administration.