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New York, NY \u2013 June 13, 2024 \u2013 <\/em>In a challenge brought by Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences Corporation (GHI), BBB National Programs\u2019 National Advertising Division recommended that Agendia, Inc. modify or discontinue certain claims regarding the superiority of its MammaPrint and BluePrint tests for black women, including claims that GHI\u2019s Oncotype DX test is inappropriate for black women and that it is biased, inaccurate, and inconsistent.<\/p>\n GHI\u2019s Oncotype DX test and Agendia\u2019s MammaPrint and BluePrint genomic tests assess the risk of breast cancer recurrence in early-stage breast cancer patients.<\/p>\n The challenged claims appeared in sponsored advertising content, in posts on all major social media platforms, and on the Agendia website. Agendia\u2019s advertisements are provided to doctors, other medical professionals, breast cancer patients, and caregivers.<\/p>\n Equality of Care\/Bias Claims<\/strong><\/p>\n GHI challenged a two-sided postcard distributed to healthcare professionals with the headline that Agendia and its tests provide \u201cEQUAL CARE FOR ALL\u201d and that \u201cAgendia is committed to addressing racial disparities in breast cancer,\u201d followed by claims including:<\/p>\n The bottom of the postcard says, \u201cNot all Genomic Tests are Created Equal.\u201d<\/p>\n The other side of the postcard shows a comparative chart between the \u201cMammaPrint & BluePrint\u201d vs. \u201cOnctoype DX\u201d and a series of checkmarks indicating differences between the tests. The chart concludes with the claim \u201cEQUAL CARE FOR ALL\u201d checked \u201cyes\u201d for MammaPrint & BluePrint, with no checkmark for Oncotype DX.<\/p>\n The National Advertising Division (NAD) determined that at least one message reasonably conveyed by this advertisement and comparative chart is that GHI does not want equal care for all, a message not supported by the evidence in the record.<\/p>\n Further, NAD concluded that Agendia\u2019s evidence does not provide a reasonable basis for the claim that the Onctoype DX test is biased (along with the negative connotation implied by the word \u201cbias\u201d) and that the MammaPrint test has uncovered this bias.<\/p>\n Therefore, NAD recommended Agendia either discontinue these claims or modify its advertising to avoid conveying the falsely disparaging messages that GHI does not want equal care for all and that its Onctoype DX test is biased.<\/p>\n Superiority\/Singularity for Tumor Identification Claims<\/strong><\/p>\n The National Advertising Division (NAD) determined that Agendia\u2019s evidence does not provide a reasonable basis for the overly broad message conveyed by the claim \u201cOnly MammaPrint & BluePrint results can identify higher risk ER+ tumors in black women,\u201d which appeared on the postcard. Therefore, NAD recommended that Agendia either discontinue the claim or modify it to more accurately reflect the underlying support.<\/p>\n Accuracy of Test Results\/Inconsistent Results Claims<\/strong><\/p>\n The National Advertising Division (NAD) recommended Agendia discontinue claims that MammaPrint results provide \u201cmore accurate predictions\u201d because the evidence does not support that it is \u201cmore\u201d accurate than either prior or competing tests and because the test is not cleared or indicated as a predictive test.<\/p>\n GHI also challenged several claims questioning the reliability of Oncotype DX, a test that Agendia characterized as having lower accuracy in black women and inconsistent results.<\/p>\n NAD determined that the studies Agendia relied on are not a good fit for claims that broadly communicate that Onctotype DX has lower prognostic accuracy or worse outcomes for black women.<\/p>\n Therefore, NAD recommended Agendia discontinue the challenged claims or modify its advertising to avoid conveying the overly broad message that Oncotype DX has lower prognostic accuracy and provides less consistent results for black women than MammaPrint and BluePrint. NAD noted that nothing in its decision prevents Agendia from accurately communicating the results of the studies in a more narrowly tailored manner.<\/p>\n Worse Outcomes for Black Women Claims<\/strong><\/p>\n The National Advertising Division (NAD) recommended that Agendia discontinue claims that attribute worse outcomes for black women with the same Oncotype DX test results as white women or modify the claims to avoid conveying such a message.<\/p>\n Material Connection Disclosures<\/strong><\/p>\n GHI asserted that Agendia posted articles published by Hit Consultant and Stat News featuring Dr. Johnson\u2019s opinions on MammaPrint and Oncotype tests on social media that do not include the material connection disclosures required by the FTC\u2019s Guides Concerning Use of Endorsements and Testimonials in Advertising. Since Agendia confirmed that it does not have a relationship, paid or otherwise, with Dr. Johnson, Stat News, or Hit Consultant, the National Advertising Division (NAD) determined there are no material connection disclosures required on the challenged posts.\u00a0<\/p>\n In its advertiser statement, Agendia stated that it will comply with NAD\u2019s recommendations although it \u201crespectfully disagrees with NAD regarding both the interpretation of and the substantiation for Agendia\u2019s advertising\u201d and \u201chas no current plans to resume the challenged claims.\u201d<\/p>\n All BBB National Programs case decision summaries can be found in the\u00a0case decision library<\/a>. For the full text of NAD, NARB, and CARU decisions, subscribe to the online archive<\/a>. This press release shall not be used for advertising or promotional purposes.<\/p>\n \u00a0<\/p>\n About BBB National Programs:<\/strong>\u00a0BBB National Programs, a non-profit organization, is the home of U.S. independent industry self-regulation, currently operating more than a dozen globally recognized programs that have been helping enhance consumer trust in business for more than 50 years. These programs provide third-party accountability and dispute resolution services that address existing and emerging industry issues, create a fairer playing field for businesses, and a better experience for consumers. BBB National Programs continues to evolve its work and grow its impact by providing business guidance and fostering best practices in arenas such as advertising, child-and-teen-directed marketing, data privacy, dispute resolution, automobile warranty, technology, and emerging areas. To learn more,\u00a0visit bbbprograms.org.<\/p>\n About the National Advertising Division:<\/strong>\u00a0The\u00a0National Advertising Division of BBB National Programs\u00a0provides\u00a0independent self-regulation\u00a0and dispute resolution services,\u00a0guiding\u00a0the truthfulness of advertising across the U.S. The National Advertising Division\u00a0reviews national advertising in all media and its decisions set consistent standards for\u00a0advertising\u00a0truth and accuracy, delivering meaningful protection to\u00a0consumers\u00a0and leveling the playing field for business.<\/p>\n Name: Jennie Rosenberg Tags:<\/b> Name: Jennie Rosenberg New York, NY \u2013 June 13, 2024 \u2013 In a challenge brought by Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences Corporation (GHI), BBB National Programs\u2019 National Advertising Division recommended that Agendia, Inc. modify or discontinue certain claims regarding the superiority of its MammaPrint and BluePrint tests for black women, including claims that [\u2026] Continue Reading \n
See Campaign: <\/strong>https:\/\/bbbnp.org<\/a><\/p>\nContact Information:<\/h3>\n
Email: jrosenberg@bbbnp.org
<\/a>Job Title: Media Relations<\/p>\n
BNN<\/a>, CE<\/a>, Go Media<\/a>, Go Media2<\/a>, GoInvest<\/a>, Google News<\/a>, iCN Internal Distribution<\/a>, IPS<\/a>, Nexis Newswire<\/a>, PR-Wirein<\/a>, Reportedtimes<\/a>, The Newswire<\/a>, English<\/a><\/p>\n<\/div>\n\nContact Information:<\/h3>\n
Email: jrosenberg@bbbnp.org
<\/a>Job Title: Media Relations<\/p>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"