New York, NY – June 13, 2024 – In a challenge brought by Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences Corporation (GHI), BBB National Programs’ 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’s Oncotype DX test is inappropriate for black women and that it is biased, inaccurate, and inconsistent.
GHI’s Oncotype DX test and Agendia’s MammaPrint and BluePrint genomic tests assess the risk of breast cancer recurrence in early-stage breast cancer patients.
The challenged claims appeared in sponsored advertising content, in posts on all major social media platforms, and on the Agendia website. Agendia’s advertisements are provided to doctors, other medical professionals, breast cancer patients, and caregivers.
Equality of Care/Bias Claims
GHI challenged a two-sided postcard distributed to healthcare professionals with the headline that Agendia and its tests provide “EQUAL CARE FOR ALL” and that “Agendia is committed to addressing racial disparities in breast cancer,” followed by claims including:
- “Black women are more likely to die from breast cancer than white”
- “Only MammaPrint & BluePrint results can identify higher risk ER+ tumors in black women”
- “Agendia’s test provide consistent results in black women as well as in other diverse groups of patients”
- “Oncotype DX Breast RS test has lower prognostic accuracy in Black women”
The bottom of the postcard says, “Not all Genomic Tests are Created Equal.”
The other side of the postcard shows a comparative chart between the “MammaPrint & BluePrint” vs. “Onctoype DX” and a series of checkmarks indicating differences between the tests. The chart concludes with the claim “EQUAL CARE FOR ALL” checked “yes” for MammaPrint & BluePrint, with no checkmark for Oncotype DX.
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.
Further, NAD concluded that Agendia’s 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 “bias”) and that the MammaPrint test has uncovered this bias.
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.
Superiority/Singularity for Tumor Identification Claims
The National Advertising Division (NAD) determined that Agendia’s evidence does not provide a reasonable basis for the overly broad message conveyed by the claim “Only MammaPrint & BluePrint results can identify higher risk ER+ tumors in black women,” which appeared on the postcard. Therefore, NAD recommended that Agendia either discontinue the claim or modify it to more accurately reflect the underlying support.
Accuracy of Test Results/Inconsistent Results Claims
The National Advertising Division (NAD) recommended Agendia discontinue claims that MammaPrint results provide “more accurate predictions” because the evidence does not support that it is “more” accurate than either prior or competing tests and because the test is not cleared or indicated as a predictive test.
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.
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.
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.
Worse Outcomes for Black Women Claims
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.
Material Connection Disclosures
GHI asserted that Agendia posted articles published by Hit Consultant and Stat News featuring Dr. Johnson’s opinions on MammaPrint and Oncotype tests on social media that do not include the material connection disclosures required by the FTC’s 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.
In its advertiser statement, Agendia stated that it will comply with NAD’s recommendations although it “respectfully disagrees with NAD regarding both the interpretation of and the substantiation for Agendia’s advertising” and “has no current plans to resume the challenged claims.”
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