• Data presented at the 2023 ASCO® Annual Meeting confirms BluePrint® accurately reveals the driving forces behind a tumor’s growth, independent of race
• With over 1,000 Black women enrolled, Agendia’s FLEX trial is the largest prospective cohort of Black women with whole genome and clinical data, fueling critical discoveries of their gene expression

At the 2023 ASCO Annual Meeting, Agendia, Inc., a gene expression profiling company advancing personalized early-stage breast cancer care, reinforces its commitment to progressing research of racial disparities in breast cancer through two poster presentations. Building off the research presented at the 2022 annual meeting, which found that BluePrint identifies stark racial disparities among women with HR+HER2- tumors [1], the data presented at this year’s meeting examines the impact of race on the underlying biology of HER2+ tumors. This data, in addition to substantial growth in enrollment in Agendia’s FLEX trial, demonstrates the importance of understanding how race influences a tumor’s gene expression to inform personalized, biology-based breast cancer care for patients of all racial and ethnic backgrounds.

Accurately defining a woman’s tumor and its risk of reoccurrence at the earliest stage possible in her breast cancer journey is critical to optimizing and personalizing treatment planning. Yet, the pathological processes and 21-gene genomic tests commonly used by health systems often do not account for the impact a woman’s race can have on the underlying biology of her tumor. Not only are Black women’s tumors often misclassified [2], but their risk is also underestimated over 60% of the time [3].

Agendia is committed to advancing the industry’s understanding of the racial disparities in the underlying biology of women’s tumors, as evidenced by this latest research. In a poster titled “Impact of race on BluePrint genomic subtyping in HER2+ breast cancer,” Agendia illustrates that race did not influence the biology underlying clinically-defined HER2+ tumors, with BluePrint reclassifying White women and Black women as Luminal, Basal, or HER2 in proportional numbers. This is a stark contrast to previous research on HR+HER2- tumors, which found Black women are twice as likely to have aggressive Basal-type tumors compared to White women [4].

“Every woman, regardless of her race, should have equal access to unbiased insights into her cancer, and a reliable view into what the future of her treatment holds. Yet, the inherent bias of today’s conventional genomic testing and reliance on oversimplified pathological insights fails, and even harms, many women of color,” said William Audeh, MD, Chief Medical Officer of Agendia. “At Agendia, we are leading the charge in changing the status quo of breast cancer care for those who have historically been marginalized in both cancer research and genomic assay development through practice-changing research.”

Agendia is also showcasing the impact of its FLEX trial to accelerate research for racial and ethnic groups that are typically underrepresented in clinical trials. Building on its milestone achievement of 10,000 enrolled patients announced at the 2022 annual meeting, the FLEX trial now includes the genomic and clinical data of over 13,000 women, including over 1,000 Black women. This makes FLEX the largest prospective cohort of Black women with whole genome and clinical data. Expanding the power of genomic insights ultimately helps inform personalized, biology-based care for these women and overcome enduring racial disparities in breast cancer care.

Agendia will also present a poster on MammaPrint’s ability to predict chemotherapy response in women with high-risk early-stage breast cancer, and an oral presentation on the ability of genomic biomarkers to predict a woman’s response to immunotherapy. Agendia will be sharing updates throughout the conference on its Twitter, Facebook and LinkedIn pages.

About Agendia

Agendia is a mission-driven, commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide. The company currently offers two commercially-available genomic profiling tests that help surgeons, oncologists and pathologists to personalize treatment for women at critical intervention points throughout their patient journey.

MammaPrint^® is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patient’s breast cancer recurrence risk. BluePrint^® is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior. Together, MammaPrint^® and BluePrint^® provide a holistic view of the biology underlying an individual patient’s breast cancer, enabling physicians to objectively select the best treatment plan.

For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com.

[1] Reid, S., et al. (2022). Whole transcriptomic analysis of HR+ breast cancer in Black women classified as basal-type by BluePrint. Journal of Clinical Oncology, 40(16, Suppl.), 517-517. https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.517

[2] Reid, S., et al. (2021). MammaPrint and BluePrint identify genomic differences in HR+ HER2- breast cancers from young Black and White women. Presented at SABCS 2021. https://agendia.com/wp-content/uploads/2021/12/SABCS_2021_poster_VUMC.pdf

[3] Robinson, P., et. al. (2021). Genomic risk classification by the 70-gene signature and 21-gene assay in African American, early-stage breast cancer patients. Journal of Clinical Oncology, 30(15, Suppl.). https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.e12568

[4] Reid, S., et al. (2022). Whole transcriptomic analysis of HR+ breast cancer in Black women classified as basal-type by BluePrint. Journal of Clinical Oncology, 40(16, Suppl.), 517-517. https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.517

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