Next-generation sequencing version of MammaPrint and BluePrint enables decentralized testing in CE-mark jurisdictions like Germany

Analysis for Belgian Health Care Package shows MammaPrint yields cost-savings for breast cancer care systemically

Agendia, Inc., a 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, today announced that it will present new data at the European Society for Medical Oncology (ESMO) Breast Cancer Congress 2022 taking place in Berlin, Germany on May 3-5, 2022.

The first of the two poster presentations, entitled Equivalence of NGS-based MammaPrint 70-gene signature risk of recurrence and BluePrint 80-gene signature of molecular subtyping tests to the centralized microarray tests [234P], concludes that the next-generation sequencing (NGS) version of MammaPrint and BluePrint[1] is equivalent to the centralized microarray test, as demonstrated by results from various labs globally. This enables a more accurate decentralized solution to breast cancer care fostering worldwide accessibility to more reliable genomic testing.

“The accessibility of breast cancer care is crucial and by validating the interchangeability of the NGS version of MammaPrint and BluePrint compared to the standardized microarray tests, new doors are opened for global physicians who may need to rely on in-country platforms in order to secure the MammaPrint and BluePrint results their patients may require,” said Annuska Glas, Senior Vice President Research and Development and Innovation at Agendia. “MammaPrint is a valuable tool to support treatment planning for breast cancer patients and with the decentralized NGS platform, this can be offered in even more countries. These findings further confirm that MammaPrint and BluePrint can provide the same accurate results through NGS.”

Agendia is expanding novel ways to ensure accessibility of care worldwide by advancing solutions with a decentralized option for testing kits to run on an NGS platform, and innovative modalities such as digital AI pathology. This data presented at ESMO Breast follows an announcement from Agendia earlier this year that it is progressing its Digital MammaPrint artificial intelligence (AI)-powered platform in Brazil to potentially fundamentally change the way breast cancer is treated by providing essential information more quickly and elevating the capabilities of global physicians treating women with breast cancer in their local communities.

A second poster presentation, entitled Budget impact analysis for the Health Care Package by using MammaPrint in Belgium [238P], builds on earlier research from the landmark MINDACT trial and combines this with the results of the interim analysis of the pilot study performed in Belgium (unpublished data). The budget impact model shows that use of MammaPrint yields savings for breast cancer care in Belgium for the Belgian Health Care Package when compared to no gene expression profiling testing. According to the budget impact model, the use of MammaPrint in patients selected according to criteria of the pilot study leads to high savings. If gene expression profiling was performed for all clinical high risk patients, savings would even be higher.

By combining the cost of genomic testing with the savings made due to a net reduction in chemotherapy usage, the annual savings add up to more than €5,800,000, an average savings of €3,900 per patient, compared with standard clinical care of a patient with breast cancer in Belgium. MINDACT has produced previous multi-country health savings analyses, published in the European Journal of Cancer, showing that genomic testing is beneficial as it provides valuable insights that potentially allow patients to avoid the complexity of chemotherapy, passing down significant financial savings to them while also triggering significant cost savings for large health systems around the world.

“Drawing from the impact data used from the pilot study performed in Belgium, we are able to determine new insights that the use of MammaPrint could grant substantial cost savings to women who may not require chemotherapy and could ultimately alleviate some of the burden on Belgium’s health care system as a whole,” said Pino Cusumano, MD, Breast Surgeon, Centre Hospitalier Chrétien, Liège in Belgium. “Data has previously demonstrated that by de-escalating women with Low Risk cases from chemotherapy treatment, outcomes are still as good and women are able to follow a more personalized treatment plan. We believe these data demonstrate that the previous analysis holds for the state of breast cancer care in Belgium in 2022, and that the overall patient benefit extends beyond physical care into financial wellness too.”

Taken together, the two posters presented at ESMO Breast 2022 suggest that regardless of where the patient is located, she is able to receive the same high-quality results with the added benefit of cost-effective treatment planning.

“The studies presented at EMSO 2022 underpin our central efforts at Agendia to ensure our genomic tests are widely accessible and affordable, without compromising scientific integrity or decision-making, to bring the clarity women with breast cancer seek to guide their treatment planning,” said Bastiaan van der Baan, Chief Clinical and Business Development Officer at Agendia. “Through our steadfast commitment to enable global adoption of MammaPrint and BluePrint, we look forward to continuing studies such as these to grow evidence supporting our mission to serve women with breast cancer throughout their treatment journey.”

¹MammaPrint and BluePrint next-generation sequencing kits are not yet cleared for sale in the United States by the US Food and Drug Administration^; BluePrint has been CE-marked for use in Europe. BluePrint is also commercialized as a Laboratory Developed Test (LDT) and audited under CAP/CLIA in the United States.

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, long-term prognosis and potential response to systemic therapy. 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.

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