Agendia
Agendia is a molecular diagnostics company focused solely on breast cancer, offering the MammaPrint and BluePrint genomic tests for early-stage disease.
Last updated September 26, 2026
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Overview
Agendia is a molecular diagnostics company that describes itself as the only molecular diagnostics company focused solely on breast cancer. Based in Irvine, California, the company develops and commercializes genomic tests that go beyond traditional clinical factors to reveal the risk of breast cancer recurrence and the underlying tumor biology, with the goal of personalizing treatment decisions for patients with early-stage breast cancer. The company's core offering is a pair of complementary genomic tests: MammaPrint, a risk-of-recurrence test, and BluePrint, a molecular subtyping test. According to the company, the two tests together provide results in just six days, helping physicians determine the likelihood that a patient's breast cancer will recur and identify the genomic drivers of tumor growth. Agendia positions these tools as a way to match each patient to the right treatment at the right time and to help minimize both under-treatment and over-treatment. Agendia emphasizes the depth of its clinical evidence base. Its website cites more than 180 publications and abstracts, more than 23,000 patients enrolled in the FLEX Study, use of its tests in more than 45 countries, and recognition in seven guidelines. The company says its tests are trusted by leading physicians and institutions around the world, and it points to landmark studies validating the utility of MammaPrint and BluePrint in early-stage breast cancer. Agendia's stated mission is to empower women with early-stage breast cancer and their care teams with personalized, biology-based insights that guide customized treatment plans. The company has launched a CE-marked test suite in Europe and is expanding access in Latin America and Asia. It works with academic institutions, cancer centers, and advocacy organizations, and participates in clinical trials including I-SPY2 and the FLEX Study. Mark R. Straley is identified as CEO.
History
Agendia is a molecular diagnostics company based in Irvine, California, dedicated to genomic testing for breast cancer. The company describes itself as the only molecular diagnostics company focused solely on breast cancer, and it has built its business around two complementary genomic tests: MammaPrint, a risk-of-recurrence test, and BluePrint, a molecular subtyping test. Agendia's clinical evidence base has grown over decades of research and real-world data. The company reports more than 180 publications and abstracts supporting its tests, and its FLEX Study has enrolled more than 23,000 patients, later surpassing 25,000 patients according to a company press release. Its tests are used in more than 45 countries and are recognized in seven guidelines. Landmark studies have provided data on the validation and utility of MammaPrint and BluePrint for patients with early-stage breast cancer. The company has expanded internationally, launching a CE-marked test suite in Europe and reaching into Latin America and Asia. It has also achieved reimbursement milestones, including definitive, mandatory Swiss health insurance reimbursement for MammaPrint genomic profiling. Agendia collaborates with leading academic institutions, cancer centers, and advocacy organizations, and participates in clinical trials such as I-SPY2 and the FLEX Study. Mark R. Straley serves as CEO, and the company's mission is to empower women with early-stage breast cancer and their care teams with personalized, biology-based insights.
FLEX Study surpasses 25,000 patients enrolled
Agendia announces definitive, mandatory Swiss health insurance reimbursement for MammaPrint genomic profiling
CE-marked test suite launched in Europe
Products and positioning
A global leader in innovative genomic technology and diagnostic tests, dedicated to pristine science in personalized medicine and focused solely on breast cancer.
MammaPrint
A risk of recurrence test that reveals the likelihood of a patient's breast cancer recurring.
BluePrint
A molecular subtyping test that determines the underlying genomics driving the growth of a tumor.
Recent events
Illumina and Agendia announce multi-year partnership[4]
Reported:
Illumina announced a multi-year partnership with Agendia to co-develop in vitro diagnostic tests for oncology testing, including plans to develop tests for breast cancer using Illumina’s MiSeqDx platform.
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