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Current company Agendia
Biotechnology · 224 employees · Founded 2003 · Irvine, California, United States
Agendia, a precision oncology company, helps physicians and patients make personalized treatment decisions in early-stage breast cancer. MammaPrint® (MP), 70-gene breast cancer recurrence assay, is the only FDA-cleared (microarray) risk of recurrence test and is CE marked (IVDR-certified). BluePrint®(BP), 80-gene molecular subtyping assay, evaluates the underlying biology of a tumor to determine growth drivers. MP+BP are commercially available genomic tests, supported by clinical, guideline, peer-reviewed, and real-world evidence. They can be ordered on core biopsies or surgical specimens.*
*FDA Intended Use: the test is performed for breast cancer patients with Stage I or Stage II disease with tumor size ≤5.0cm and lymph node negative. The MP FFPE result is indicated for use by physicians as a prognostic marker only, along with other clinicopathological factors. Coverage criteria for majority of US health plans include early-stage breast cancer, tumor size less than or equal to 5.0cm (≤5.0cm), up to 3 positive lymph nodes, independent of receptor status, as validated in the 6,693 patient MINDACT trial. IVDR-CE mark Intended Use: you are a female breast cancer patient with Stage I or Stage II disease who is lymph node negative or lymph node positive with up to 3 positive nodes and for patients with stage III disease. The MP FFPE result is indicated for use by physicians and should be interpreted with other clinico-pathological factors. BP was developed and its performance characteristics determined by Agendia. It has not been cleared or approved by the US FDA, which determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This test was performed at Agendia, Inc (05D10•••50), which is certified under CLIA as qualified to perform high-complexity clinical laboratory testing. It is CE-marked for use in Europe. Social media policy: agendia.com/legal-compliance