COMPANY:

Agendia

"Agendia...announced the first patient has been enrolled in the PROOFS Registry trial....The PROOFS Registry trial intends to enroll 1,500 patients via 100 sites in Germany by January 2025."

"Agendia, Inc...announced the updated National Comprehensive Cancer Network^® (NCCN) Clinical Practice Guidelines in Oncology – Breast Cancer Version 1.2023, recognize Agendia’s MammaPrint UltraLow Risk result and its proven impact on patient care. This inclusion is particularly critical for women with early-stage breast cancer who receive an UltraLow Risk test result and can safely forgo toxic treatments yet maintain excellent chance of survival."

"Agendia, Inc...announced it will present late-breaking research at the 2022 San Antonio Breast Cancer Symposium (SABCS) that proves MammaPrint is the first FDA-cleared gene expression profiling test to predict an early-stage breast cancer patient’s benefit from extended endocrine therapy (EET). The study, which analyzed MammaPrint results of over 500 patients enrolled in the IDEAL trial, proved MammaPrint test results can effectively identify which post-menopausal, hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer patients will benefit from five years of EET."

"At the 2022 San Antonio Breast Cancer Symposium (SABCS), Agendia, Inc...will present data demonstrating its proprietary signatures fulfill a critical unmet need for precise, proactive treatment planning for premenopausal women with early-stage breast cancer...data suggests that many young women with early-stage breast cancer may safely avoid the toxicity of chemotherapy if treated appropriately with endocrine therapy."

"Agendia...received acceptance for all six abstract submissions that will help guide the future of personalized cancer care and will be presented at the 2022 San Antonio Breast Cancer Symposium (SABCS). These studies focus on the impact of MammaPrint and BluePrint test results, unveiling the underlying biology of a breast cancer patient’s unique tumor to help inform more personalized treatment decisions."

"Agendia, Inc...announced the first patient has enrolled in the LESS clinical trial, sponsored by Unicancer with the institutional support of Agendia. In an effort to improve outcomes while preserving quality of life for early breast cancer patients, the study is designed to safely discontinue adjuvant endocrine therapy after two years for tumors with a MammaPrint Ultra Low result in post-menopausal women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer."

"Agendia, Inc...announced it will present seven posters derived from the company’s FLEX Trial, the real-world, multicenter, prospective, observational breast cancer study at the American Society of Clinical Oncology Annual Meeting (ASCO) 2022."

"The goal was to migrate the I-SPY2 findings into a robust clinical-grade signature – a biomarker that had not previously existed in early stage breast cancer – to predict sensitivity to IO drugs that target PD-1/PDL-1, a cell pathway that, when overexpressed, allows many breast tumors to escape destruction by the immune system....Importantly, results showed that in the development phase, the gene-expression biomarker ImPrint met this task and had the potential to predict pathologic complete response (pCR) to PD-1/PDL-1 checkpoint inhibitors with high sensitivity and specificity, especially in ER+ breast cancer which represents a large population of women who may benefit."

"Agendia...announced 10,000 patients have been successfully enrolled in the FLEX Registry. Agendia’s unique FLEX Registry is a real-world, large-scale, prospective, observational breast cancer study (NCT03053193) intended to enable the discovery of novel genomic profiles to improve precision in the management of breast cancer....Six posters based on data from FLEX will be presented at ASCO 2022, one of which will be a poster discussion session."

"Agendia, Inc...announced it will present new data from ongoing clinical research evaluating its comprehensive genomic tests at the upcoming American Society of Clinical Oncology Annual Meeting (ASCO), taking place June 3-7, 2022 in Chicago, Illinois."

"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 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."

"Agendia, Inc...announced new data published in Genes, Chromosomes and Cancer (Genes) that show MammaPrint® and BluePrint® gene signatures represent and capture all of the original 10 hallmarks of cancer (HoCs), recognized as the biological capabilities acquired during the multi-step development of human cancer, as defined by Hanahan and Weinberg."

"Agendia, Inc...announced that it is offering early access to its Digital MammaPrint platform for patients with breast cancer in Brazil, expanding the company’s offerings in the country with the goal of bringing essential information from cancer testing to the larger global breast cancer community...Brazil is the first country to have samples analyzed by Digital MammaPrint, allowing physicians and their patients to benefit from genomic insights derived from a digitized image of a breast cancer tumor."

"Illumina, Inc...announced a multi-year partnership with Agendia N.V...The partnership is intended to advance the use of next-generation sequencing (NGS) for decentralized oncology testing and aligns with Illumina's approach to IVD partnerships in oncology...Illumina and Agendia plan to develop new tests to enhance the care and management of breast cancer patients, utilizing the Illumina MiSeq™Dx sequencing platform to expand the range of gene panels available for solid tumor analysis. We expect Agendia's flagship test, MammaPrint™, which is FDA-cleared and currently offered via Agendia's central laboratory, to be the first decentralized NGS-based breast cancer recurrence risk test cleared by the FDA."

"Agendia, Inc...announced that it will present a spotlight poster at the 2021 San Antonio Breast Cancer Symposium (SABCS 2021) which confirms the utility of BluePrint® in guiding neoadjuvant treatment decisions."

"Agendia, Inc...presented data from a research collaboration with Vanderbilt University Medical Center demonstrating the capability of MammaPrint® and BluePrint® to identify differences in recurrence risk and tumor classification amongst different racial groups at the 2021 San Antonio Breast Cancer Symposium (SABCS 2021)...The presentation, titled MammaPrint and BluePrint identify genomic differences in HR+ HER2- breast cancers from young Black and White women, highlights new data signaling that among young women (­<50 years of age) with localized hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, MammaPrint and BluePrint identified racial disparities in risk of recurrence and breast cancer subtype distribution not detected by existing clinical factors."

"Agendia, Inc...shared data demonstrating the ability of MammaPrint® and BluePrint® to predict patient outcomes following neoadjuvant chemotherapy (NAC) at the 2021 San Antonio Breast Cancer Symposium (SABCS 2021)."

P3, N=3966; NCT00382070; "Agendia…announced positive results from an analysis using its 70-gene MammaPrint® assay on samples from the NSABP B-42 trial. These results were reported as an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting…The abstract, titled ‘Utility of the 70-gene MammaPrint assay for prediction of benefit from extended letrozole therapy (ELT) in the NRG Oncology/NSABP B-42 trial’ and MammaPrint was the only test that predicted a 52% relative benefit reduction in BCFI events (7.9% absolute benefit) and a 36% relative benefit reduction in DFS events (9.5% absolute benefit) with ELT."

“Agendia…announced that new data from the first-of-its kind, national FLEX registry was debuted today at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting…FLEX allows for diverse groups of patients and their physicians to participate in a clinical trial even if they are not living near a major research center…At the virtual ASCO 2021 conference, Agendia and its research collaborators provided a general update on the currently enrolling FLEX trial in a poster titled ‘The FLEX real-world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer.”

"Inivata...today announced it has entered a commercialization agreement with Agendia, Inc...Under the terms of the agreement, Agendia will gain co-exclusive rights to distribute Inivata’s RaDaR® liquid biopsy assay for the detection of Minimal Residual Disease (MRD) and early detection of relapse in patients with breast cancer in North America and Europe, with the option of extending territories over time. It is expected that the RaDaR assay will be reimbursed and available to clinicians in the US during 2022."

"Agendia, Inc...announced new data from the prospective Neoadjuvant Breast Symphony Trial (NBRST) which demonstrate the predictive and prognostic abilities of MammaPrint® and BluePrint®, and underpin both assays’ pre-operative utility in pre-and post-menopausal patients. A poster highlighting these findings will be presented at the 38th Annual Miami Breast Cancer Conference...These data confirm that genomic tests, like MammaPrint and BluePrint, have a place in every breast cancer diagnosis."

"Agendia, Inc…and Paige…today announced a first of its kind strategic partnership that will redefine precision oncology. The partnership will enable co-development of treatment planning tools that integrate the cloud-based Paige Platform with genomic information from Agendia’s proprietary MammaPrint® and BluePrint® diagnostic tests for patients with breast cancer. These new products will enable faster access to predictive and prognostic information along the entire continuum of care, from diagnosis and early intervention to metastatic treatment planning."

"Agendia Inc...announced today that the Federal Joint Committee (G-BA) has approved MammaPrint® , Agendia’s 70-Gene Breast Cancer Recurrence Assay. The G-BA decision to reimburse will broaden access to all breast cancer patients in Germany."

"Agendia Inc…announced today the availability of local testing for its CE-marked MammaPrint® BluePrint® Breast Cancer Recurrence and Molecular Subtyping tests, provided by PathoNext lab in Leipzig, Germany...PathoNext in Germany will partner with Agendia to run the tests and co-partner with HiSS, Agendia’s distributor in Germany. PathoNext will leverage its existing infrastructure to run MammaPrint and BluePrint in its own labs, using NGS instruments to analyze patient samples. HiSS covers a broad range of specialties, including oncology and cell biology."

"Agendia, Inc…today announced the presentation of four studies at the 12th European Breast Cancer Conference (EBCC-12). The data include a poster on further stratification of subtyping with BluePrint in breast cancer, as well as oral presentations that focus on the MINDACT trial, with a general trial update and in-depth analyses on screen- versus interval-detected breast cancers and the use of MammaPrint to evaluate lobular cancers."

"Agendia, Inc…today presented data at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 showing that MammaPrint’s Ultra-Low risk threshold can identify postmenopausal breast cancer patients who will have an excellent prognosis with limited or no tamoxifen treatment…‘These data are particularly exciting because they continue to demonstrate utility for MammaPrint in the clinically low risk patient population. The study suggests that we may be able to de-escalate endocrine treatment for these patients.’"