COMPANY:

Agendia

"Agendia, Inc...today announced the publication of new findings in JNCI Cancer Spectrum validating the predictive utility of the MammaPrint 70-gene assay for chemotherapy benefit in patients with hormone receptor-positive, HER2-negative (HR+HER2-) early-stage breast cancer. The peer-reviewed article, titled “MammaPrint Predicts Chemotherapy Benefit in HR+HER2- Early Breast Cancer: FLEX Registry Real-World Data“, highlights how the MammaPrint Index predicts benefit from chemotherapy using a real-world, prospective, observational dataset."

"Agendia®, Inc...today announced the presentation of four major abstracts in collaboration with independent investigators at the 2025 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 29th– June 3rd, 2025, in Chicago, Illinois. "

P=Obs | N=3,0000 | FLEX (NCT03053193) | Sponsor: Agendia | "Agendia, Inc., today announced that new data from its ongoing FLEX Study will be presented at the upcoming ESMO Breast Cancer 2025 congress taking place May 14-17 in both Munich, Germany and virtually....The analysis found that patients with MammaPrint High Risk, HR+ HER2- Basal-type tumors were more likely to achieve a pCR following neoadjuvant chemotherapy compared to those with Luminal B tumors. The analysis also showed that these Basal-type tumors were more frequently recommended for chemotherapy overall, more often treated with neoadjuvant chemotherapy specifically, and received more intensive regimens compared to Luminal B tumors."

"Agendia®, Inc., announced today that new MammaPrint and BluePrint data and their ability to inform axillary surgery decisions in the neoadjuvant setting will be presented at the 26th American Society of Breast Surgeons Annual Meeting (ASBrS), taking place in Las Vegas, NV, April 30 – May 4, 2025. "

"Agendia®, Inc., today announced it will be presenting new data highlighting MammaPrint® and BluePrint® utility in guiding treatment decisions for patients with early-stage breast cancer. The findings will be presented in two spotlight presentations and two posters at the San Antonio Breast Cancer Symposium 2024 (SABCS), on Wednesday, December 11th and Thursday, December 12th."

"Agendia®, Inc. today announced the publication of a pivotal secondary analysis from the IDEAL randomized Phase 3 clinical trial in JAMA Network Open. The study highlights the ability of the MammaPrint (MP) genomic assay to predict benefit of extended endocrine therapy (EET) in post-menopausal patients with early-stage, hormone receptor positive (HR+) breast cancer."

"Agendia, Inc. today announced that a diverse patient population of over 17,000 has been successfully enrolled in the FLEX Study, a prospective real-world evidence, whole transcriptome, observational breast cancer study (NCT03053193). The FLEX Study, which intends to enroll 30,000 patients, employs a patient-centric design to accelerate impactful data generation through a national network of participating sites."

"Agendia, Inc. today announced that it has obtained certification from the European Union (EU) In Vitro Diagnostic Medical Device Regulation (IVDR) for three products, including its MammaPrint FFPE Microarray, BluePrint FFPE Microarray, and MammaPrint and BluePrint NGS Kit. These products are classified as Class C under this regulation."

P3 | N=3966 | "Agendia, Inc. today announced that the NSABP B-42 study evaluating the MammaPrint assay in predicting the benefit of extended endocrine therapy (EET) in early-stage breast cancer patients was published in the July issue of Journal of Clinical Oncology.... The data revealed that only MammaPrint Low (non-UltraLow) Risk tumors showed a statistically significant 10-year EET benefit of 9.5% for disease-free survival (DFS) and 7.9% for breast cancer-free interval (BCFI). Conversely, MammaPrint UltraLow and High Risk tumors did not derive statistically significant EET benefit."

P=Obs | N=2, 5000 | FLEX (NCT03053193) | Sponsor: Agendia | "Agendia, Inc. today announced it will present new data characterizing the immune biology of MammaPrint High Risk tumors in an oral session at the 2024 Annual American Society of Clinical Oncology (ASCO) Meeting, taking place in Chicago, IL. on June 3rd, 2024....Results of the analysis showed that MP High-2 tumors had a significantly higher frequency of antigen presenting cells (APCs) (including activated dendritic cells and macrophages, CD4+ memory T cells, CD8+ T cells, memory B cells and antibody producing plasma cells) relative to High-1 tumors, highlighting an increased immune active state in High-2 tumors. The increased antigen presentation and presence of APCs, which are critical in activating T- and B-cells, may explain why High-2 tumors display improved response rates to immunotherapy."

"Additional data supporting MammaPrint utility in treatment selection will be presented by investigators from the ISPY2 trial in a poster...By using data from the ISPY-2 trial, this poster demonstrates that MammaPrint H2 tumors have molecular and clinical similarities to triple negative breast cancer tumors, underscoring critical insight into how treatment plans can be optimized to achieve the best result for the patient."

P=Obs | N=25,000 | FLEX (NCT03053193) | Sponsor: Agendia | "Agendia, Inc. today announced it will present new data on the 3-year outcome of patients with hormone receptor-positive (HR+), HER2-negative early-stage breast cancer when treated with two different chemotherapy regimens at the 2024 Annual American Society of Clinical Oncology (ASCO) Meeting, taking place in Chicago, IL. on May 31st, 2024....Results showed that patients with MammaPrint H1 Luminal B-Type tumors demonstrated similar 3-year outcomes when treated with either TC (97.1%) or AC-T (95.3%), suggesting that patients who are classified as H1 may be able to avoid the toxicity of an anthracycline. However, patients with MammaPrint H2 Luminal B-Type tumors demonstrated a significantly higher relapse-free survival when treated with AC-T (97.7%) than with TC alone (86.4%). These findings indicate that MammaPrint H2 tumors benefit from the addition of an anthracycline to their adjuvant chemotherapy regimen."