Agendia
Agendia is pioneering the development and commercialization of validated tests, which help healthcare professionals determine diagnosis, prognosis and therapeutic responsiveness of cancer in individual patients. At the core of Agendia’s business is the understanding that cancer is a genetic disease that therefore requires an understanding of each patient’s unique genetic makeup in order to develop targeted therapies that kill only cancer cells, while leaving surrounding healthy tissue intact. Unfortunately, that is not the case with the use of chemotherapy treatments today. Many patients are over- or undertreated, resulting in less effective care and inflated healthcare costs. Building on a cutting edge genomics platform for tumor gene expression profiling, the company’s tests aim to help physicians more accurately tailor cancer treatments. Since 2008, the company has successfully established a sales and marketing presence in the U.S., with headquarters in Irvine, CA, and Amsterdam, the Netherlands. Agendia is at the forefront of the personalized medicine revolution, striving to bring more effective, individualized treatments within the reach of patients and their physicians. Agendia offers a suite of breast cancer products, called Symphony, which includes MammaPrint®, TargetPrint®, BluePrint® and TheraPrint®, and underpins the company’s goals by providing decision support for personalized treatment protocols. TargetPrint objectively quantifies ER, PR and HER2 gene expression levels. MammaPrint, which is based on a 70-gene signature and developed from an unbiased genome-wide analysis, identifies tumors that have the potential to develop chemotherapy sensitive metastasis with 94% accuracy. The seminal studies validating MammaPrint have been published in Nature and the New England Journal of Medicine. MammaPrint is the first IVDMIA (In Vitro Diagnostic Multivariate Index Assay) to receive FDA clearance and remains the only FDA cleared IVDMIA for breast cancer metastasis prediction. Both BluePrint and TheraPrint aid in the development of targeted therapies. BluePrint further stratifies MammaPrint classes into different biological subgroups (basal, luminal and ERBB2), which react differently to specific therapies, while TheraPrint identifies the expression of 56 novel drug targets. ColoPrint, Agendia’s colon cancer prognostic test, represents the company’s first step toward expanding its franchise into the colon cancer market and builds upon the success of MammaPrint, which is now in widespread clinical use for breast cancer.
Agendia’s strategic alliance with the Netherlands’ Cancer Institute (NKI), Europe’s second largest early phase clinical trial center, provides critical access to one of the world’s largest frozen tumor tissue banks and enables the rapid discovery and validation of new genomic profiles. Agendia’s agreement with NKI also provides the option to license commercial rights to NKI’s entire gene profiling research. The company also participates in the MINDACT trial (Microarray for Node-negative Disease may Avoid Chemotherapy), an international clinical trial with 6,000 patients that began in early 2007 and will finalize patient inclusion in mid-2011. This international research consortium seeks to identify and validate specific drug response profiles to Xeloda®, (Roche), Femara® (Novartis), Taxotere® (Sanofi-Aventis), Herceptin® (Genentech) and Tamoxifen in Agendia’s DiscoverPrint® data base (a full genome analysis of all patients). Agendia will retain the rights to all diagnostic products that originate from the MINDACT trial. Agendia’s MammaPrint service is also pivotal in the prestigious U.S. I-SPY 2 trial, sponsored by the foundation of NIH (FNIH) and under the guidance of the FDA, which aims to accelerate the availability of new targeted breast cancer drugs for clinical patients. The study currently includes PARP-, IGFR-, Angiogenesis-inhibitors and an APO/TRAIL agonist, from Abbott, Pfizer, and Amgen; with 5 other drugs under consideration. Additionally, the company’s DiscoverPrint® service will enable the discovery of specific drug response profiles.
An increasing percentage of medical professionals are choosing to trust and rely upon genomic testing to customize their patients’ treatment and, in doing so, reduce the incidence of unnecessary, ineffective and costly procedures. As a result, Agendia’s comprehensive suite of breast cancer products uniquely positions the company for continued, rapid growth in the breast cancer space.
________________________________________
Projected Launch 2012: ColoPrint® Gene Expression Profile for Colon Cancer Recurrence
ColoPrint is a microarray-based gene expression profile for predicting the recurrence of stage II and III colon cancer patients. Currently in the final stage of development, the combination of this profile and selected clinical variables could prove even more powerful and accurate in identifying high risk patients for clinical management.
________________________________________
Projected Launch 2012: Tumor Cell Percentage Profile
The Tumor Cell Percentage profile is a microarray-based gene expression panel of 13 genes that verifies the exact percentage of tumor present within a biopsy sample. The panel provides a significant benefit when working with small as well as poorly differentiated tumors.
________________________________________
Launched 2010: BluePrint™ Molecular Subtyping Profile for Breast Cancer Intrinsic Subtypes
The BluePrint Molecular Subtyping Profile is an 80-gene expression profile for the classification of breast cancer tumors into Basal-type, Luminal-type and ERBB2-type subclasses. Research suggests that breast cancer patients with these molecular subtypes have different prognoses and may respond better to specific therapies.
________________________________________
Launched 2009: Bio-Repository Services
Agendia understands that each tumor sample contains vital information which not only serves the patient today, but also provides a foundation for future answers to medical questions. The NCI recommends that all bio-repositories use the RNALater or RNARetain® room temperature, molecular fixative to maintain the highest quality genomic information during transportation. Agendia offers cryogenic bio-repository tumor banking services for all samples taken either from a core needle or surgical biopsy.
________________________________________
Launched 2009: TheraPrintTM – 56 Novel Drug Targets (RUO)
TheraPrint is a microarray-based gene expression panel of 56 genes that have been identified as potential targets for prognosis and therapeutic response to a variety of therapies. Although these genes are still in a research phase, in the future they may hold the key to a greater level of personalized prognosis and therapy for breast cancer patients. Today, TheraPrint is offered as a research tool and for Research Use Only (RUO).
________________________________________
Launched 2008: TargetPrint® for Estrogen Receptor, Progesterone Receptor & HER2/neu Status
TargetPrint is a microarray-based gene expression assay which offers a quantitative assessment of the patient’s level of estrogen receptor (ER), progesterone receptor (PR) and HER2/neu gene within her breast cancer tumor.
________________________________________
Launched 2004: MammaPrint® Gene Expression Profile for Breast Cancer Recurrence
MammaPrint is the first and only FDA-cleared IVDMIA gene expression breast cancer assay. This unique 70-gene signature provides physicians with the unprecedented ability to identify which early-stage breast cancer patients are at risk of distant recurrence following surgery. MammaPrint interrogates the 70 critical genes that provide a definitive gene expression signature and stratifies patients into two distinct groups – low risk or high risk of distant recurrence. With MammaPrint, there are no intermediate results.
| Type: | NORMAL |
| Address: | Agendia BV, Science Park 406, 1098 XH Amsterdam, The Netherlands |
| Website: | http://www.agendia.com |
| Phone: | +31 (0)20 462 1500 |
| Fax: | +31 (0)6 123 50044 |
| Email: | customerservice@agendia.com |