Agendia

Address: Agendia BV, Science Park 406, 1098 XH Amsterdam, The Netherlands

Tel: +31 (0)20 462 1500

Web: http://www.agendia.com/

Company description

Agendia is a commercial-stage molecular diagnostic company, focused on the discovery, development and commercialisation of innovative products to improve the quality of life for cancer patients by providing healthcare professionals with critical information to enable safe and effective personalised treatment. We are currently marketing our Symphony™ suite of four complementary breast cancer tests, of which two currently generate revenue, with a strong focus on the US market. We have discovered, validated and received FDA clearance for the use of clinically useful gene expression profiles for our lead test, MammaPrint®, through a combination of our own research and research collaborations and strategic alliances with academia. The current breast cancer treatment paradigm is expensive and has significant shortcomings as a result of relatively poor assessment of recurrence risk and over-use of chemotherapy. Our MammaPrint® test has shown a clinically validated ability to predict the risk of breast cancer recurrence in the first five years after diagnosis, which is the period in which chemotherapy produces most of its benefits to a patient. MammaPrint® thereby gives physicians a more accurate tool to separate ‘high’ risk from ‘low’ risk early stage breast cancer patients and better gauge the ‘high’ risk patients’ need for chemotherapy than is currently available.

We were founded in 2003 as a spin-off from the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital in Amsterdam, for the purposes of pursuing commercialisation of molecular diagnostics using DNA microarray technology for cancer diagnosis and drug development. In 2004 we launched the initial version of our MammaPrint® breast cancer recurrence test in Europe. In 2006, we subjected MammaPrint® to an international independent retrospective validation which led to the selection of MammaPrint® as the exclusive molecular diagnostic stratification tool for the MINDACT trial, featuring 6,000 patients at 109 institutions in nine European countries. In 2007, MammaPrint® became the first IVDMIA to obtain 510(k) clearance from the FDA, and after receipt of this regulatory clearance we made MammaPrint® commercially available in the United States in 2008. As market awareness of our products in the United States and Europe grew, we also began to market other elements of our Symphony™ suite of breast cancer tests, adding TargetPrint® in 2009 and also, in 2010, BluePrint™ and TheraPrint® as LDTs. A significant landmark in our commercial development was our inclusion in 2009 in a local coverage determination by the Medicare carrier in California which processes all of our Medicare reimbursement claims.

Products and services

Delivering Clinically Relevant Gene Expression Profiling for Physicians and their Cancer Patients

As an innovative molecular cancer diagnostics company, Agendia leverages its knowledge and expertise in the application of clinically useful gene expression profiling to facilitate diagnosis, prognosis and cancer therapeutics development. With a robust pipeline of new cancer profiles in development, Agendia continues to be a leader in personalized medicine.

Projected Launch 2010: 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 2010: 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.