AstraZeneca, Agendia, and The Netherlands Cancer Institute have formed a partnership that ultimately aims to develop targeted therapies for specific subtypes of colorectal cancer. As part of the collaboration, molecular diagnostics firm Agendia will provide molecular data, bioinformatics support, and diagnostic capabilities to help AstraZeneca define subpopulations of colorectal cancer as the basis for the discovery and development of drugs targeted to disease subtypes. The firm says it has already identified distinct molecular subtypes in colorectal cancer that each respond differently to various therapies. “Along with our new partners, we aim to identify drivers of the oncogenic process in each of these subtypes," explains Rene Bernards, Agendia cofounder and professor of molecular carcinogenesis at The Netherlands Cancer Institute.
Agendia’s flagship MammaPrint assay for assessing breast cancer recurrence risk is the only IVD multivariate index assay that has been approved by FDA, Agendia notes. The 70-gene signature test has been developed to identify which early-stage breast cancer patients are at risk of distant recurrence following surgery, independent of estrogen receptor status and any prior treatment.
Developing drugs for subtypes of colorectal cancer will require the ability to determine disease subtype using companion diagnostics, Agendia points out. “A key feature of this collaboration is that personalized medicine diagnostics may be developed far earlier in the development of new drugs than has previously been possible,” states Bernhard Sixt, Agendia CEO. “Our collaboration marks a continued shift in how we think about companion diagnostics and how they will be developed in years to come.” Agendia’s is currently finalizing development of its microarray-based ColoPrint gene-expression profile for predicting the recurrence of stage II and III colon cancer patients.
The firm has launched a number of microarray-based profiling assays since the first release of MammaPrint in 2004. TargetPrint® provides a quantitative assessment of breast tumor levels of estrogen receptor, progesterone receptor, and HER2/neu gene. BluePrint® is an 80-gene expression profile for the classification of breast cancer tumors into basal-type, luminal-type, and ERBB2-type subclasses. An additional product, TheraPrint, is available for research use only, and comprises a gene expression panel of 56 genes identified as potential targets for prognosis and therapeutic response to a variety of therapies.
In February Agendia received its fifth MammaPrint-related FDA clearance. The new approval will allow the firm to carry out the assay on two additional Agilent Microarray scanners and two Agilent Bioanalyzers, which it says will expand laboratory capacity to handle the increasing number of MammaPrint, TargetPrint, and BluePrint test requests.
MammaPrint was previously defined by the FDA as a qualitative in vitro diagnostic test service, performed only in Agendia’s Irvine labs. The latest FDA clearance defines a new “intended use”, which will allow the test to be carried out in a central laboratory, Agendia notes. This means the firm will be able to perform the tests for the U.S. market at both its CLIA and CAP-accredited laboratories in Irvine and Amsterdam or at other future central labs.