Agendia has inked a deal with the newly formed Molecular Profiling Institute to be the sole US provider of Agendia’s MammaPrint, a prognostic breast cancer gene-expression microarray.
The test, which assesses breast-cancer recurrence risk, will be available to US patients beginning next month. MammaPrint collects expression data on 231 genes, 70 of which are used in prognosis projection and were previously defined, according to Agendia Chief Operating Officer Laura Van ‘t Veer. The assay is intended for use in patients younger than 55 who have tumors smaller than 5 centimeters and are lymph-node negative.
“The MammaPrint test is based on a previously published work in Nature and The New England Journal of Medicine,” Van ‘t Veer, told BioArray News. “It is a prognostic test for breast cancer, predicting outcome of disease, and predicting development of recurrences in lymph node-negative breast cancer patients. By using this test we can divide patients into a high-risk group and a low-risk group for occurrence” of metastases within 10 years.
The Dutch firm, which was formed in 2003 and earlier this year raised an undisclosed sum through a Series A round of financing, will offer the test throughout Europe on its own. It initially launched MammaPrint in February and offered the test to doctors worldwide through its website. Oncologists have been able to send in tumor samples using a shipping procedure devised by Agendia and have received results within 10 business days.
Agilent, the No. 2 player in the microarray industry, has been custom-making the arrays for Agendia for about a year, Van ‘t Veer said. The test requires an Agilent scanner to do the read-out, but Van ‘t Veer noted that scientists at MPI, as a spin-off from the Translational Genomics (TGen) Research Institute, “have years of experience using Agilent microarrays.”
The agreement with MPI is a fairly significant one for Agendia. Even though MPI will run the test, it will be offered by MPI partner AmeriPath, which has a network of pathologists that serve roughly 3.5 million patients.
MPI Chief Operating Officer Richard Love told BioArray News that estimates suggest that 70,000 to 80,000 patients in the US could ultimately benefit from the MammaPrint test. But, he cautioned, it remains to be seen whether it will be useful to that many patients.
Agendia “had done a robust study — one of the most comprehensive studies in breast cancer with a signature — and it clearly distinguishes between patients at risk for recurrence versus those who aren’t at risk,” Love said. It was “one of the best separations we had seen in the scientific literature,” which is why MPI decided to offer the test.
TGen and the International Genomics Consortium announced the formation of MPI last week. Unlike its parent organizations, MPI is a for-profit venture and was seeded through $1.35 million in funding.
In addition to Agendia’s test, MPI is offering patients who have failed therapy an Agilent microarray to look for drug targets. That test is part of MPI’s Target Now program, which offers patients the opportunity to have their cancer sampled, profiled, and assessed to determine if one or more drug targets can be identified in the tumor.
In addition to the 70 test genes, the arrays have more than 1,000 control probes for standardization. Each patient sample is tested in duplicate, and every fifth test runs a standardized control sample to assure consistent quality, company officials told BioArray News in an interview earlier this year (see BAN 5/19/2004).
The MammaPrint is Agendia’s first product to be commercialized. The firm has several more tests in the pipeline related to breast cancer, colon cancer, and melanoma, and it also is working on treatment-response profiles.
MammaPrint sells for €1,650 ($2,196) in Europe and will price similarly in US, Van ‘t Veer said. “In the Netherlands, it is already being used in a prospective study and there is a temporary reimbursement from the health insurance companies.” In the US, the reimbursement issue “still needs to be settled,” she said.
The firm will likely seek European and US regulatory approval of the MammaPrint as an in vitro diagnostic product “within the next couple of years,” according to Van ‘t Veer.
“Currently, we are working on the CE mark and the ISO certification,” but the firm has yet to file for these approvals, she noted.
Validation Results Presented
Agendia presented results from an international validation project on the MammaPrint assay last week at the San Antonio Breast Cancer Symposium. The study, which was conducted by the Transbig translational research network, confirmed earlier results that showed the test outperforms currently used standard diagnostic criteria in predicting future development of distant metastases — development of tumors in other parts of the body, according to Agendia.
“The MammaPrint test is now validated in a series of patients that were treated at six different hospitals — five in Europe and one in the US,” Van ‘t Veer said. “These were all breast cancer patients diagnosed with lymph node-negative disease, who did not receive any further treatment other than surgery for their primary breast cancer.”
Using the MammaPrint, the proportion of patients that had a low-risk score was 40 percent of the studied breast cancer population. According to Van ‘t Veer, current US guidelines as defined by NIH select only 5 percent of patients in the low-risk group, while the MammaPrint test can identify 40 percent.
“Since the low- and high-risk scores are used to define which patients should be eligible for adjuvant chemotherapy, by using this test we can reduce the number of adjuvant therapy patients from 95 [percent] to 60 percent, while maintaining the same score of outcome of disease,” Van ‘t Veer said.
“By confirming the outcome prediction on this external validation … this is now level three clinical evidence for the biomarker,” she said. “So, this means it can now be made available to breast cancer patients.”
The test will now be used in a prospective randomized trial that is being conducted in Europe, Van ‘t Veer added.