CEO SUMMARY: Having opened its CLIA-licensed laboratory in Huntington Beach, California, Agendia, Inc., becomes the newest competitor to enter the market for breast cancer testing. Its proprietary assay looks at 70 genes to assess the risk of recurrence. The company expects to collaborate with local pathologists, as its test requires fresh tissue and can provide a diagnostic answer for untreated patients, including both ER-positive and ER-negative patients. Agendia executives are pursuing Medicare coverage for the assay.
THERE ARE TWO ONGOING TRENDS in the highly-competitive market for breast cancer testing. First, new laboratory testing companies continue crowding into the market to compete for cases. Second, there’s a biomarker explosion underway, as a number of new assays for breast cancer utilize multiple biomarkers or genes to accomplish the analysis.
Both trends are illustrated by Agendia Inc., of Huntington Beach, California. In May, Agendia opened its CLIA-approved clinical genomics laboratory and began selling its services to pathologists nationally. Its primary new assay is MammaPrint. As a tumor gene expression profile test, it evaluates 70 genes that the company says helps physicians design tailored cancer therapy programs for the individual breast cancer patient.
Involve Local Pathologists
For pathologists, one notable aspect of Agendia’s business plan is that it wants to collaborate with local pathologists. “Agendia does not do ER/PR (estrogen receptor/progesterone receptor) or HER/2 testing. That’s the role pathologists play,” stated Daniel Forche, Vice President of Sales and Marketing at Agendia. “Rather, the molecular information provided by our MammaPrint assay supplements diagnostic data that pathologists already have. Given this scenario, we believe pathologists will be at the center of this work because molecular pathology is becoming more and more prevalent in healthcare.
“MammaPrint is a 70-gene test that identifies each patient’s chance for recurrence” Forche said. “The FDA cleared MammaPrint, an in vitro diagnostic multivariate index assay (IVDMIA), in February 2007. The results of this test place women in either a high-risk or a low-risk group for breast cancer to recur within 10 years. When the information from our test is combined with the information coming from the pathologist, it improves the ability of the oncologist to select the best therapy for their patients.
“Our assays work in a way that enhances the role of local pathologists,” explained Forche. “Our research determined that at least 231 genes seem to be prognostic in nature for breast cancer. We use 70 of the most critical genes to get a high-and low-risk result for breast cancer. One feature of our test is that it can be used on both ER-positive and ER-negative patients. Other assays can only be used with ER-positive patients. That’s important, for the following reason.
No Intermediate Group
“Other breast cancer tests have a large intermediate result,” he continued. “About 40% to 50% of patients fall into this intermediate group. International guidelines released recently basically state that there is no clinical utility from intermediate results. When a patient gets our test and is reported to be in the low-risk group, that person has a 10% chance of recurrence of breast cancer for 10 years. If physicians give those patients hormonal treatment, that risk drops to 5%.
“Another fact that sets our MammaPrint assay apart from others in the market is that it was developed for use with untreated breast cancer patients,” stated Forche. “That’s one main differentiator between our product and others.”
Attractive Market Segment
The recent entry of Agendia into an already crowded market for breast cancer testing demonstrates that breast cancer testing continues to be an attractive market segment for researchers and investors alike. Moreover, the development pipeline is full of additional new biomarkers and lab tests for breast cancer. As these new tests are launched, they will create new capabilities for pathologists and the clinicians they serve.
The Agendia business model also illustrates how new opportunities will open up for pathologists. Once a local pathology group has done ER/PR testing on the patient, if it is clinically relevant for an individual patient, the pathologists can refer fresh tissue (fixed with a molecular fixative) to Agendia. Agendia will perform the MammaPrint assay and deliver back the diagnostic answer that can help the oncologist and patient make more precise decisions about therapeutic options.
Further, the regular introduction of new, multi-marker genetic and molecular assays for breast cancer demonstrates how rapidly clinical practice is changing in this field. Diagnostic assays like these are the essential steps on the path to personalized medicine and companion diagnostics. They are a reminder that the profession of anatomic pathology is transforming at a steady pace.
Seeking Medicare Coverage for the MammaPrint Test
AS PATHOLOGISTS KNOW, the key to success when offering genomic tests is getting Medicare reimbursement for these tests,” observed Daniel Forche, Vice President of Sales and Marketing at Agendia, Inc. “We are currently in talks with the Centers for Medicare and Medicaid Services (CMS).
“The Medicare program has been supportive of personalized medicine testing,” he added. “In the 1990s, Myriad Genetics, Inc. paved the way when it won Medicare approval for coverage of its BRACAnalysis test, which assesses a woman’s risk of developing breast or ovarian cancer based on an evaluation of the BRCA1 and BRCA2 genes.
“Next came Genomic Health, Inc., with its Oncotype DX assay for breast cancer,” stated Forche. “This was a different assay because it looked at tumor genomics. Again, the Medicare program agreed to cover this assay.
“Currently, we use the same codes that Genomic Health uses to bill third-party payers for the MammaPrint test,” he noted. “Our early talks with CMS have been promising. There is growing recognition that personalized medicine is advanced by genetic diagnostic assays like these.”