NEW YORK (GenomeWeb) – Agendia is in the process of moving from a centralized testing model of offering tests via a service laboratory to a decentralized one of selling kits or working with local partners to reach customers.
The change will be felt most immediately in Europe, where the Dutch molecular diagnostics company recently secured a CE-IVD mark for its next-generation sequencing-based MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit.
Agendia also plans to follow a decentralized model in Asia, so that it can make its tests available to clients in countries that are prohibited by law from sending samples outside of their borders. The firm is also evaluating how to make its tests available as kits in the US, according to a company official.
"For larger labs, moving from a centralized model to a decentralized one provides a nice opportunity," said CCO Chris Barbazette. "Leveraging the existing infrastructure that they have, they can run this test in a local mode," he said. "If there are issues in a given country about sending samples outside of the country, that helps get around that problem."
Barbazette noted that decentralizing testing should also help customers gain reimbursement for the tests. "As governments start to reimburse for these types of genetic tests, they typically want to do it within their borders," Barbazette said. "Running it locally allows them to do that."
Barbazette joined Agendia last year after a decade at Affymetrix, where he led global commercial operations for the vendor prior to its acquisition by Thermo Fisher Scientific. He also previously managed the company's Americas and Asia Pacific businesses. In his new role at Agendia, which is headquartered in Amsterdam and maintains a US office in Irvine, California, he is keen to see the company not only expand within its current markets, but reach new ones, which will require decentralization of its test menu.
Agendia's flagship assay remains MammaPrint, a microarray-based assay that relies on a 70-gene expression profile score to gauge a patient's risk of breast cancer recurrence. MammaPrint is currently offered as a service via Agendia's labs in Amsterdam and Irvine. The test has been cleared for clinical use in Europe as well as the US, where growth has been "substantial," Barbazette said, particularly as more payors come on line. Last year, for instance, Blue Shield of California decided to start covering the test. As of January 2018, MammaPrint has also had its own current procedural terminology (CPT) code in the US.
In addition to MammaPrint, Agendia has introduced BluePrint, an 80-gene, array-based molecular subtyping test, which supports the classification of breast cancer into RNA-based functional molecular subtypes. The recently CE-IVD-marked MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit combines both tests into one product, and allows customers to run the assays using Illumina MiSeq instruments.
The ability to run Agendia's tests in house could give the firm an advantage in Europe, where the firm competes with offerings such as Genomic Health's Oncotype Dx and NanoString Technologies' Prosigna Breast Cancer Test. While Genomic Health currently offers Oncotype Dx as a service, NanoString's assay is offered to customers via partners in various countries.
Agendia is "under a lot of competition," said Patrick Neven, a gynecological oncologist at University Hospitals Leuven in Belgium, which served as a beta testing site for the NGS-based MammaPrint BluePrint kit. "There are a lot of gene-expression profiles [on the market] and they hope that NGS will make theirs more widely accessible to more hospitals and labs," Neven said.
Neven spoke favorably of his experience with Agendia, as a user of its services. "We get the results quite quickly and rely on these prognostic tests in about 10 percent of our patients; we continue to use immunohistochemistry for steroid and HER2 receptor expression but BluePrint is interesting as a predictive test," he said. "The advantage of using the kit is that we can now do it on-site and not rely on results from Amsterdam."
While Europe is still Agendia's home market, it makes up only about one-fifth of its total revenues, while sales in the US bring in the bulk of the firm's income, Barbazette said. Its unclear to what extent the recent CE-IVD kit clearance will change that dynamic for Agendia, but he noted that in addition to US market expansion, encouraging growth in Europe, as well as adjacent markets in the Middle East, remain the firm's main priorities. The attainment of regulatory clearance in Europe does bring with it another benefit, as some other countries often require a product be cleared for clinical use in its home market before it can be submitted for regulatory oversight.
That's the case with China, where Barbazette has experience in gaining Chinese Food and Drug Administration clearance for molecular tests in platforms from his days at Affymetrix.
"Having a CE-IVD allows us to go after the China FDA and then partner with labs in China to offer MammaPrint after we get China FDA clearance," said Barbazette. He said that China represents the "biggest opportunity" for Agendia in Asia, especially since it's a market where clinicians cannot export tissue samples.
Yet other countries in the region are also on Agendia's radar. Barbazette cited Singapore, Thailand, Malaysia, and Vietnam as opportunities, as well as India, Australia, Japan, and Korea.
"Agendia has not focused there [in Asia] much as of yet, but it definitely will," he said. "We see it as an untapped opportunity," he said. "The need for breast cancer testing in those markets is the same as it is in the US and Europe."
At the moment, Agendia is working on discussions regarding market entry strategy in some Asian countries, and might be able to announce some partnerships later this year, Barbazette said. He noted that Latin America is also an opportunity for Agendia, particularly Brazil, "a huge market" that would require local approval to run testing and to get coverage nationally.
"With any market for a diagnostic product, it's a combination of a need for a test, and [whether] the government reimburse it, if there is a significant private payor market that will pay for the test," said Barbazette.
The big question facing Agendia is how to make a similar decentralized model work in the US, where US Food and Drug Administration clearance remains the avenue to clinical market entry.
The FDA originally cleared MammaPrint in 2007. A clearance in 2008 enabled Agendia to run the test on a second scanner and move from a low-density microarray to a high-density array. In 2009, the FDA cleared the test so that it could be used to gauge recurrence risk for women across a broader age range. And in 2011, Agendia received clearance to run the test on two additional Agilent microarray scanners, two Agilent Bioanalyzers, and offer testing at an additional site.
In early 2015, Agendia received FDA clearance for a version of MammaPrint for use with formalin-fixed, paraffin-embedded tissue.
"There are reasons to decentralize in the US, and it is our plan to do that, but our strategy is still evolving as to how to do that," said Barbazette. "It's not a technical issue, but we want to be compliant with the regulatory landscape and reimbursement to make sure that we are getting paid and that we are not doing anything out of line from a regulatory standpoint," he said.
Should Agendia find a way to decentralize in the US, it could serve the major cancer centers and pathology labs that have equipment in house to run its tests. "It gives the customers the opportunity to control the sample," he said.
In the short term, though, he said that Agendia will focus on expanding coverage for its MammaPrint service in the US market, while it assesses the idea of collaborating with medical centers to decentralize.
"Market expansion in the US is our number one priority," said Barbazette. "Expanding in Europe is another priority," he said. "And the amount of opportunity in Asia can't be ignored."