A recent companion diagnostics deal that Agendia has penned with AstraZeneca and the Netherlands Cancer Institute could help the Dutch firm validate and expand its test menu, according to its CEO.
Bernhard Sixt said there are a "number of possible outcomes" from the collaboration, some of which may "benefit" ColoPrint, Agendia's in-development colorectal cancer diagnostic, as well as other tests in its pipeline.
For example, he said the alliance could help the firm discover a "tentative molecular subtype signature" for the ColoPrint test as well as other "potential novel gene signatures."
Agendia, based in Amsterdam, disclosed the AstraZeneca-NKI agreement earlier this month. Terms of the deal call for Agendia to "provide molecular data, bioinformatics support, and diagnostic expertise" to help AstraZeneca define colorectal cancer subpopulations, the partners said in a statement.
Ultimately, they aim to accelerate the development of targeted colorectal cancer drugs, though it is also possible that Agendia will develop commercial companion diagnostics for certain undisclosed drugs in AstraZeneca's pipeline.
Sixt said that as part of the partnership, Agendia will use a custom, whole-genome, gene-expression profiling array manufactured by Agilent Technologies for "discovery and commercial experiments."
He said that Agendia has already used the array in studies with pharmaceutical companies. One, called the MINDACT (Microarray in Node-negative Disease May Avoid Chemotherapy) trial, is a multi-center, prospective, phase III randomized study comparing Agendia's MammaPrint 70-gene-expression signature breast cancer- recurrence test with a common clinical-pathological prognostic tool to select patients with negative or 1-3 positive nodes for adjuvant chemotherapy in breast cancer. Novartis, Roche, and Sanofi-Aventis are all funding the MINDACT trial.
Another is the US National Cancer Institute-sponsored I-SPY II (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis) study, which is designed to predict therapeutic response in the neoadjuvant setting. Researchers in that trial are using Agendia's whole-genome microarray platform to develop oncologic therapies paired with biomarkers. Abbott, Amgen, Pfizer, J&J, Roche, and Eli Lilly are all participating in the trial.
According to Sixt, Agendia uses its expression-array platform in all of these projects, and data from the array can be used to design new tests. "In all of our collaborations with big pharma … we use full genome-expression data for all patients to develop a full database to mine for new companion diagnostics," he said.
The US Food and Drug Administration in 2007 cleared MammaPrint, Agendia's first expression signature test (BAN 2/13/2007). The assay is offered as a service from Agendia's labs in Amsterdam and Irvine, Calif., the latter of which opened last year (BAN 9/29/2009).
Following the launch of MammaPrint, Agendia in 2009 introduced TargetPrint, a gene-expression test that assesses a woman's level of estrogen and progesterone receptor and HER2/neu overexpression.
Last year the company launched two assays: BluePrint, a genetic test that classifies breast cancer into basal-type, luminal-type, and ERBB2-type (HER2/neu positive) molecular subclasses; and TheraPrint, a panel of 56 genes that the company believes can be used to diagnose disease and help predict response to a number of treatments.
TargetPrint, BluePrint, and TheraPrint are all sold as laboratory-developed tests. The firm markets them and MammaPrint as its Symphony Suite of breast cancer diagnostics.
Typically, Agendia processes MammaPrint directly for patients, whose oncologists can order the other tests based on initial results, according to the firm. More specifically, Agendia does not process distinct arrays in its testing services, but rather runs the same custom array, and performs different tests based on pre-identified gene signatures. Since the client's sample has already been run, the additional tests in the suite consist solely of reanalyzing the array data.
Sixt said that the AstraZeneca and NKI deal could therefore produce similar follow-on tests to Agendia's ColoPrint diagnostic. He noted that the company is also getting closer to pursuing US regulatory clearance for its ColoPrint test, designed to predict the risk of distant recurrence of stage II and III colon cancer patients. He declined to provide a timeline for when it might become commercially available to US clinicians.
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So far, Agendia has finished independently validating ColoPrint and is further validating the chip's production process, he said. When done, it will file for FDA clearance.
"Timelines are difficult to project, but speaking about our experience from the past clearances around MammaPrint, it was within a couple of months," he said.
The Advantage of Arrays
In the breast cancer-testing arena, Agendia's main competitor has been Genomic Health's RT-PCR-based Oncotype Dx breast cancer-recurrence test. The company also launched an Oncotype DX test for colon cancer last year and is planning to release an Oncotype DX test for prostate cancer in 2013.
Though RT-PCR is thought of as being less expensive than arrays as a platform on which to run a test, Sixt said Agendia's technology is a "big advantage" in the molecular diagnostics market.
"As our commercial microarray contains all of our clinical tests, we need only one analysis to create all raw data for all products," he said. "That means that after the first test — for example, TargetPrint — is done, the whole Symphony Suite is available on demand for that specific patient who had the TargetPrint [test]."
"Practically speaking, when the tumor board meets to make the chemotherapy decision they have two choices: either pick up the phone and get an unambiguous answer about recurrence risk from Agendia, or send a sample to a laboratory, wait for two weeks-plus, and still maybe get an intermediate result," he said.
While the company believes its technology has an advantage in the marketplace, it is also keen to build its sales and marketing efforts for it. In January, Agendia said that it is planning to file an initial public offering later this year to raise funds to help it validate and sell its tests. Sixt did not reply to a follow-up e-mail regarding the status of the IPO.
Additionally, in order to expand its sales and marketing efforts, the company last month added three members to its executive team: David Macdonald was named chief operating officer, Mark Willig was tapped as executive vice president of North American sales, and Doug Bradley was appointed vice president of global marketing (BAN 3/15/2011).
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