With due caution, Agilent Technologies entered the diagnostics arena for microarrays in August, clearly heeding the warning signals raised by Roche’s entry in the US marketplace in June.
Agilent made its move by announcing a collaboration with Netherlands Cancer Institute spinoff Agendia. Agilent said it will supply microarrays for Agendia’s planned clinical research on breast cancer with the goal of validating the technology for potential diagnostic applications. The two firms, Agilent said in a statement, will work toward developing a microarray-based diagnostic test to predict the aggressiveness of breast cancer tumors based on the activity of key genes.
Agendia is a new company created by researchers from the Netherlands Cancer Institute to further their research on breast cancer. Late last year, the researchers, Marc van de Vijver and Laura van ‘T Veer, co-authored papers published in the New England Journal of Medicine and Nature that presented their findings of a correlation between gene-expression signature patterns and breast cancer based on microarray research conducted on Agilent’s 60-mer oligonucleotide microarray platform.
Agilent, the No. 2 mass manufacturer of microarray technology — a market that, at best estimate, will reach $800 million this year alone — takes a step toward the in vitro diagnostics market, which analysts estimate at $22 billion and growing at 5 to 6 percent per year. The molecular diagnostic testing market, to be sure, is a smaller segment, but one whose growth is fueled by the constant addition of knowledge of new genes and mutations associated with clinical conditions.
Roche made its entrance into the microarray marketplace with a June press release launching its Affymetrix-built AmpliChip platform, to which the FDA responded with a letter requesting that Roche executives meet with it to discuss the propriety of marketing of a microarray-based device as a potential diagnostic.
This atmosphere has perhaps prompted Agilent and Agendia to step forward, with caution.
“Agilent is not a diagnostics company — they are FDA regulated — so it wouldn’t be appropriate for us to market a diagnostic product,” Christina Maehr, an Agilent spokeswoman told BioArray News. “Agilent is supplying the technology for this with regards to insuring the reproducibility and accuracy of the testing. We are looking to support the needs of researchers working in the clinical and diagnostic marketplace, but Agilent doesn’t have plans or intentions of becoming a diagnostics company ourselves.”
Representatives of Amsterdam-based Agendia were not available for comment before the publishing deadline.
According to published reports, Agendia is hoping to begin clinical trials in 2004, doing three studies involving some 5,000 patients.
For Agilent, that represents “a lot of arrays,” said Maehr.
Agilent, which debuted its first microarray product in 2001 and unveiled its 60-mer microarrays in October, is now shipping more than 20,000 microarrays per quarter and is seeing double-digit growth in its catalogue microarray business in each of the last three quarters, Maehr said.
The announcement of the collaboration between the two follows the July announcement detailing Agilent’s decision to create a whole-human-genome single microarray product, setting off a race with microarray newcomer Applied Biosystems to create, and sell, the first such mass-produced microarray product by the end of the year.
“When you are doing as much development in gene expression and microarrays, you are going to see such regular announcements,” said Maehr. “We are just building our business in gene expression.”