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Biotech Tracker News - Bringing Microarrays to the Clinic  
January 31, 2003 Yesterday, Affymetrix (NASDAQ: AFFX) and Roche (Swiss: ROG) announced a partnership that is an important step in bringing DNA microarrays into the realm of clinical diagnostics. Roche licensed Affymetrix’s “gene chip” technology for 18 years to develop clinical diagnostic tests for diverse indications. Affymetrix will receive $70 million now as well as royalties on product sales. 

DNA microarrays are well accepted as having the potential to revolutionize medical research and patient care. DNA microarrays can simultaneously measure the gene expression of thousands of genes in a given sample. Messenger RNA (mRNA) binds specifically to a tiny area on the microarray corresponding to its gene, and the amount of bound mRNA is measured. The resulting patterns of gene expression are a molecular “fingerprint” of the sample. 

These fingerprints can be associated with many diseases and conditions, and can be used to more precisely evaluate molecular aspects of disease states compared to standard tests. For example, groundbreaking work has shown that cancers can be classified using a gene expression fingerprint derived from microarray analysis. By more accurately classifying cancers at the molecular level, doctors are able to match medicines to individual patients, and are able to identify aggressive tumors at an earlier stage. 

The clinical application of this technology is in its infancy. Current use of microarrays represents the tip of a large iceberg of clinical and commercial opportunity. Translation of DNA microarray analyses from the lab to clinical practice has been slow. Experiments often yield vast amounts of data, but are difficult to interpret in a clinically meaningful way. 

Hopefully, the Affymetrix / Roche alliance suggests a new emphasis on developing DNA microarray technology in a way that it will be useful in the clinic. It is not clear if Roche will maintain a testing facility that will process samples, or if it plans to develop an all-in-one machine that could process and amplify samples, load them onto microarrays, and analyze data right in the clinic.

We estimate that the market for microarrays in the clinic will exceed $1 billion by 2007. In 2000 and early 2001, Affymetrix was facing competition for microarray manufacturing from large companies like Motorola, Corning, Agilent, and IBM. While Agilent remains committed, Motorola and others have not followed through in this area. We expect that progress by Roche and Affymetrix would re-ignite the interest of these larger companies. However, Roche may be able to advance the diagnostic aspect of the microarray platform enough to maintain an edge over competition. Roche’s largest challenges will be to make microarrays easy to use, and to make the data generated from them easy to interpret. 
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