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Celera Diagnostics Begins to Find its Place Within Applera

NEW YORK, July 24 – As part of Applera’s $75 million program to transform itself into a drug discovery and diagnostics powerhouse, company executives for the first time Tuesday discussed in detail how Celera Diagnostics, the newest member of the Applera family, would distinguish itself from its more well-known brethren, Celera Genomics and Applied Biosystems (ABI).

While Celera Genomics and ABI focus on drug discovery and tools for genomics research, respectively, Celera Diagnostics will begin building an industrial-scale genotyping facility in Alameda, Calif.--across the San Francisco Bay from ABI--to identify gene and protein markers for disease.

The diagnostics arm of Applera hasn’t decided which specific diseases to target, but the company hopes to both expand the size of the market for molecular diagnostics, which Celera Diagnostics director Kathy Ordoñez estimated to be $1 billion, as well as take business away from current players in the diagnostics sector. Celera Diagnostics also hopes to target the market for protein chemistry, or immunochemistry diagnostics, by drawing on the proteomics efforts at Celera Genomics.

“We obviously believe that there are significant opportunities for many new diagnostics, including tests that will predict predisposition or monitor disease progress, look at disease severity, and predict response to therapy,” said Ordoñez in a conference call Tuesday morning. “We’re putting all these potential options into the equation and we’ll be making our selection of the first four to six diseases where we’ll focus over the coming months."

Celera Diagnostics first came into being last November, while Applera was still known as PE. At the time, CEO Tony White said the company would spend $20 million to $30 million a year to develop DNA-based assays for detecting patients’ susceptibility or progress in fighting certain diseases. To head the new company, Applera hired Ordoñez, the former CEO of Roche Molecular Systems, and two other senior executives who had worked with her.

Now, the company has grown to about one hundred scientists and business executives, Ordoñez said, and is converting two buildings in Alameda, with a combined 66,000 square feet of space, into a genotyping facility filled with ABI systems for detecting SNPs and performing gene expression studies. Ordoñez expects the facility to be up and running sometime in October.

Celera Diagnostics will also work in tandem with Celera Genomics, Craig Venter’s arm of Applera. As part of the $75 million Applera initiative, Celera Genomics will sequence the genomes of an additional 40 to 50 individuals to find new disease-related SNPs and haplotypes, or neighborhoods of SNPs. If these SNPs — or proteins from Celera’s proteomics efforts — have potential as diagnostics, Ordoñez’s company will attempt to turn these discoveries into products.

“The discovery work will be done at Celera [Genomics], and then we‘ll be taking the fruits of those efforts into Celera Diagnostics, [and] validating and commercializing them,” Ordoñez said.

But Ordoñez and White said the diagnostics company has yet to decide which platform the company would use to perform its genotyping studies. Over the next couple months, Ordoñez said, the company also hopes to develop partnerships with academic medical institutions or other providers of clinical samples. In addition, White said that he had not ruled out having Celera Diagnostics partner with a major diagnostics company, rather than go it alone.

“This is really the pre-party for diagnostics, as my daughter in college calls it," White said, "because there’s a lot of pieces in our diagnostics strategy that we have not completed our analysis on and are not ready to go public on. We will over the next couple of months be in a position to give a much clearer picture of our vision for our diagnostic business and how we’re going to conduct ourselves.”

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