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Celera Diagnostics Submits Product for FDA Approval

NEW YORK, July 31 – Celera Diagnostics has sought marketing approval from the FDA for its HIV drug resistance system, the company announced Tuesday.

The premarket notification submission was made for Celera Diagnostics’ ViroSeq HIV-1 Genotyping System, an in vitro  method for detecting drug resistance in the HIV-1 virus genome.

“HIV-1 virus mutates rapidly, which greatly compromises the efficacy of drug regimens,” Eric Shulse, director of molecular diagnostics at Celera Diagnostics, said in a statement. “We believe that genotyping with the ViroSeq HIV-1 Genotyping System will be a useful tool in identifying drug resistance in the HIV-1 genome. With this information, physicians could in the future be able to prescribe treatment regimens that might be precisely tailored to the type of HIV-1 drug-resistant strain infecting the patient.”

Celera Diagnostics is a joint venture of Applied Biosystems Group and Celera Genomics Group, which are part of Applera Corporation.

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 Kathy 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. 

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