Genotyping System to Become in Vitro Diagnostic

A genotyping system, used to determine the genetic composition of an organism, may soon be marketed as an in vitro diagnostic product, according to the developer, Celera Diagnostics, a joint venture of Applied Biosystems Group (Alameda, CA, USA) and Celera Genomics group (Rockville, MD, USA). Pending receipt of marketing clearance, Applied Biosystems will have marketing responsibility for the product.

The genotyping system, called ViroSeq HIV-1, is used by laboratories and clinicians as a method of resistance testing for HIV. The ViroSeq system sequences the strain of HIV-1 virus infecting a patient and is being submitted for approval as a potential diagnostic tool that could offer doctors information helpful in patient management. The system targets protease and reverse transcriptase genes in the HIV-virus that spontaneously develop drug-resistance mutations at a rapid rate.

"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,” said Eric D. Shulse, director, molecular diagnostics, Celera Diagnostics.




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