Genotyping System to Become in Vitro Diagnostic

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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