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Clinical recognition

The discovery of PCR by a team of scientists led by Dr Kary Mullis at the Cetus Corporation, in 1985, has been hailed as one of the most revolutionary tools of molecular biology. It resulted in Dr Mullis being awarded the Nobel Prize in Chemistry in 1993. Roche acquired the rights to PCR technology in 1991 and has made PCR (under the brand name AMPLICOR ) the leading amplification technology for RNA and DNA in the world. In particular, Roche has led the field in the adaptation of PCR techniques to the routine clinical laboratory setting, through the development of assays in kit form, as well as the development of hardware to automate the process. In the field of HIV, these advances have facilitated rapid and accurate determination of viral load, minimising the potential for human error and maximising throughput and sensitivity.

A number of pivotal clinical trials of new therapies for HIV employed AMPLICOR products as the preferred system for therapy evaluation. These trials included:

  • ACTG 175 (and other ACTG trials)
  • DELTA
  • CHEESE
  • INCAS
  • SPICE
  • MACS

The AMPLICOR HIV-1 MONITOR Test is now one of the most commonly available viral load testing systems in the world and was the first test to be approved by the FDA for quantitation of HIV-1 RNA in human plasma. This background has lead to the adoption of The AMPLICOR HIV-1 MONITOR Test as the gold standard in viral load testing.

 

 

 

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