Roche Diagnostics

Research and Development


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Clinical Recognition


Innovation Next

Roche has more than half a century of experience in biochemistry, pioneering its use in industrial applications and for advancement of medical science.

Roche Diagnostics is now the premier organisation in the diagnostics market following the merger of the two most experienced and innovative businesses in the diagnostic area - Boehringer Mannheim Group and the Roche Group.

Development of the PCR

The process of PCR technology development since 1983 has been exceptionally rapid and vastly innovative - much more so than science would normally progress


  • Invention of PCR technology
  • Isolation of HIV as the causative agent of AIDS


  • The first publication of PCR in Science by Cetus Corporation (R. Saiki1 , S. Scharf, F.Faloona, K. Mullis, G. Horn, H. Erlich, N. Arnheim)
  • PCR studies in HIV begin


The major achievement of the year was the development of enzymes able to survive the heating in the PCR cycle, so that only one enzyme was required to perform both PCR amplification and reverse transcription activities.

  • Thermostable Taq DNA Polymerase, enabling automation of PCR, is declared ‘Molecule of the Year’ by Science
  • Hoffmann-La Roche Inc. and Cetus Corporation agree to begin development of diagnostic applications for PCR


  • The first forensic PCR Kit is introduced for HLA DQA
  • Cetus scientists, H. Erlich and K. Mullis, receive the Biochemical Analysis Award from the German Society of Clinical Chemistry
  • Cetus scientists Gelfand and Stoffel2 named inventors of the year for purifying Taq DNA polymerase


  • Hoffmann La Roche Inc acquires the world-wide rights and patents to PCR technology from Cetus and establishes Roche Molecular Systems Inc., devoted exclusively to the development of the PCR
  • RT-PCR (reverse transcriptase PCR) is developed using a single thermostable enzyme, rTth DNA Polymerase, facilitating diagnostic tests for RNA viruses such as HIV


  • Roche Diagnostics introduces the AMPLICOR HIV-1 (for HIV) and AMPLICOR Test for Chlamydia Trachomatis infections as the first standardised PCR kits for clinical diagnostic use


  • The Nobel Prize in Chemistry is co-awarded to Kary Mullis, one of the scientists who conceived the concept of PCR
  • The Japan Prize is also awarded to Kary Mullis
  • Roche Diagnostics introduces the AMPLICOR HCV Test (for Hepatitis C) as the first standardised RNA PCR kit


  • Roche scientists continue contributions to the research community through development of "long PCR" amplifying up to 40,000 base pairs
  • "First standardised quantitative PCR kits...."
  • AMPLICOR HIV-1 MONITORš test used in accelerated trials of protease inhibitors


  • The COBAS AMPLICOR š Analyser, first fully automated system for routine diagnostic PCR, is introduced
  • First standardised quantitative PCR kits - AMPLICOR HIV-1 MONITORš and AMPLICOR HCV MONITORš are launched, expanding the range of Roche’s innovative portfolio in Diagnostics AMPLICOR HIV-1 MONITOR Test is approved by the FDA in the United States
  • AMPLICOR HIV-1 MONITOR™ test used in accelerated trials of protease inhibitors


  • The AMPLICOR Enterovirus Test is launched in Europe
  • The AMPLICOR M. tuberculosis and AMPLICOR HIV-1 MONITOR™ tests are launched in the USA
  • The AMPLICORHIV-1 Monitor™ Test is approved by the FDA in the United States


  • The COBAS AMPLICOR Analyser™ is launched in US
  • Viral load reduced to undetectable levels by new combination antiviral therapies and the AMPLICOR HIV-1 MONITORš test with UltraSensitive sample preparation method launched across Europe
  • AMPLICOR HBV MONITORand AMPLICORģ CMV is launched in Europe


  • The COBAS AMPLICOR MONITOR™ System is launched in Europe with HCV, CMV and HIV viral load testing
  • COBAS AMPLICOR C. trachomatis is FDA approved in the US

This is just the beginning of the power of PCR and how Roche Diagnostics continues to provide innovative diagnostic solutions in the prevention, identification, treatment, evaluation and monitoring of disease.

1 Currently Roche Molecular Systems Scientists
2 Currently Roche Molecular Systems Scientists


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