Roche Diagnostics

Research and Development

Innovation

Roche Diagnostics - researching and developing the best technologies

Molecular biology is the foundation of today’s revolution in genomics and gene therapy which is shaping how we live - from the way we treat and diagnose disease to how we prepare our food.

The Polymerase Chain Reaction (PCR) was a major breakthrough in this challenging area. Roche Diagnostics has led the PCR technology field throughout the 1990s and is the leader in systems for advanced PCR and reverse transcription (RT-PCR) for rapid on-line measurement of nucleic acid targets, mutation detection and sequence confirmation.

Bringing PCR to life.......

PCR technology is a Nobel-prize winning discovery. It is a chemical process that enables low concentrations of DNA from target organisms to be copied and detected with high specificity. It is a simple yet elegant means by which virtually unlimited copies of genetic material can be made in a test tube. The technology was conceived by Dr Kary Mullis and a team of scientists from the Cetus Corporation, who first published their work in Science in 1985.

The discovery of PCR has been hailed as one of the most revolutionary tools of molecular biology and resulted in Dr Mullis being awarded the 1993 Nobel Prize in Chemistry. PCR has literally changed the way we think of, and use, genetic material.

Since acquiring the rights to this technology in 1991, Roche Diagnostics has made PCR, under the brand name AMPLICORâ , the leading Nucleic Acid Amplification technology products in the world. Roche Diagnostics has developed and refined AMPLICORâ products to meet a wide range of applications.

Roche is also committed to other areas including molecular biology, cell biology and immunology, biomedicals and industrial biochemicals; launching over 100 innovative products each year.

Where to now? New research and developments

Roche Diagnostics is committed to developing PCR technology further through the progression of new tests and instrumentation.

From a clinical perspective, PCR’s exquisite sensitivity makes it possible to diagnose infectious agents earlier and to track disease progression and response to therapy. New applications of the PCR technique will facilitate improved disease detection, prediction of disease predisposition, assistance in treatment decisions and individualisation of patient therapy - resulting in earlier treatment and improved patient management and care.

From a laboratory perspective, new breakthroughs in PCR technology with AMPLICORâ PCR products save valuable time, minimise the risk of manual errors, alleviate the contamination risk and reduce the need for reagents and disposables. In particular, the introduction of the COBAS AmpliPrepä system will automate the preparation of specimens for investigation, enabling specimens to be made suitable for PCTC to be met in a more time-efficient way.

The new COBAS TaqMan™ system will feature a 5’ nuclease kinetic process with fluorescent energy transfer - which will enable signals to be detected during the amplification phase. This means that real-time detection is achieved, reducing time needed to run diagnostic tests.

All new tests based on this process will generate an even broader dynamic range than currently available with colourimetric tests - while maintaining unparalleled sensitivity.

Another example of the new developments is the AMPLICOR HIV-1 MONITORä Test with the UltraSensitive sample preparation method, which has recently been developed to provide a detection limit for HIV that extends even further than any previously developed test. The detection success has been evaluated in separate studies and is now accepted as a highly sensitive test for detecting plasma levels as low as 50 copies/mL, when previously 400 copies/mL was the standard limit. The measurement and tracking of HIV RNA is significant in advancing the effectiveness of evaluating anti-HIV therapy.