The Origin of Roche Molecular Diagnostics
The Roche Group created a new diagnostics business area with the December 1991 acquisition of the revolutionary polymerase chain reaction (PCR) technology from Cetus Corporation for $300 million. This new business area was formed as Roche Molecular Diagnostics (doing business in the U.S. as legal entity Roche Molecular Systems, Inc.). In a short period of time, Roche has made PCR a routine diagnostics tool and the leading DNA probe technology in the world.

PCR is a Nobel-prize winning technology and it is recognized as one of the most important scientific developments of our generation. More than 130 U.S. patents related to the PCR process are currently held by Roche based on these inventions that have now become routine tools to the field of molecular diagnostics. PCR allows scientists to copy a single segment of DNA billions of times, making it possible to take a specimen, such as a bacterium or virus containing genetic material weighing only one trillionth of a gram, copy its genetic sequence over and over, and, within hours, generate a test sample sufficient to confirm the presence or absence of a virus or bacteria, and to quantify the amount in blood.

PCR's ability to detect the virus or bacteria's nucleic acid rather than identify a less specific immunological antibody or antigen response makes it possible to diagnose many infectious diseases earlier in the infection cycle, as well as monitor disease progression and response to therapy.

Today, Roche develops PCR-based assays and platforms for clinical diagnostic and research use in the areas of blood screening, genomics, oncology and microbiology.

Making PCR Broadly Available Through Licensing Programs
Through Roche's broad-based licensing program, established immediately following the acquisition of PCR from Cetus, PCR-based products and services are now available worldwide for a wide variety of applications. This has enabled the technology to become recognized as the "gold standard" for molecular diagnostics.

Companies and health organizations have been licensed to use the original PCR patents, called the "foundational PCR patents," as well as newer real-time PCR patents, for which the company still holds a considerable amount of intellectual property.

PCR process to provide diagnostic testing for humans and veterinary purposes as well as agricultural, environmental, quality assurance, forensic, and food testing applications. Furthermore, Roche has licensed numerous companies to make and sell PCR products for research, food testing, forensics, agricultural and environmental testing, and for human and veterinary diagnostic testing. Roche also provides a licensing program enabling companies that manufacture DNA for ladders and arrays to use the PCR process in that business.

Roche Molecular Diagnostics is widely recognized for advances such as thermostable enzymes and the engineering of hot-start thermostable DNA Polymerases that reduced manual interventions and improves specificity and sensitivity of PCR and real-time PCR testing.

Ultimately, the company evolved PCR from a highly manual technology to one that combines ease-of-use automation with advances that enable sample in, results out real-time testing. Most RMD tests come with the added security feature of proprietary Roche-only AmpErase® enzyme, which, with a closed-tube format, virtually eliminates cross-contamination that can lead to inaccurate test results.

Ongoing Innovations
RMD continues to lead innovations that are enabling clinical insights into gene-based factors that can be used to enhance decision- making during the treatment process.

After successfully commercializing basic PCR for diagnostic and research applications, RMD continued its innovation of this amazing technology through development of real-time PCR, for which the company still holds many active patents. Now considered the state-of- the-art standard for molecular diagnostics, real-time PCR improved sensitivity, specificity and accuracy over earlier-generation PCR tests.

Using a closed-tube format, real-time PCR, together with AmpErase® enzyme prevents cross-contamination between samples being processed in tandem. With its wide dynamic range, a single real-time PCR assay can detect and accurately quantify as little as a few virus particles up to millions. This capability has enabled important clinical advancements, such as the highly accurate viral load testing critical to proper assessment of disease progression and response to therapy for HIV and hepatitis.