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Molecular DiagnosticsSince acquiring the rights to the Nobel-prize winning polymerase chain reaction (PCR) technology in December 1991, Roche Molecular Diagnostics has made PCR the leading nucleic acid amplification technology in the world. This simple yet elegant means by which virtually unlimited copies of an identical piece of genetic material can be replicated in a test tube has provided the basis for unprecedented advances in detecting, diagnosing and monitoring response to therapy for a variety of infectious and genetic-based diseases, including chronic and often life-threatening diseases such as HIV and hepatitis.
Roche Molecular Diagnostics is organized around the Life Cycle Management model, an organizational structure that establishes transparency and clear lines of accountability for products at all stages of their development and commercialization. Today, RMD has Life Cycle teams focused on detection of infectious disease agents on the automated Cobas AmpliPrep / Cobas TaqMan system, Blood Screening, Human Papillmavirus (HPV) and Chlamydia trachomatis (CT) and Neisseria gonorrhoease (NG), new generation high- and medium-throughput automation solutions, and Microbiology.
Since its inception, the Molecular Diagnostics business area has harnessed the power of PCR technology to develop and commercialize innovative in vitro diagnostic kits. The business area's continued commitment to ongoing innovation continues to revolutionize the overall PCR testing process. Roche innovations have resulting in development of real-time PCR, full automation, and the development of technologies that enable new types of testing, such as modifications of PCR that for accurate detection of longer regions of specific gene regions. The company was also the first to develop and commercialize high-density microarrays powered by Affymetrix technology for clinical diagnostic use.
Roche Molecular Diagnostics also continues to advance automation and sensitivity for its core virology assays, such as the automated COBAS® AmpliPrep/COBAS® TaqMan® instrument platform, with an initial menu of tests for the quantification of HIV-1, Hepatitis C and Hepatitis B in human blood.
These tests measure how much virus is in a patient's blood, a key indicator of disease progression, response to therapy, and possible drug resistance. The system offers the first available menu of real-time PCR-based tests on a fully automated platform (sample preparation, amplification and detection), an important milestone in increasing laboratory efficiency and enabling a broader range of laboratories to adopt this state-of-the-art technology.
New applications of PCR technology in clinical diagnostics may also help clinicians to better understand risk assessment for disease onset or progression, thereby enabling a more tailored approach to therapy selection and improved patient care.
In 2005 Roche celebrated the official opening of the world's largest PCR manufacturing facility, where both reagents and diagnostic test kits are manufactured and shipped to sites worldwide. Roche invested more than 155 million USD to build the new 285,000 square-foot facility at its Branchburg, New Jersey campus. This new facility will produce more than 130,000 kits per month. Kit volumes continue to grow approximately 20 percent annually due to both new products and increases in demand for existing products.
Key Products
- The AmpliChip CYP450 Test:
Analyzes variations in two genes that play a major role in the metabolism of many widely prescribed drugs-FDA cleared January 2005, CE-marked September 2004.
- COBAS® AmpliPrep/COBAS® TaqMan® HCV, HBV and HIV-1 Tests:
Approved in the European Union, these in vitro diagnostics (IVD) products are the first real-time PCR virology tests available on a fully automated instrument system. All three tests for the quantitation of HCV, HBV and HIV-1 viruses in human plasma are for use on Roche's COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or COBAS® TaqMan® 48 Analyzer for automated amplification and detection. CE-marked in March 2005.
- Blood Screening:
The cobas s 201 system is the only complete nucleic acid testing (NAT) solution able to meet both current and future needs of blood screening labs.
- Automated real time PCR Solutions:
Introducing the first fully automated, real-time PCR solutions for improved reliability and accuracy of HIV-1, HCV and HBV testing.
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