Diagnostics Portfolio

Roche’s Diagnostics Division is a leading supplier of in vitro diagnostics (IVDs): products used to test body fluids and tissue samples to obtain information for the purpose of diagnosing, preventing and treating disease.

Our leadership extends across the whole IVD spectrum, from centralised laboratory testing and point-of-care diagnostics to diabetes self-management. In addition, we supply cutting edge research tools to life scientists pursuing tomorrow’s medical advances. Research and development in the Business Areas focuses on disease areas where medical needs are great:

The business area continues to expand its instruments’ test menus, e.g. for tests, which will be used to detect hepatitis C virus in patients with established or suspected liver disease, and an anti-CCP (anti-cyclic citrullinated peptide antibody) assay for diagnosing rheumatoid arthritis.

Novel assays for PLGF (placenta growth factor) and sFlt1 (soluble fms-like tyrosine kinase 1) will also be introduced and will be among the first specific laboratory tests available for preeclampsia, a sometimes life-threatening complication of pregnancy.

To aid the diagnosis of sepsis during pregnancy, the business area will be launching immunoassays for the inflammation markers interleukin-6 (IL-6) and procalcitonin.

The test for IL-6, which is an early indicator of acute infection, will also be valuable in managing critically ill patients.

Work on new and improved cardiac tests remains a high priority. A next generation troponin T assay is expected to set new standards of sensitivity in the diagnosis of heart attack.

New laboratory systems include:

• the cobas c 311 clinical chemistry analyser for small to medium-size laboratories
• cobas u 411, the first cobas urinalysis instrument

Roche Diabetes Care continues to work on ways to simplify and improve diabetes  management. This is why the business area is investing in information management technologies to support better communication and collaboration between people with diabetes and their healthcare professionals.

Another focus is on integrated systems that reduce the number of test devices and steps required and on developing lancing devices and lancets that make blood sampling virtually painless.

The business area is pursuing the development of insulin guidance software and decision support programs that could help physicians and patients make better treatment decisions.

Work is also ongoing on a continuous glucose monitoring system. This is a long-term project aimed at developing a small, easy-to-use continuous monitoring system suitable for a broad spectrum of customers.

Cancer diagnostics remain a major research and development focus at Roche Molecular Diagnostics. Work is ongoing on tests to classify disease based on clinically relevant factors that affect prognosis and therapy selection.

For example, an AmpliChip p53 Test is being developed to identify cancers harbouring a dysfunctional p53 tumour suppressor gene. Mutations of the p53 gene are recognised as a significant prognostic factor in various cancers. The ultimate aim is to achieve better treatment outcomes by identifying the patients most likely to respond to particular medicines.

The business area is also working closely with Roche Pharmaceuticals and its partners on companion tests for new therapeutics, including a real-time PCR test to screen for a common cancer-causing mutation of the BRAFkinase gene.

Roche Applied Science’s priorities include developing new and more powerful NimbleGen microarrays and enhancing the flexibility and efficiency of Genome Sequencer technology for the research market.

Updates of the LightCycler 480 instrument and the MagNa Pure system, which prepares nucleic acid samples for PCR analysis, are currently in the pipeline and will offer customers higher throughputs and more seamless integration.

As part of the Roche Group’s personalised healthcare strategy, the business area has also stepped up work on tests with potential diagnostic applications and assay systems that may facilitate drug development, particularly in oncology and inflammatory diseases.

Within Discovery there are key initiatives that include core research/discovery that encompass

• Chemistry,
• Multiplexing,
• Molecular and Advanced Systems.

As new technologies are proven to be feasible by the Discovery team, they are transferred to the Development team for incorporation into new products. Within Development, there are key initiatives built around product development that include:

• Lean Workflow Solutions,
• Automation Platforms,
• IHC Assay Development,
• ISH Assay Development and Detection System (reagent) Development.