Laboratory diagnostics – crucial foundation for advances in medical science

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Roche Diagnostics Deutschland GmbH

In 2009 for example, Roche introduced two very important tests for expectant mothers. Preeclampsia, also known as pregnancy poisoning, is a frequent complication during pregnancy and can be life threatening for mother and child if diagnosed late. If the condition is suspected, the mothers must be kept under observation in the hospital, and in the worst case the baby must be delivered early. The preeclampsia tests Elecsys sFlt-1 and Elecsys PlGF measure the proteins sFlt-1 (soluble fms-like tyrosine kinase-1) and PlGF (placental growth factor) in the mother's blood. The result of the test is expressed as the ratio of the two measurements and provides a basis for assessing the risk that women with suspect symptoms over a certain length of time will (or will not) develop preeclampsia. In 2016, the results of the PROGNOSIS study [3] validated the predictive value of the Roche test and the clinical value of the sFlt-1/PlGF ratio for women with clinical suspicion of preeclampsia. The test helps improve the outcome of the pregnancy for mother and child. Not only that, cost-intensive hospitalization which places a burden on the mother and on the health care system can be avoided.

Increasing demand for PCR

In parallel, PCR has added an additional dimension to the Roche diagnostics business since 1991. The company acquired worldwide rights to Cetus Corporation's PCR technology, opening the door to development of diagnostic tests which are highly sensitive, fast and specific as well as to support a broad spectrum of medical and research-relevant applications. The Roche Molecular Diagnostics (RMD) business in Pleasanton is also founded. At the time, development of the PCR technique was largely complete, but it was by no means ready for the mainstream. Roche worked to make practical, affordable PCR techniques available for diagnosis of disease, for example to find the cause of virus infections and detect genetic variations and mutations as possible predisposition markers or therapeutic targets. Roche continues to invest in new parameters, test formats and automation solutions. Introduced in 1998, the Lightcycler system set new standards in high-speed, real time PCR analysis.

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In 2005, Roche introduced the first HPV test for improved cervical cancer screening. In the 1980's, Harald zur Hausen identified persistent human papillomavirus (HPV) infection of the cervix as the cause of cervical cancer. This created new possibilities for prevention and treatment, and subsequently led to the development of sHPV vaccines. In 2008, zur Hausen was awarded the Nobel Prize for Physiology or Medicine. Roche Cobas HPV tests are qualitative in vitro tests for PCR-based detection of HPV DNA in patient samples. With a single analysis, the tests individually characterize the HPV genotypes with the highest oncogenic risk (HPV 16 and HPV 18) and provide an aggregate result for 12 additional high-risk HPVs. So far, the Cobas HPV test which runs on the Cobas 4800 system is the only test for the detection of hrHPV which has been approved by the FDA for all screening populations.

The cytology-based Pap smear test has been used for cervical cancer screening in Germany since 1971. The incidence and mortality rate of cervical cancer decreased significantly during this period, but the test has shortcomings. Pathological changes can be missed due to misinterpretation of the results or patients could be subjected to excessive therapy. Despite the fact that numerous studies demonstrate the medical and economic benefits of HPV testing during primary screening and many countries have completely revamped their screening programs, HPV testing has not been incorporated into the standard care system for patients in Germany. However, there has now been some movement. New early detection guidelines stipulating a combination of HPV testing and cytological examination are expected to be introduced in 2019.

The Cobas Liat System (see LP Tip and Fig. 4) introduced by Roche in 2017 provides PCR capability in the point-of-care segment for rapid testing in the hospital. The high-speed, compact, user-friendly molecular diagnostics platform facilitates and speeds up the diagnosis of infectious disease. In this way, individual samples can be processed outside of normal working hours and at remote locations such as emergency laboratories in close proximity to patients. The results are available in 30 minutes maximum.

Portfolio consolidation

Advances in medical science increase the level of complexity and that, together with increasing cost pressure, creates the need for innovative, efficient, reliable solutions for central laboratories, physicians' offices and patients at home. With this firmly in mind, Roche Diagnostics has continued to develop and expand its portfolio. The list of priorities includes the number of parameters that can be handled, the level of automation on the analysis platforms, the development of point-of-care solutions, the speed, accuracy and sensitivity of the assays and the underlying technology.

Building on strengths such as the partnership with Hitachi which was originally forged by Boehringer Mannheim, Roche has embarked on a strategy of equipment portfolio consolidation for routine diagnostics along with increasing modularization and full-scale automation. The Hitachi 705, first introduced in 1981, was the world's first clinical chemistry analyzer for automated, selective sample processing (random access). The Elecsys 2010, unveiled in 1996, was the first analyzer which was based on innovative ECL technology described above.

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