Roche Diagnostics, a Division of the Roche Group, and Prionics Inc., a Zürich-based biotechnology company, have agreed on a collaboration that will respond to the increasing demand throughout Europe for validated tests for BSE (bovine spongiform encephalopathy). In 1998, Prionics, a spin-off company founded by distinguished prion researchers at the University of Zürich, introduced Prionics-Check, the first specific and rapid test for the detection of BSE (“mad cow disease”) in cattle. On February 1st Roche Diagnostics is to take over distribution of Prionics-Check in virtually all markets.

The collaborative agreement between Roche Diagnostics and Prionics, the leading company in the field of prion diagnostics, is intended to ensure that the growing demand for reliable and sensitive tests for BSE that has arisen as a result of the BSE crisis can continue to be met. Distribution of the test is to be taken over by Roche Molecular Biochemicals, a business unit of Roche Diagnostics that supplies scientists throughout the world with new diagnostic systems and that for decades has cultivated close links with national veterinary authorities and their testing laboratories.

In joint work with Prionics Roche Diagnostics is to make use of the know-how available at its Penzberg site on the further development of Prionics-Check – which is already a fast, robust, and cheap diagnostic test. This cooperative work, to which Roche will contribute in particular its expertise in test automation, is to focus on the development of more user-friendly tests.

At present only dead animals can be tested for the presence of BSE. One of the most pressing needs in relation to this deadly disease is therefore the development of a blood test. Only by means of such a test will it be possible to test live animals for BSE. “or Roche Diagnostics, with its wealth of know-how in the field of blood-based diagnostics, the development of a blood test for BSE is a top priority”, pointed out Heino von Prondzynski, head of Roche’s Diagnostics Division and a member of the Executive Committee, adding that “the close partnership between Roche Diagnostics and Prionics will ensure that the increasing world-wide demand for Prionics-Check can be met and that high-quality technical backup can be provided at an international level.”

In addition to its effects on people’s eating habits, the increasing spread of BSE is also having an impact on blood banks. Manfred Baier, head of Roche Molecular Biochemicals, therefore stated that “as a leading industrial company working together with many research institutions throughout the world, we see it as one of our highest priorities to develop a blood test by means of which Creutzfeldt-Jakob Disease, the fatal disease of humans that appears to be closely related to BSE, can be detected as early and as specifically as possible.”

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Dr. Bruno Oesch, a prion expert and one of the three cofounders of Prionics Inc., stated that “given Roche’s high level of competence in the development of new diagnostic methods and Prionics’ expertise in prion diagnostics, I expect this collaboration to considerably accelerate the development of new tests. An additional bonus for a young company such as ours is the fact that our customer service will be greatly strengthened by the experience and good reputation of Roche’s distribution and service network.” Dr. Markus Moser, another of the cofounders of Prionics, commented as follows: “A key point for us is the fact that Prionics is to remain completely independent and will thus be able to continue developing its strengths as a young, research-oriented company.”

Prionics-Check was validated by the Swiss Federal Veterinary Office and the BSE Reference Centre of the University of Bern in the spring of 1998. Since then many European countries have adopted it as an official test for the purpose of BSE surveillance. All the validation procedures, field studies, and surveillance programmes in which the test has been employed to date have confirmed its superior specificity, sensitivity, and reliability. It can detect BSE in beef cattle as early as six months before the appearance of the typical symptoms. It is based on the Western blot technique and is so specific and reliable that even now, after very extensive use in the field, it has yet to yield a single false-positive result, with all the serious consequences that can arise from this.

Prionics Inc., a young biotechnology company based at the University of Zürich, was founded in the spring of 1997 by three prion researchers, Dr. Bruno Oesch, Dr. Markus Moser, and Dr. Carsten Korth, with the aim of exploiting discoveries made at the University of Zürich in the field of prion diagnostics. The canton of Zürich, the holder of the patents concerned, has assigned all its exploitation rights to Prionics Inc.

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-based healthcare groups in the fields of pharmaceuticals, diagnostics, and vitamins. Roche’s innovative products and services address prevention, diagnosis, and treatment of diseases, thus enhancing people’s wellbeing and quality of life. Roche employs around 64,000 people and markets its products in over 170 countries. Its Diagnostics Division supplies a broad range of innovative diagnostic tests and services for use by doctors, patients, researchers, hospitals, and laboratories throughout the world.