Roche's heterogeneous immunoassays

Centralized and Point of Care Solutions

Our assays work on the principle of immunodiagnostics and use antibodies to detect diagnostic parameters. Together with the highly precise instruments they fulfil the most varied lab requirements.

Light years ahead

Roche's heterogeneous immunoassays use what is konwn as ECL (electrochemiluminescence) technology, a unique measurement principle. First the test reagents react to the substance to be detected (measurand) in a controlled process, forming a chemical complex. Then more test reagents are added and an electrical voltage is applied to generate a light signal. The higher the concentration of the measurand, the more intense the light signal. This means that "the light goes on" when an analyte is detected in the sample.

The lock and key principle in immunodiagnostics

Immunodiagnostics follows an important basic principle of the human immune system: development of antibodies against foreign substances (known as antigens). Antibodies bind as exact fits to their antigens. This is known as the lock and key principle. Today, antibodies can be industrially manufactured and used in immunodiagnostics to specifically detect antigens in blood samples.

Assay production of Roche's heterogeneous immunoassays test reagents

Each second more than 60 patient samples are measured by Roche's immunoassay reagents somewhere in the world. Just a few molecules are enough to produce a reliable result.

~ 40,000

analyzers in use around the world


different analytes contained in test menu

~ 2

billion tests run on the devices worldwide every year

Since the introduction of the first ECL based tests over 20 years ago, Roche has developed into the market leader in immunodiagnostics. Our immunoassays stand for high quality and reliable results for our customers and patients. Our technology are sensitive enough to detect a dissolved sugar cube in Lake Starnberg.

Our challenge today: How do we make something that brilliant even better...?

Immunoassay development at Roche requires deep understanding of biological, chemical and physical principles and bringing them together.

It is our mission and our challenge to continually meet the standards of our existing products and in the development of new tests. That's why we need to constantly work on improving the components of this unique technology.

Transferring the results from the lab into the production can be challenging. Keeping the timelines by coordinating the resources and actively exchanging with many other departments in the company. The accurate documentation of all relevant development and production steps is also important for the success.

The tasks in the assay development offer a wide and varied spectrum.

The premise that puts Roche's immunoassays light years ahead remains its unique measurement principle known as ECL (electrochemiluminescence) technology.

But to remain successful, it is crucial to employ the best scientists that work with the best engineers and apply the most advanced technologies.

Immunoassay development at Roche is an interesting and diverse mission. Finding the best solution is done by cooperation between system integration, rare reagents development and reagent design.

"It is good to know that we work every day to improve healthcare by bringing automation to the lab and innovative highest quality immunodiagnostics to the patient. Our results matter."

Dr. Beatus Ofenloch-Haehnle
Head of R&D Heterogeneous Assays & Lab Systems

Reliability and accuracy of the instruments are key for our highly sophisticated lab automation solutions. That is why we have been cooperating with HITACHI for over 40 years. The partnership provides the basis for the perfect harmony between the instruments and the reagents.

Thanks to our scientists and engineers, the assay portfolio is the most comprehensive in the market covering...

Hepatitis, HIV, Oncology, Thyroid, Fertility, Cardiology, Hormones, Inflammation, Brain Damage, Pregnancy, TORCH, Immunosuppressiva, Anemia and Companion Diagnostics for Personalised Healthcare.

Our main department in Penzberg has around 200 colleagues, who are involved in test development and system integration. Many experts from a wide range of disciplines work together here.

At the new Roche diagnostic production facility in Suzhou, China, we have a field office with around 20 employees who support the new plant with R&D know-how.

We work together, share information and help each other to find the best solution. We use state-of-the-art technologies and best practices to provide high quality IVD products to the patients.

In the end it means not only assay development but also personal development.

The story of our products and technology is a story of success. To continue this way, we are permanently searching for new markers, exploring new indication areas and closing menu gaps. For this journey we need creative people, that have a passion to solve complex questions and drive the diagnostics of tomorrow.