Uncovering Roche’s Deep Diagnostic Roots as it Seeks to Make Tomorrow’s Medicine Better

As cholera ravaged the usually vibrant city of Hamburg in 1892, a young Fritz Hoffmann, shocked by the grotesque scenes of suffering, pledged to create a company that would make medicine better. That company is F. Hoffmann-La Roche AG, or more commonly known as Roche.

As a merchant, not a scientist, Hoffmann encouraged his employees to pursue the technologies that would solve the medical challenges of the day. He did not bind Roche to the singular technology of chemical synthesis that was favored by most other pharmaceutical companies at the time. Instead, he gave his scientists the freedom to explore other ways of developing new medicinal tonics, such as extraction chemistry.

This liberal approach to achieving excellence in medicine has seen Roche continuously push the boundaries of scientific possibilities and repeatedly establish itself as a pioneer of cutting-edge healthcare solutions across a multitude of disease areas, including infectious diseases, oncology and neuroscience.

Although best known to many – depending on their vintage – as a vitamins company or for sedatives, such as Valium, or for life-changing cancer medicines, including Avastin, Herceptin and Tecentriq, Roche has also long been leading the way in the area of diagnostics. 

As we move into a more connected, data-driven and digitally-enabled era of healthcare management and delivery that is dependent on crucial advances in diagnostic capabilities, we reflect on the humble beginnings of Roche’s diagnostics story. We also look at what Roche’s past means for patients today as well as what it may predict about how we protect and care for our health and well-being in the years ahead of us.

Entrepreneurial Spirit and Inventiveness

Roche’s first foray into diagnostics dates back to the 1920s when it started to produce biochemicals that were used to gain better understanding into certain illnesses, with the first Point of Care Test rolled out at the start of the following decade. 

“In the early 1930s, with the launch of ascorbic acid, the first near-patient test kits were produced to establish how much Vitamin C, or ascorbic acid, was in the bloodstream of patients, and to establish whether they were suffering from hypovitaminosis. This was basically Roche’s first step into diagnostics,” Alexander Bieri, Curator of the Roche Historical Collection and Archive says.

But it wasn’t until the 1960s that work on diagnostics solutions really began in earnest when Roche’s top managers opted to expand their research and development to areas beyond infectious diseases. Realizing physicians would need diagnostic support when prescribing medicines for complex diseases like cancer, Roche executives spotted an opportunity to expand its product offering beyond pharmaceutical products.

“This is when Roche started to acquire other companies to assemble the knowledge required to create its own products and devices. Investments back then were very similar to what we are doing now with investments in informatics and in data,” Bieri says.

Somewhat unexpectedly perhaps for a maker of medicines, Roche began to snap up stakes in engineering and electronics companies, including the medical research unit of Radio Corporation of America, then producers of iron lungs, in a bid to understand the mechanics of medicine. 

Other Swiss companies were bought and integrated into the newly founded Tegimenta, laying the foundations for today’s instrument production at Rotkreuz in Switzerland. Kontron, a producer of centrifuges, was acquired in 1973, a move that brought Roche into the field of ultrasound diagnostics. And it was around this time that the first in-vitro analyzer, the Cobas Bio, was launched. 

“There were also other fields, like the development of the liquid crystal display, which was invented by Roche in order to make diagnostic devices more transportable. And all of this was feeding into the spirit of the 1960s, of branching out into new technological fields, like molecular biology with the establishment of the Roche Institute of Molecular Biology, with the establishment of the Basel Institute for Immunology, and with the establishment of the Diagnostics Division that we know today,” Bieri says.  

Making Medicine Better

Nearly a century after the cholera epidemic that Fritz Hoffmann witnessed in Hamburg, an unknown and deadly virus began to take hold across the world. By the end of 1981, the first case of AIDS – the full blown disease state of HIV – was documented.¹ The first medicine for AIDS did not come until 1987. But there was another issue – understanding a patient’s viral load was going to be an essential part of providing the right therapeutic care for people with the virus.

“The polymerase chain reaction (PCR) technology was really triggered very much by HIV and AIDS, and by the pharma division’s need to find a quantitative test to assess the viral load in the patient’s bloodstream,” Bieri says.

“The therapeutic concept was that you would develop chemical scissors for each step in the development cycle of the virus in the patient’s body. But, of course, you couldn’t combine these therapies in a sensible way if you were not able to monitor the viral load in the patient’s blood. Roche realized in 1989 that the PCR technology might be a way of doing so,” Bieri says.

Roche set about automating the PCR technology, which until this point had mainly been used in the area of research. Amplicor became the first automatic PCR system to enter the market when it was launched in 1994, making it possible for clinicians to effectively and safely combine the different medicines that were needed to manage people’s viral loads.

PCR testing has revolutionized medicine and played a crucial role in biology and biomedical research thanks to its ability to swiftly produce millions to billions of copies of a DNA segment that can be studied and analyzed in more detail.² 

Most recently, PCR testing was instrumental in identifying COVID-19 and mutated strains amongst the world’s population, providing authorities with the vital information they needed to make potentially life-saving public health decisions.

Creating Value

Since the mid-1990s, Roche has sought to produce highly automated analysis equipment that can process thousands of samples a day. Developing equipment that can produce results faster than before has also been a priority for Roche. 

The Amplicor was replaced with TaqMan, a simplified and faster version of its predecessor. The LightCycler, which Roche gained access to when it acquired Boehringer Mannheim, set new standards in PCR diagnostics in 1997; now results were produced in 15-30 minutes instead of two to three hours.

“The aim of all these developments was to provide doctors with speedy, reliable and precise data for a diagnosis by means of standardized, automated procedures and to relieve laboratory staff of the burden of dealing with a constantly increasing number of samples and available test procedures,” Christian Helm notes in Roche in the World, an overview of Roche’s history.³

Today, Roche’s diagnostic product portfolio spans 17 disease areas, including oncology, infectious diseases, cardiometabolic disease and diseases of the central nervous system. The company is working with partners around the world to equip healthcare systems with a wide range of digital health solutions, in-vitro tests and instruments, with many tracing their roots back to the investments made into the state-of-the-art engineering and lab automation of the 1960s. 

Making It Personal

Meanwhile, advances in molecular biology mean Companion Diagnostics are being used to make sure the right patients are getting the right medicine at the right time.

Already, Roche has rewritten the medical textbooks when it comes to delivering highly targeted medicines for a number of cancer types, most notably HER2-positive breast cancer – a particularly aggressive form of the disease.

By understanding and detecting the genetic mutations involved in diseases, Roche and other pharmaceutical companies are developing much more personalized therapeutic agents.

As we look at today’s healthcare systems that are buckling under the enormous pressures of increased demand and dwindling resources, the need for personalized healthcare solutions that improve outcomes for individual patients and deliver more efficient, affordable and sustainable care for entire populations is clear.

Fundamental to this, is incorporating accurate diagnostic tools that are used as quickly as possible, while the use of remote monitoring tools can also help to track how well a targeted treatment is working for the patient on a daily basis and keep them connected to healthcare providers, who can adjust the course of care as needed.⁴

Advances in science, data, analytics, computation and digital technology mean we can gain more clarity about a person’s health than ever before. We are only at the beginning of understanding the possibilities that will open up to us and the ways in which we can harness these opportunities to make medicine better for the next generation. Visit Roche at EuroMedLab 2023 to find out what the future could hold.