Roche Diagnostics is a global leader in healthcare, specializing in the development and provision of diagnostic solutions, including laboratory instruments, reagents, and tests.
Roche Diagnostics has recently announced a breakthrough in next generation sequencing (NGS). Could you tell us about the promises of your NGS technology in the field of genomics?
Roche has been at the forefront of genomics, the study of our DNA blueprint, ever since acquiring polymerase chain reaction (PCR) technology from Cetus Corporation more than three decades ago, an innovation that laid the foundation for our molecular diagnostics business. That acquisition was a pivotal moment and, since then, we have remained committed to supporting patients at every stage of their journey, from early detection of disease, to precise diagnosis, therapy selection, and continuous patient monitoring.
NGS presents a tremendous opportunity to enhance all of those areas. It enables early cancer detection, precise diagnosis of inherited and rare diseases, and identification of the molecular drivers of cancer—all of which help doctors to create more personalized and targeted treatments for patients. For example, NGS plays an important role in identifying and monitoring so-called minimal residual disease, where a small number of cancer cells, often undetectable by traditional methods, remain in the body. In this specific instance, NGS helps doctors to determine whether a patient has fully responded to treatment. As you can see, NGS is a critical technology for the future of healthcare and especially so in oncology.
You recently received FDA clearance for a unique oncology test. Could you use that example to illustrate how personalized medicine is changing diagnostics from Roche's point of view?
The test you are referring to is part of our immunohistochemistry business. By way of background, immunohistochemistry is a technique where doctors use special dyes to stain tissue samples from a patient. This helps them see if there is cancer present, or if the tissue is just showing a normal immune response, such as inflammation or swelling, as the body fights infections. This is crucial in differentiating cancer from other causes, allowing doctors to make a more accurate diagnosis and ensure that patients get the right treatment.
Looking once again at sequencing our DNA, we see even greater potential for personalized medicine. Through our subsidiary, Foundation Medicine, we can perform comprehensive genomic profiling to uncover the molecular basis of a tumor. This allows doctors to provide tailored treatments or to guide patients into the most appropriate clinical trials. Over time, this will enable us to move to a future where we understand the molecular drivers for cancer and can deliver truly personalized healthcare.
Moving towards personalized diagnostics is a positive trend, but it might come along with higher costs. What steps is Roche Diagnostics taking to address the issue of access? Relatedly, could you talk about the promises of point-of-care testing?
A great example of improving access is our self-collection HPV test, which received FDA approval last year. Cervical cancer is one of the most preventable cancers, yet it still causes many deaths globally. One barrier to access is sample collection. Allowing women to collect their own samples can significantly improve access. In Peru, for example, we are running a pilot with the Ministry of Health to roll this out in rural areas—something I’m personally familiar with from my time as Roche’s general manager in Peru.
As for point-of-care (POC), it is a major area of focus for us. We acquired LumiraDx, a flexible platform that can perform clinical chemistry, immunoassays, and, potentially, molecular tests—all on one device. It is portable, uses room-temperature reagents, and is Wi-Fi connected. It has huge potential to expand access for patients, not just in the developing world but in rural areas and pharmacies globally. You can use it to test for diseases like tuberculosis and diabetes in a single visit—helping address two major global health challenges in a cost-effective and more convenient way.
And then there is the blood test for Alzheimer’s which received a Breakthrough Device designation from the FDA…
You are absolutely right and we are proud of this test and the FDA’s designation. The blood test for Alzheimer's has the potential to significantly improve access to diagnosis. Alzheimer’s is projected to affect around 80 million people by 2030. Currently, diagnosis relies on expensive imaging and cognitive exams, often taking over two years for a definitive answer. Our blood-based test can accurately identify the absence of a build up of key proteins in the brain - a hallmark of Alzheimer’s disease - allowing clinicians to rule out Alzheimer’s disease as a possible cause of cognitive decline.
This could dramatically speed up diagnosis, allowing testing to happen in primary care settings, with only more complex cases being referred to specialists. It will improve access, lower healthcare costs, and help people get a definitive diagnosis earlier. The clinical trials were conducted with local settings, such as clinics or doctors’ surgeries in mind, enabling tests to be accessed more easily by as many people as possible.
How is your team leveraging AI to improve diagnostics?
AI is becoming central to diagnostics. It allows us to combine data from lab results and patient visits to generate more precise insights. A good example is our Algorithm Suite, which incorporates algorithms for conditions like hepatocellular carcinoma and, in the future, cardiovascular disease. These insights are already improving the precision of diagnostics.
Another key example is our continuous glucose monitor (CGM), the Accu-Chek SmartGuide CGM, launched last year. It includes two AI-powered algorithms: one predicts glucose levels two hours ahead, and the other estimates nighttime risk of hypo- or hyperglycemic events. These tools empower people with diabetes to plan their lives better and mitigate risks, addressing a major concern for those living with the condition.
What do you see as the most significant emerging trend in diagnostics?
I would highlight two major trends. First is the shift toward more personalized diagnostics. Technologies like next-generation sequencing, our automated mass spectrometry system, and algorithm-driven clinical insights are shaping a future of diagnostics that is more personalized and insightful for patients.
Second is the decentralization of care, which accelerated post-pandemic. There is a growing need to bring testing closer to patients—reducing costs and improving outcomes. That is why we are investing in point-of-care platforms like LumiraDx and focusing on technologies like continuous glucose monitoring. Together, these trends—disruptive technologies at the center and decentralized testing—are transforming diagnostics to be more accessible, efficient, and patient-centred.
