Driving diagnostic certainty for life-changing decisions in oncology
Cancer begins to form when a disruption occurs in the cell replication cycle. Mutations and damage to the cellular DNA can cause these disruptions, and uncontrolled replication of these cells can result in a tumor. The tumor can then become benign, premalignant, or malignant. If malignant, the mass may grow and affect the function of the organ, surrounding tissues and even spread to other parts of the body as metastatic tumors.
Receiving a cancer diagnosis is personal. Its impact can affect not just the person but their community. Access to diagnostic tools is crucial for screening and monitoring, early prevention and treatment decisions and disease management.
Committed to continuously improving oncology diagnostics
Cancer has been one of the top two leading causes of death in the U.S. for more than 75 years.1 As an experienced leader in oncology, Roche is at the forefront of the battle against cancer, bringing together expertise and investment to enhance cancer care and fund innovative research. Our extensive portfolio of diagnostic solutions across testing disciplines such as immunochemistry, molecular testing, sequencing, immunohistochemistry, in situ hybridization and digital insights, ensures laboratories and healthcare professionals have the tools they need to give patients the care they deserve.2
As a sustainable and collaborative partner to the oncology community, we are committed to optimizing and future-proofing our partners' oncology capabilities so that they can continue the global fight against cancer.
A complex diagnostic landscape
Our understanding of cancer has increased dramatically and continues to evolve. Recent years have seen notable progress in the ability to manage the disease and diagnostics play a critical role, however as the incidence of cancer grows and more testing is required, healthcare providers face pressure to adapt and evolve.2
Conventional diagnostic techniques such as in situ hybridization (ISH), fluorescent ISH (FISH), and single-gene testing require biomarkers to be pre-specified in some cases in order to be tested. With the number of relevant biomarkers increasing year to year, healthcare providers are unable to test for them all and are therefore facing an incomplete picture when diagnosing.3 Added to this, the growing amount of data points available to healthcare professionals makes it increasingly complex to make reliable clinical decisions.
We have also seen substantial changes in the way patients with cancer are managed, from a “one-size-fits-all” approach to increasing focus on precision medicine which brings additional complexity to healthcare professionals and disparities in access.3
A lack of access to affordable, high-quality diagnosis and treatment and resulting late- stage diagnosis, means that the greatest increases in cancer-related mortality will be in low- and middle-income countries.4 For example, in breast cancer an early diagnosis significantly improves survival rates, and the stage at diagnosis varies widely across different countries and regions. Late-stage diagnosis occurs in around 6% of women in the U.S. compared with 75% of sub-Saharan African women, emphasizing the importance of early diagnosis strategies.5
Helping to improve access to timely, accurate screening and diagnosis for people, especially in resource-limited regions, is more important than ever. That’s why we are working closely with governments and policy makers, to improve access and ensure Roche creates long-term impact not only for patients, but society as a whole.6
Featured products
Innovative diagnostic solutions empowering informed and precise breast cancer care.
A broad range of different biomarkers and diagnostic solutions to uncover the holistic image of the lung cancer patient.
Benefits of Roche diagnostic solutions for managing oncology
An experienced provider and innovator in the field of in vitro diagnostics
At Roche, we relentlessly work to push the standards of excellence higher. We bring together expertise and investment to solve problems in oncology and fund innovative research:
- Trusted diagnostic solutions: Over 29 billion tests completed in 2023 to aid healthcare providers to improve patient care.6
- Innovative approach: Our vision is integrated digital diagnostics and disease management solutions for complete patient profiles, confident decision-making, and efficiencies. In 2023 alone, we introduced 6 new platforms, 21 tests, and 7 digital solutions.6 We are accelerating the power of digital insights through our navify® digital solutions portfolio.7
- Investing for the future: Our research portfolio plays a pivotal role in the pursuit of groundbreaking discoveries in the field of cancer diagnostics. More than 200 early phase biomarker projects continue to feed a rich companion diagnostic pipeline of predictive diagnostics and other high medical value assays.8
Enabling clinicians to make decisions that lead to better patient outcomes
Oncology diagnostic solutions can be complex, fragmented and inconsistent. Roche provides a breadth of solutions across testing disciplines - immunochemistry, molecular testing, sequencing, immunohistochemistry, in situ hybridization and digital insights - to support healthcare professionals to make life-changing decisions.2 Oncology teams need diagnostic certainty. Our aim is to simplify and optimize processes to enable the best possible care decisions for every patient by:
- Empowering pathologists: We offer a growing list of Roche-developed image analysis algorithms and partner with third-party algorithm developers to enable pathologists to quickly, accurately and confidently assess whole tissue slide images.9
- Increasing access to targeted treatment: In line with relevant medical guidelines, ensuring samples are used in the most impactful way and providing diagnostic options for different patient needs: sample type, cost vs. turn-around-time, or less invasive options.2
A sustainable partnership for support and consultancy
At Roche we are focused on helping our partners improve labs and lives through flexible, sustainable solutions and close collaboration with the global oncology community through:
- Ongoing partnerships: We have more than 85 ongoing collaborations with 95+ pharma partners10 to develop companion diagnostics that advance personalized treatment. Additionally, we work with vendors to foster the development of new diagnostics solutions, with digital solutions playing an increasing role.
- Healthcare consultancy: Our healthcare consultants collaborate to implement enhanced diagnostics in partner organizations and ensure standardization and compliance with medical support. Our goal is to help partners optimize performance, add value, and adapt to evolving health policies, ultimately enhancing patient care and business outcomes.
- Expanding access: In 2014, recognizing that diagnostics is an integral component of functioning health systems, Roche launched the Global Access Program to enable access to reliable testing solutions for patients in low- and low-middle-income countries.11 We work with governments and policymakers, to improve access and ensure Roche creates long-term impact not only for patients, but society as a whole.6
Our innovation
Driven by our passion for what we do, our flexibility in how we find solutions, and the strength of our R&D structure, we can take on the most complex challenges in healthcare. In companion diagnostics and digital pathology, we tap a strong network of internal and external partners to drive the creativity and innovation needed for today and tomorrow.
Digital Pathology
Personalized healthcare is here, and digital pathology is at the core of this patient-centered innovation. As cancer cases continue to rise and fewer pathologists enter the profession, Roche is dedicated to creating a true digital ecosystem including advanced workflow solutions, digital imaging and artificial intelligence–based algorithms. These solutions are designed to improve workflow efficiencies to enhance collaboration and provide accurate insights.
Companion Diagnostics
A companion diagnostic (CDx) in oncology is a test that provides information about a patient’s tumor and informs whether an available drug therapy can be used that’s safe and effective for that individual patient. CDx are an important part of personalized medicine or patient-specific treatment.
The first CDx test approved by the FDA, in 1998, assessed cells that over-produce the HER2 protein for breast cancer patients.
Today, the list of companion diagnostics used to help treat tumors and cancers of the blood is expansive and growing.
- 2025: The future of cancer diagnostics in the Pathology Lab
- Roche receives FDA approval for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay as the first IHC-based companion diagnostic to identify ovarian cancer patients eligible for ELAHERE
- Roche receives FDA approval for first companion diagnostic to identify patients with HER2-low metastatic breast cancer eligible for ENHERTU
CDx and digital pathology will also begin to intersect with the future development of new CDx algorithms. There will also be some CDx that will only be used to score with digital pathology because the slide can’t be evaluated with the naked eye. We should expect to see improvement in biomarker development and CDx performance with AI-based technology.
Our focus areas
The best oncology drugs in the world are most effective when we link them to the right patients. Diagnostics help us make that connection and strengthen personalized healthcare.
Breast
One in three female cancers is diagnosed as breast cancer. Contrary to popular belief, breast cancer isn't just one disease and it impacts men as well. Breast cancer is characterized by the expression, or lack of expression, of estrogen receptors (ER), progesterone receptors (PR), and human epidermal growth factor receptor 2 (HER2). Targeted therapies exist to determine the most appropriate approach based on a patient's expression of these receptors.
We know having access to the most comprehensive diagnostic assays is essential to providing personalized cancer care.
Cervical
Cervical cancer affects around 14,000 people with a cervix in the United States each year. The link between cervical cancer and human papillomavirus (HPV) is clear. Persistent HPV infections with high-risk genotypes account for almost all cervical cancer diagnoses.
Access to screenings and vaccinations can help prevent the development of cervical cancer. Treatment is more successful when persistent HPV infection is detected early and before it evolves into cancer.
Lung
Lung cancer is the second most common cancer for both men and women. There are many different types of lung cancer, and the two main subtypes are non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
Lung cancer diagnosis and treatment is complex, and we're committed to developing comprehensive diagnostic tools to improve a patient's healthcare journey.
Related health topics
References:
- Cancer Deaths. CDC.gov. Available from https://www.cdc.gov/nchs/hus/topics/cancer-deaths.htm [Accessed March 2025]
- F. Hoffmann-La Roche Ltd. Diagnostics in oncology. Available from https://www.roche.com/solutions/focus-areas/oncology/diagnostics-in-oncology [Accessed May 2024]
- Malone et al. (2020) ‘Molecular profiling for precision cancer therapies’ Genome Med. 12: 8. Available from https://genomemedicine.biomedcentral.com/articles/10.1186/s13073-019-0703-1 [Accessed May 2024]
- Sung H et al. (2021) Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 71,209–24 Available from https://pubmed.ncbi.nlm.nih.gov/33538338/ [Accessed May 2024]
- F. Hoffmann-La Roche Ltd. Ensuring early and accurate diagnosis to improve access to healthcare. Available from https://www.roche.com/about/strategy/access-to-healthcare/diagnosis [Accessed May 2024]
- F. Hoffmann-La Roche Ltd. Annual Report 2023.Available from: https://www.roche.com/investors/annualreport23 [Accessed May 2024]
- F. Hoffmann-La Roche Ltd. Navify® Portal. Available from https://diagnostics.roche.com/gb/en/services/dialog.html [Accessed May 2024]
- F. Hoffmann-La Roche Ltd. Forecasting the future of cancer diagnostics 2023 Available fromhttps://diagnostics.roche.com/us/en/article-listing/forecasting-future-roche-cancer-diagnostics-2023.html [Accessed May 2024]
- F. Hoffmann-La Roche Ltd. Digital pathology image analysis algorithms. Available from: https://diagnostics.roche.com/global/en/article-listing/digital-pathology-image-analysis-algorithms.html [Accessed May 2024]
- Roche Diagnostics Ltd. Data on file. MC—06186
- F. Hoffmann-La Roche Ltd. Global Access Program. Available from: https://diagnostics.roche.com/global/en/article-listing/global-access-program.html [Accessed May 2024]