Roche breast cancer diagnostics portfolio

Guiding the way to personalized treatment

Breast cancer is the most common cancer among women worldwide.1

Early detection, innovative testing, and new therapies contributed to a 40% reduction in breast cancer mortality rate over the past few decades,2 but there is still much work to be done.

Today, breast cancer continues to claim nearly 600,000 lives annually.¹ Every breast tissue sample you receive represents someone’s life—their questions, hopes and aspirations are in your hands. We are inspired by the work you do for patients every day, and we remain committed to supporting you with new and advanced diagnostic tools that have the potential to profoundly change lives.

research refine
Research, refine, and start again – our determination is unwavering

Cancer is personal, and we believe that care should be, too. As our understanding of breast cancer grows, our portfolio of sensitive and clinically actionable solutions evolves with it.

Since 1991, Roche has battled cancer with innovation to push standards of care forward and bring clarity to the most complex disease pathways. Continually working to improve our assays allows us to deliver better sensitivity, generate deeper insights, and empower you with ever-increasing confidence in diagnosing your patients. Our proven foundation is enabling us to expand our transformative technologies across a broad spectrum of indications.

Confidently navigate the complexities of breast cancer

The Roche Breast Cancer Diagnostics Portfolio offers the clinical utility you need to consistently deliver confident results patients need. From diagnostic and predictive assays to pathologist-trained image analysis algorithms, the solution for precise, personalized treatment has never been so clear.

Confidently navigate the complexities of breast cancer
Breaking new ground – spotlight on triple negative breast cancer
Triple-negative breast cancer (TNBC) accounts for ~15% of all breast cancers.3 Until recently, patients with metastatic TNBC (mTNBC) had an estimated median survival time of just 12-18 months, and no targeted therapy was available.4


In 2019, Roche launched the VENTANA PD-L1 (SP142) Assay—the first FDA approved and CE-IVD marked device to identify TNBC patients for immunotherapy. Using this novel test, pathologists can identify patients who are likely to benefit from treatment with a breakthrough immunotherapy, bringing new hope to thousands.

Reimagining HER2 testing – our mission compels us to make even our best tools better
To us, innovation means more than developing new products, we also seek opportunities to enhance the technology we have on the market today—because better diagnostic tools mean greater confidence and improved patient outcomes

HER2-related cancers account for 15-20% of all breast cancers.5 While many labs have relied on our INFORM HER2 Dual ISH assay for HER2 related breast cancer diagnostics, customer feedback told us that making the test easier to use would increase its value.

Today, our reinvented VENTANA HER2 Dual ISH DNA Probe Cocktail builds upon the elements that made the original product successful—including easy reads with brightfield microscopy, interpretation within the context of tissue morphology, and archivable results.

By refining the science behind the test, pathology labs can more confidently uncover the story behind the slide.

The uPath HER2 (4B5) image analysis algorithm (CE-IVD) for breast cancer
Empowering precision diagnosis with image analysis algorithms for clinical decision support

Roche is continuing to innovate in HER2 diagnostics with image analysis algorithms that support the decisions you make in pathology. The pathologist-trained artificial intelligence algorithms provide an actionable assessment of scanned slide images that are objective and reproducible.


The uPath HER2 (4B5) image analysis, Breast algorithm (CE-IVD):


Helps pathologists quickly determine whether tumours are positive for the HER2 biomarker, clearly highlighting positively stained tumour cell membrane. When used with the VENTANA HER2 (4B5) assay, patients that are positive for the HER2 biomarker may be eligible for targeted treatment.


The uPath HER2 Dual ISH image analysis, Breast algorithm (CE-IVD):


Helps pathologists to determine HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17. When used with the VENTANA HER2 Dual ISH assay, it is indicated as an aid in the assessment of breast cancer patients for HER2 targeted treatment.


Dive into the details of our comprehensive portfolio

Making even the toughest calls easier

The emerging era of immunotherapy demands more complex assays – and so our journey to innovate breast cancer testing continues. Through an enduring commitment to continuous innovation and exceptional quality,7 we are working to expand our portfolio through additional image analysis algorithms that minimize variables and support consistent, confident decision making.

As we pursue an end-to-end solution for breast cancer diagnostics, Roche is moving powerful tools that were traditionally available only for research into clinical practice. This means new capabilities and increased confidence for pathology professionals, and new hope for patients around the world who are counting on us to continually reimagine breast cancer care.

BenchMark ULTRA IHC/ISH System

BenchMark ULTRA system

The BenchMark ULTRA IHC instrument is for the pathology professional who values improved quality, reliability and workflow efficiency.


  1. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424.
  2. Data on file from Roche.

  3. Székely B, Silber AL, Pusztai L. New Therapeutic Strategies for Triple-Negative Breast Cancer. Oncology (Williston Park). 2017;31(2):130–137.
  4. Vernieri C, Mennitto A, Prisciandaro M, et al. The neutrophil-to-lymphocyte and platelet-to-lymphocyte ratios predict efficacy of platinum-based chemotherapy in patients with metastatic triple negative breast cancer. Sci Rep. 2018;8(1):8703.
  5. Sareyeldin RM, Gupta I, Al-Hashimi I, et al. Gene Expression and miRNAs Profiling: Function and Regulation in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer. Cancers (Basel). 2019;11(5):646.
  6. Package Insert, VENTANA HER2 Dual ISH DNA Probe Cocktail. (eLabDoc).
  7. Data on file from Roche.