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Companion diagnostics (CDx)

Driving diagnostic certainty for life-changing decisions in precision oncology with the broadest menu of companion diagnostic tests available today.1


A patient explores cancer treatment options with an oncologist based on his companion diagnostic test results

Delivering on the promise of precision medicine

Focused on innovations that impact outcomes

For nearly 25 years, Roche has been at the forefront of innovating companion diagnostics (CDx) that hold the power to transform patients’ lives by providing essential information that informs clinical decision-making and guides personalized treatment strategies.

With a steady pipeline of high medical value predictive tests fueled by collaborations with over 85 pharmaceutical partners, we deliver diagnostic certainty through the broadest menu of immunohistochemistry/in situ hybridization (IHC/ISH) companion diagnostics available today.1 We empower pathology professionals to consistently deliver reliable, timely results so that clinicians can make the right therapeutic decisions more quickly and offer more hope to patients and their loved ones.

Leading the way in changing the practice of cancer care

We are committed to ongoing innovation that changes healthcare standards. Our goal is to take customers further on their journey to maximize their impact on patients by linking diagnoses with more personalized options and improved outcomes.

Over the last two decades, Roche has worked with over 200 pharmaceutical and biotechnology companies to deliver companion diagnostic tests that help enable greater patient access to novel cancer drugs. As a pioneer in personalized healthcare, we offer a leading-edge menu that helps connect patients with more innovative and targeted therapies, across more cancers, than any other IHC/ISH provider.1

Seamlessly integrated with the Roche pathology lab solution, our companion diagnostic portfolio leverages the latest in digital pathology and artificial intelligence (AI)-enabled image analysis technology. Together with our leadership in staining automation, lab integration, and digitization, we empower pathology labs to break down the barriers they face every day and accelerate their path to success.

Pioneering solutions that make it possible for our partners to accelerate the delivery of life-changing treatments to patients

To ensure more patients get the right treatment at the right time, clinicians, labs, and pathologists trust Roche to help them enable personalized healthcare through our market-leading portfolio of high medical value IHC/ISH assays, including companion diagnostics (CDx). Our fully optimized assay system combined with a rigorous development discipline sets us apart among laboratories and pathologists who rely on Roche quality to deliver critical, actionable insights.3

Our expertise and proven track record of success in launching companion diagnostics globally over nearly 25 years has established us as the diagnostic partner of choice for pharmaceutical companies bringing innovative new therapies to patients.

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Benefits of IHC/ISH companion diagnostic solutions from Roche

Enabling personalized healthcare through our industry-leading portfolio

  • Largest menu of IHC/ISH companion diagnostics across several cancers, with the most therapies on label1
  • Strong pipeline of high medical value assays
  • Collaborations with 18 of the top 20 pharmaceutical companies2
  • Empowering clinicians with the information they need to make confident, timely therapeutic decisions
  • Delivering economic value to healthcare systems, payers, and society

Delivering diagnostic certainty with standardized, fully automated tests, education, and support

  • Ready-to-use assays designed to enable timely, reproducible results, backed by deep medical and scientific rigor and stringent development protocols
  • Extensive portfolio includes digital pathology AI-enabled image analysis algorithms to enable fast, accurate interpretation, even remotely
  • Comprehensive education and training dedicated to helping pathologists stay at the forefront of diagnostics and deliver confident assay interpretation
  • First-rate customer service delivered by a global network of dedicated experts to support labs in breaking through barriers and achieving new levels of success

Driving better patient care with the highest quality assays

  • Highly reliable and reproducible results for laboratories thanks to our deliberate and thorough approach to assay development methods and experienced perspectives
  • Consistent delivery of clinical and economic benefits, ensured by our uncompromising commitment to scientific innovation, bringing together broad medical and functional expertise
  • Seamless compliance for your lab achieved through our deep investment in standardization, clinical validation, and regulatory leadership

Enisa’s story: Elevating hope in HER2-low breast cancer

Roche companion diagnostics are helping to improve outcomes for patients like Enisa Besic. Thanks to groundbreaking innovation in precision therapeutics and biomarker testing, Enisa was eligible for a new treatment to combat what’s known as human epidermal growth factor receptor 2 (HER2)-low breast cancer. Hear her speak about her personal journey.

Enisa’s story: Elevating hope in HER2-low breast cancer
Two pathologists wearing lab coats look at a computer screen and are smiling.

Educational tools to support pathologists

We are dedicated to helping pathologists stay at the forefront of diagnostics and advancing their skills through comprehensive education and training. We offer a suite of tools developed by our in-house pathologists, including online courses and videos to aid in the interpretation of our assays.

Laboratory technician at work in the laboratory.

#1 provider of companion diagnostics, global partner of choice

We believe that precision medicine can radically improve lives. That’s why we focus on delivering solutions to advance your therapeutic pipeline at every stage. Roche has worked with 200 biopharma companies to develop and commercialize tests that help enable patient access to novel cancer drugs.

Contact us

Do you have questions about our products or services? We’re here to help. Contact a Roche representative in your region.

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References:

  1. Roche Diagnostics Ltd. Data on file.
  2. Dunleavy K. The top 20 pharma companies by 2022 revenue. Fierce Pharma. [Internet; cited 2024 June 18]. Available from: https://www.fiercepharma.com/pharma/top-20-pharma-companies-2022-revenue.
  3. Maia Strategy Group. Roche Tissue Diagnostics Advanced Staining II: Survey, Double Blinded. Data on file.