Blood cancers (hematologic malignancies)

Hematologic malignancies (lymphoma, leukemia, and multiple myeloma) are among the most common cancers globally, accounting for 1.3 million cases in 2019.⁴ Non-hodgkin’s lymphoma (NHL) is the most common lymphoma, accounting for 90% of lymphoma cases.⁵ Annually, there are over 550,000 NHL cases and 250,000 deaths, making it the 11th leading cause of cancer-related death.⁶

The 5-year overall survival rate for NHL patients is approximately 60%.⁷ However, relapse can be high. For example, in diffuse large B-cell lymphoma (DLBCL), the most common subtype of NHL, the relapse rate within the first two years of achieving remission after treatment is 50-60%.⁸

In the US, annual healthcare expenditure for each NHL patient is over $USD 21,000, significantly higher than other cancer groups.⁹

Lymphomas are heterogeneous at the clinical, morphological, and molecular levels, and have overlapping features – leading to the fragmentation of the diagnostic pathway.¹⁰

There is a diverse range of lymphoma subtypes and each falling under broader guidelines that recommend different testing and treatment modalities. For example, the National Comprehensive Cancer Network (NCCN) has several distinct guidelines for different hematologic malignancies, underlying the complexity of this group of diseases.¹¹ On top of this, the Royal College of Pathologists recommends different sets of IHC markers and panels for different subtypes and diagnostic settings.¹²

According to the International Consensus Classification of Mature Lymphoid Neoplasms, there are multiple subcategories for mature B-cell neoplasm, classic Hodgkin lymphoma, and mature T-cell and NK-cell neoplasm.¹³ Furthermore, although DLBCL is the most common subtype of NHL, it often presents diagnostic challenges due to its diverse clinical presentation.¹⁴

Also, lymphomas require a comparatively higher number of diagnostic markers than other cancer types.^7,15 The World Health Organization (WHO) classification of lymphoid tumors and recommended diagnostic tests continue to expand with diagnostic algorithms differing by category, family, entity, and subtype.¹⁶

As a partner with an established focus on pathology and a proven track record for excellence, Roche’s comprehensive solutions address the growing need for precise typing and subtyping, driven by evolving guidelines and cutting-edge molecular techniques.

Roche provides a comprehensive portfolio of solutions for blood cancers (hematologic malignancies) across the patient journey, empowering clinicians to make timely and confident decisions that drive better patient outcomes.

Diagnosis, typing, and subtyping: Roche offers a broad menu of hematopathology assays tailored for a variety of clinical needs. Specifically, the VENTANA Kappa and Lambda Dual ISH assay is designed to deliver multiple clinical benefits over the existing methodologies.²⁰

Identifying potential targeted therapy options: Companion diagnostics are crucial as they identify specific genetic mutations and provide comprehensive genomic profiles, enabling personalized and effective treatment plans. For example:

• The cobas® EZH2 CDx assay is a real-time, allele-specific polymerase chain reaction (PCR) test that has been approved for the identification of follicular lymphoma patients with an EZH2 mutation for treatment with TAZVERIK™ (tazemetostat), in accordance with the approved therapeutic product labeling.^22,23
• The FoundationOne® Heme Panel** is a comprehensive genomic profiling (CGP) test combining DNA and RNA sequencing for patients with hematologic malignancies, sarcomas, or solid tumors where RNA sequencing is desired. This CE-IVD test can be used by physicians to identify potential targeted therapy options, detect alterations in prognostic genes, and sub-classify sarcoma diagnoses.^24,25

Our solutions are designed to elevate laboratory efficiency, safety, and standardization through market-leading, fully automated instruments and workflow solutions:

• Proven track record: 100 million IHC and ISH slides stained annually on BenchMark systems worldwide, backed by over 40 years of experience and nine generations of innovation.
• Efficiency improvement through digital solutions: Monitoring impactful clinical operations efficiencies with digital solutions (e.g. nearly 3 times more molecular reports per hour using navify® Clinical Hub for Mutation Profiler).²⁷
• Enhanced clinical decision-making: With navify Clinical Hub, we enhance clinical decision-making by offering digitized oncology guidelines, clinical trial matching, and publication search capabilities. This empowers healthcare providers to make more personalized and evidence-based care decisions throughout the patient's care journey.²⁸

By taking a collaborative approach with our partners and customers, Roche’s expertise provides enduring support for your practice. Our business model focuses on:

• Engaging with professional societies and experts to advance independent lymphoma research and sponsor educational programs²⁹
• Collaborating with researchers to develop new technologies that can improve lymphoma diagnosis²⁰
• Demonstrating ongoing innovation by investing in cutting-edge diagnostics with continuous growth in R&D investments³⁰