Roche launches new highly-sensitive test to more easily diagnose patients who may have B-cell lymphoma
20 June 2024 - 3:00PM
UK Regulatory
Roche launches new highly-sensitive test to more easily diagnose
patients who may have B-cell lymphoma
- The VENTANA Kappa and
Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically
approved in-situ hybridisation (ISH) test with the sensitivity to
assess the full spectrum of B-cell lymphoma
subtypes.1,2
- The test helps
differentiate a B-cell cancer from a normal, reactive immune
response, providing diagnostic certainty for healthcare providers
and their patients.
- B-cell lymphoma accounts
for approximately 85 percent of non-Hodgkin lymphoma (NHL) cases,
which is the tenth most common cancer
worldwide.3
Basel, 20 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today the launch of the first clinically approved,
highly-sensitive in-situ hybridisation (ISH) test, the
VENTANA® Kappa and Lambda Dual ISH mRNA Probe
Cocktail assay, in countries accepting the CE Mark. The test is
designed to help pathologists differentiate a B-cell malignancy
from a normal, reactive response to an infection.4
B-cell lymphoma is a type of cancer that typically develops in
the lymphatic system. It accounts for approximately 85 percent of
non-Hodgkin lymphoma (NHL) cases. NHL is the tenth most common
cancer worldwide and each year more than 250,000 people die from
this disease.3 In the early stages of NHL, patients may
experience symptoms like swelling of the lymph nodes, fever,
fatigue, loss of appetite or a red rash.
“It’s important to be able to provide patients with a definitive
diagnosis as symptoms of lymphoma can appear similar to the body’s
normal reactive response to an infection,” said Matt Sause, CEO of
Roche Diagnostics. “This highly sensitive assay offers diagnostic
certainty for patients with suspected B-cell lymphoma.”
With increased sensitivity, the new test enables assessment
across the more than 60 B-cell lymphoma subtypes and plasma cell
neoplasms on a single tissue slide. The test can assess small
biopsies and formalin-fixed tissue, reducing the need for a fresh
tissue sample, which may not be available especially if lymphoma
was not originally suspected. These test properties preserve
tissue, may result in fewer additional patient biopsies and make
interpretation quicker and easier for the pathologist, helping
create a faster diagnosis and access to treatment for patients.
This first-of-its-kind assay is a significant addition to
Roche’s industry-leading hematopathology portfolio, which includes
more than 65 biomarkers.
About the VENTANA Kappa and Lambda Dual ISH mRNA Probe
Cocktail
VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is intended
for the qualitative detection of Kappa mRNA and Lambda mRNA in
formalin-fixed, paraffin-embedded (FFPE) human bone marrow and
lymphoid tissue stained on a BenchMark IHC/ISH instrument using
chromogenic in-situ hybridisation (ISH) and visualised using light
microscopy. VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail
is intended as an aid in the identification of B-cell lymphomas and
plasma cell neoplasms. The results of the assay should be
interpreted by a qualified pathologist in conjunction with
histological examination, relevant clinical information, and proper
controls. This product is intended for in vitro diagnostic (IVD)
use.4
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.
References
[1] Rimsza LM, et al. Kappa and lambda light chain mRNA in situ
hybridization compared to flow cytometry and immunohistochemistry
in B cell lymphomas. Diagn Pathol. 2014;9:144.
[2] F. Hoffmann-La Roche Ltd. Conjoint Market Research. [Survey;
Cited 2024 April 4]. Data on File.
[3] Global Cancer Observatory. Non-Hodgkin Lymphoma Fact Sheet
[Internet; Cited 11 April 2024]. Available from:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf
[4] F. Hoffmann-La Roche Ltd. VENTANA Kappa and Lambda Dual ISH
mRNA Probe Cocktail. [Method Sheet; cited 2024 April 16]. Data on
file.
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