* 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 (http://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.
Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
(mailto:media.relations@roche.com)

  Hans Trees, PhD           Sileia Urech
  Phone: +41 79 407 72 58   Phone: +41 79 935 81 48
  Nathalie Altermatt        Simon Goldsborough
  Phone: +41 79 771 05 25   Phone: +44 797 32 72 915
  Karsten Kleine            Nina Mählitz
  Phone: +41 79 461 86 83   Phone: +41 79 327 54 74
  Kirti Pandey              Yvette Petillon
  Phone: +49 172 6367262    Phone: +41 79 961 92 50
  Dr. Rebekka Schnell
  Phone: +41 79 205 27 03

Roche Investor Relations

 Dr. Bruno Eschli                        Dr. Sabine Borngräber
 Phone: +41 61 68-75284                  Phone: +41 61 68-88027
 e-mail: bruno.eschli@roche.com          e-mail: sabine.borngraeber@roche.com
 (mailto:bruno.eschli@roche.com)         (mailto:sabine.borngraeber@roche.com)
                                          (mailto:sabine.borngraeber@roche.com)

Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
(mailto:birgit.masjost@roche.com)
Investor Relations North America

  Loren Kalm
  Phone: +1 650 225 3217
  e-mail: kalm.loren@gene.com (mailto:kalm.loren@gene.com)

Â