Roche 454 Sequencing Systems successfully resolve genetic mutations in over 4,000 blood cancer cases

 Roche 454 Sequencing Systems successfully resolve genetic mutations in over
                           4,000 blood cancer cases

  PR Newswire

  PENZBERG, Germany, December 11, 2012

PENZBERG, Germany, December 11, 2012 /PRNewswire/ --

- International study presented at American Society of Hematology Meeting
demonstrates the potential of 454 Sequencing Systems to comprehensively
characterize an individual's blood cancer type to guide personalized therapy

At the American Society of Hematology Meeting (ASH) Roche announced today the
presentation of results from the large scale study IRON-II through an
international research consortium. Based on next generation 454 Sequencing
Systems from Roche, the study aims to characterize selected genes in
individuals with a wide range of hematological malignancies. The consortium of
26 laboratories from 13 countries in Europe and Asia performed comprehensive
analysis of 74 genes in individuals with acute myeloid leukemia (AML), acute
lymphoblastic leukemia (ALL), chronic lymphatic leukemia (CLL), chronic
myelogenous leukemia (CML), myelodysplastic syndromes (MDS), and
myeloproliferative neoplasms (MPN).

The results from over 4,000 cases demonstrate that the highly advanced
technology supports the comprehensive molecular characterization of
hematological malignancies with high sensitivity and specificity, with the
future prospect of guiding more personalized treatment decisions. The study is
one of dozens of abstracts and talks using 454 Sequencing Systems presented at
the ASH meeting this week.

Researchers from the MLL Munich Leukemia Laboratory, pioneering the adoption
of next-generation sequencing to profile blood cancers, are leading the
international consortium. Earlier this year, Roche launched a set of
sequence-based primer sets co-developed with the MLL for deep genetic
variation detection in the TET2 , CBL , KRAS , and RUNX1 genes using the GS
FLX and GS Junior Systems. The current study is an extension of the previous
IRON study which demonstrated the robustness, precision and reproducibility of
next generation sequencing with 454 Sequencing Systems for characterization of
key genes associated with leukemia ^[ ^1 ^] . It broadens the set of genes
from 3 to 74 with a new expanded set of investigative primer plates.

"We are particularly pleased with the performance of the Roche assays in
combination with the high quality long read length of the 454 Sequencing
Systems. This is the only technology that allows us to resolve complex
variations in genes such as RUNX1 or CEBPA and enables us to address questions
such as landmark analyses in various mutated genes in hematological
malignancies and the development of future prognostic models," said Dr.
Alexander Kohlmann, Head of the Next Generation Sequencing Group at the MLL
and coauthor of 28 studies presented at this year's conference. "One key
aspect of the IRON-II study is that we now achieved to standardize gene
content via amplicon-based deep-sequencing assays across hematological expert
laboratories, including the bioinformatic analysis approaches."

In addition to the consortium results, the MLL Munich Leukemia Laboratory
presented novel sequencing data on various disease types including the role of
TP53 and CEBPA mutations in AML, or SF3B1 and NOTCH1 mutations in CLL.

"By applying this novel technology we are now in a position to challenge
existing schemes for classification and scoring," said Prof. Torsten
Haferlach, cofounder and CEO of the MLL. "We can begin to integrate molecular
information into more biologically driven models. Ultimately, this could allow
us to individualize our approach to treat our patients."

"We are pleased with the results of the international study, which continues
to evaluate the unique value of 454 Sequencing Systems in blood cancer
research," said Thomas Schinecker, President of 454 Life Sciences, a Roche
Company. "We are strongly supporting the community with the development of
standardized gene panels for molecular characterization of hematological
malignancies, which is an important step towards future routine clinical use."

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused
healthcare with combined strengths in pharmaceuticals and diagnostics. Roche
is the world's largest biotech company with truly differentiated medicines in
oncology, virology, inflammation, metabolism and CNS. Roche is also the world
leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer
in diabetes management. Roche's personalised healthcare strategy aims at
providing medicines and diagnostic tools that enable tangible improvements in
the health, quality of life and survival of patients. In 2011, Roche had over
80,000 employees worldwide and invested over 8 billion Swiss francs in R&D.
The Group posted sales of 42.5 billion Swiss francs. Genentech, United States,
is a wholly owned member of the Roche Group. Roche has a majority stake in
Chugai Pharmaceutical, Japan. For more information: .

For life science research only. Not for use in diagnostic procedures.

454, 454 LIFE SCIENCES, 454 SEQUENCING and GS FLX are trademarks of Roche .

All other product names and trademarks are the property of their respective

^[ ^1 ^] Kohlmann A et al. 2011. The Interlaboratory RObustness of
Next-generation sequencing (IRON) study: a deep sequencing investigation of
TET2, CBL and KRAS mutations by an international consortium involving 10
laboratories. Leukemia. 25(12):1840-8

For further information please contact: Roche Diagnostics Dr Claudia Schmitt
Phone: +49-8856-60-10210 Email:
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