[December 06, 2012]

MLL Munich Leukemia Laboratory Pairs RainDance ThunderStormTM System with Illumina MiSeq™ for Acute Myeloid Leukemia Sequencing

RainDance Technologies, Inc., the Digital Biology™ Company, and the MLL Munich Leukemia Laboratory (MLL) today announced that MLL will be releasing data for a new myeloid hematological malignancies gene panel generated using RainDance Technologies' ThunderStorm™ System coupled with Illumina's MiSeq™ platform. MLL will present initial results from a technology evaluation and research study at the 54th Annual American Society of Hematology (ASH) meeting next week in Atlanta.

MLL has developed a comprehensive, 31-gene deep-sequencing panel to identify both favorable and adverse molecular markers for the subclassification of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS). This panel uses RainDance's unique picodroplet single-molecule PCR (News - Alert) enrichment solution and 2 x 250bp paired-end reads generated on the Illumina MiSeq instrument. This panel also features RainDance's DirectSeq™ tailed primer workflow, which incorporates sequencing adapters in the primers and unique barcodes via a secondary PCR, thereby eliminating sequencing library construction and enabling 4-5 samples to be analyzed per MiSeq run. To date, MLL has processed more than 200 samples using the RainDance ThunderStorm System to identify prognostically relevant mutations for AML and other myeloid malignancies. MLL intends to use 2 x 250bp paired-end reads for this panel later in its commercial operations.

"The number of molecular markers used to characterize myeloid malignancies such as AML is constantly increasing. There is an acute unmet need to test significantly larger gene panels while increasing sensitivity and coverage by orders of magnitude," said Prof. Dr. Dr. Torsten Haferlach, CEO of MLL. "By coupling the MiSeq platform with RainDance's ThunderStorm System, we have developed the industry's leading panel to analyze clinically relevant genes for AML and MDS using high-throughput targeted sequencing. We have standardized onto the RainDance-Illumina workflow to generate unparalleled data that can be used to classify patients battling myeloid malignancies."

Data presented at the meeting will highlight a recent technology evaluation and research study, where MLL analyzed 49 well-annotated patients harboring myeloid malignancies. The targeted gene panel library was constructed using RainDance's proprietary primer design pipeline and sequenced using the Illumina MiSeq platform. The coverage per amplicon was 2,095-fold, thus enabling highly sensitive detection of variants. Total turn-around time from sample to result was less than fou days.

"MLL is one of several marquee research customers adopting our ThunderStorm system and proven droplet-based PCR enrichment solution to generate 100 percent genomic target coverage, completeness and heterozygous concordance. Our system provides a highly simplified workflow, high-throughput walkaway automation, and cost efficiencies in sample prep, sequencing and informatics significantly better than any other commercial solution," said Andy Watson, Chief Marketing Officer of RainDance Technologies. "We are pleased to have MLL as our customer and believe their AML/MDS panel will enable translational researchers to better characterize life-threatening cancers."

Researchers from MLL will be discussing these and other data at the annual meeting of the American Society of Hematology (ASH) in Atlanta, December 8-11. These presentations include:

• Saturday, December 8 at 7:30am and 2:00pm ET: Next Generation Sequencing: Should it Become Part of Routine Diagnostics for Leukemias and Other Myeloid Neoplasms In this talk, Prof. Dr. Dr. Haferlach will discuss the application of deep sequencing and the insights it has provided for both leukemias and other myeloid neoplasms as well as the translation of recent discoveries into state-of-the-art gene screening assays.
• Monday, December 10 at 10:30am ET: Results of a Comprehensive Next-Generation Sequencing Study Analyzing 32 Genes. In this presentation, Dr. Wolfgang Kern (MLL) will discuss data from a study of the molecular and cytogenetic characterization of MPAL-TM in comparison of AML and T-ALL using a 32-gene screening panel.
• Tuesday, December 11 at 7:30am ET: First Results of a 31-Gene Panel Targeted to Investigate Myeloid Malignancies by Next-Generation Amplicon Deep-Sequencing. In this presentation, Dr. Alexander Kohlmann (MLL) will discuss the use of RainDance's sequence enrichment solution and Illumina's MiSeq instrument to develop a novel 31-gene assay for myeloid malignancies.

For more information about the ASH meeting and these presentations, please visit: www.hematology.org.

Dr. Kohlmann will also discuss data from the new myeloid malignancies gene panel during a live RainDance-sponsored webinar, Thursday, December 13 at 11:00am ET. For more information and to register for this free webinar, please visit: www.RainDanceTech.com/MLL-Webinar.

For more information about RainDance Technologies, please visit: www.RainDanceTech.com. For more information about MLL, please visit: www.MLL.com.

About RainDance Technologies

RainDance Technologies, the Digital Biology™ Company, is pioneering the use of high-throughput picodroplet-based analysis in human health and life science research. The company's core RainStorm™ technology generates millions of discrete droplets that can encapsulate a single molecule, cell or reaction and be digitally analyzed and sorted one at a time. The power, precision and simplicity of picodroplets enable researchers to answer complex questions with unprecedented sensitivity and quantitation. The complete RainDance solution includes automated instrumentation, customizable bioinformatics and high-value consumables and reagents for applications including targeted next-generation DNA sequencing, methylation, digital PCR. Based in Lexington, Massachusetts, the company supports scientists around the world through its international sales and support operations and a global network of distributors and service providers. For more information, please visit www.RainDanceTech.com.

For Research Use Only. Not for use in diagnostics procedures.

RainDance Technologies, the RainDance Technologies logo, ThunderStorm, RainStorm, DirectSeq, and Digital Biology are trademarks of RainDance Technologies, Inc. All other brands may be trademarks of their respective holders.

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