RainDance RainDrop™ System Proven to be Industry’s Most Precise Digital PCR Platform for Measuring Chromosomal Copy Number

  RainDance RainDrop™ System Proven to be Industry’s Most Precise Digital PCR
  Platform for Measuring Chromosomal Copy Number Variation

Company presents results demonstrating accurate detection of small chromosomal
  differences at CNAPS VIII Conference and showcases technology at AMP 2013
                                Annual Meeting

CNAPS VIII Conference 2013 AMP 2013 Annual Meeting

Business Wire

BILLERICA, Mass. -- November 13, 2013

RainDance Technologies, Inc. todayannounced that it has added a
High-Precision Chromosomal Copy Number Variation (CNV) Measurement application
to its industry-leading RainDrop™ Digital PCR System. The latest application
provides researchers with a simple and highly accurate method of detecting low
frequency chromosomal CNVs and trisomy events from circulating tumor cells or
cell-free DNA. Recent studies have demonstrated the RainDrop System’s ability
to detect CNVs with greater than 99 percent confidence when the sample makes
up as low as five percent of the 10 nanograms input DNA. The High-Precision
CNV application utilizes universal probe designs and is being made available
immediately to all current and future RainDrop customers.

Variation in chromosomal number can occur in genetic disease and cancer tumor
progression. However, the fraction of the cells affected by chromosomal
abnormalities may only be a small portion of the sample material, making it
very difficult to quantify chromosomal CNVs. Additionally, there may be as
little as 10ng of highly fragmented material available for the analysis. The
RainDrop System overcomes these barriers and enables users to precisely
measure these types of chromosomal copy number differences. Customers have
approached RainDance to use this High-Precision CNV Measurement method for a
range of applications, including detecting circulating tumor cells and
cytogenetics.

“The new High-Precision CNV Measurement application makes the RainDrop System
the industry’s most versatile genomic analysis platform and most precise
Digital PCR platform for measuring chromosomal changes from samples such as
circulating tumor cells or cell-free DNA,” said Darren R. Link, Ph.D.,
Co-founder and Chief Technology Officer at RainDance Technologies. “We were
able to prove that a tiled multi-locus assay using a universal configuration
can accurately detect some of the most challenging CNVs associated with
aneuploidy and cancer tumor progression.”

Transforming Traditional CNV Studies

The RainDrop System is the industry’s most precise digital PCR platform for
accurately detecting and measuring low frequency chromosomal changes. During
the CNAPS Conference, experimental data was presented demonstrating successful
performance of:

  *A 40-plex assay design: The team co-amplified 40 unique primer-probe
    regions over two different chromosomes using a universal probe design.
  *Wide range of input requirements: Total system precision was assessed by
    successfully detecting CNVs at various input amounts of DNA ranging from
    50ng to 10ng.
  *Increasing amounts of affected fraction: The team observed clear
    separation between normal and affected chromosomal CNVs where affected DNA
    was five percent the total DNA population/fraction.
  *Industry’s lowest coefficient of variation (CV): The RainDrop System  CV
    was demonstrated to be less than 0.5 percent.

Platform Versatility

The RainDrop Digital PCR System is transforming molecular analysis by enabling
digital answers across a number of other applications. The company recently
launched One-Step RT-dPCR capabilities, which provide researchers with a
simple method of counting individual RNA target molecules. Today’s
announcement also follows other recent published customer successes:

  *Publication in Journal of Clinical Chemistry demonstrated the use of the
    RainDrop Digital PCR system to detect multiple KRAS mutations directly
    from a liquid biopsy.
  *Scientists from the Massachusetts General Hospital demonstrated the use of
    a RainDrop Digital PCR System to detect glioma-associated mRNA mutations
    from cerebrospinal fluid.
  *Trovagene Inc. recently demonstrated that BRAF mutations present in
    trans-renal DNA from urine can be measured with unprecedented sensitivity
    by the RainDrop Digital PCR System.

For a complete list of RainDrop Digital PCR System publications, please visit
RainDanceTech.com/Publications.

Upcoming Technology Demonstrations and Recent Public Presentations

RainDance will be showcasing the RainDrop Digital PCR System in Booth 206 at
the AMP 2013 Annual Meeting in Phoenix, AZ on November 14-16, 2013. In
addition, Dr. Darren Link presented the latest data supporting the
High-Precision CNV Measurement application during the recent Circulating
Nucleic Acids in Plasma and Serum Conference in Baltimore, MD. For more
information, on the RainDrop System and the applications, please visit
http://raindancetech.com/digital-pcr-tech.

About RainDance Technologies

RainDance Technologies is an emerging life sciences company developing
innovative products that enable more accurate, reliable, cost-effective and
early detection of disease and risk predisposition in order to improve human
healthcare. Today, RainDance is focused on better healthcare outcomes and
lowering costs for the research, detection and treatment of cancers and
inherited diseases. The company’s innovative RainStorm™ digital droplet
technology powers next-generation sequencing and genetic testing systems that
deliver dramatically superior performance, cost, interpretability, and ease of
use. RainDance systems are used routinely in major academic research
institutions, clinical genetics laboratories, and hospitals around the world.
Based in Billerica, Massachusetts, the company supports customers through its
international sales and service operations as well as a global network of
distributors and commercial service providers. For more information, please
visit www.RainDanceTech.com.

The RainDrop Digital PCR System is for Research Use Only; not for use in
diagnostic procedures.

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

Contact:

RainDance Technologies, Inc.
Andrew Noble, 415-722-2129
noblea@RainDanceTech.com
 
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