RainDance Publication Demonstrates Non-Invasive Metastatic Colorectal Cancer Detection by Liquid Biopsy using Digital PCR

  RainDance Publication Demonstrates Non-Invasive Metastatic Colorectal Cancer
  Detection by Liquid Biopsy using Digital PCR

Publication in Journal of Clinical Chemistry demonstrates how RainDance’s
digital PCR technology unlocks unprecedented sensitivity and quantitative
detection of multiple KRAS mutations directly from plasma of patients with
metastatic colorectal cancer.

Business Wire

BILLERICA, Mass. -- September 11, 2013

RainDance Technologies, Inc., the Digital Biology™ Company, announced a
publication demonstrating the use of the company’s digital PCR technology for
detecting mutations in circulating tumor DNA directly from blood samples. The
paper, co-authored by a consortium of research clinicians in France and
RainDance scientists, highlights the significant value unlocked by the
company’s digital PCR platform for non-invasive monitoring of multiple cancer
mutations obtained from a simple blood draw, as an alternative to invasive
tissue biopsy.

The publication, entitled “Multiplex picodroplet digital PCR to detect KRAS
mutations in circulating DNA from plasma of colorectal cancer patients,” was
published online in the journal Clinical Chemistry on August 12, 2013.

The research was led by clinicians from the Université Paris Sorbonne Cité,
HôpitalEuropéenGeorges Pompidou, Hôpital Robert Debré, in collaboration with
scientists from the University of Strasbourg and RainDance. The authors
reported the results of screening 50 plasma samples from patients with
metastatic colorectal cancer for seven of the most common mutations in codons
12 and 13 of the KRAS oncogene. Results from multiplexed digital PCR on these
plasma samples were compared to qPCR results from DNA taken from a biopsy of
the primary tumor, demonstrating the capability of detecting these actionable
cancer mutations in an easily accessible blood sample.

“The current sensitivity threshold for mutation detection in clinical practice
is approximately 1%, but we know that levels of circulating tumor DNA may be
0.01% or lower,” said Dr. Valerie Taly, group leader at the Université Paris
Sorbonne Cité and lead author on the paper. “With the performance we have seen
using picoliter droplet digital PCR, it is now easy to imagine moving toward
non-invasive liquid biopsies for specific mutation detection in a clinical
setting. We have purchased our first commercial RainDrop™ Digital PCR system
in order to work towards this goal.”

Further, regarding the results obtained, fellow author and oncologist Pierre
Laurent-Puig, MD, Ph.D., noted “It is not important to say ‘yes’ or ‘no’, what
is important is to say the quantification, and then to develop a threshold
that has relevance for patients with cancer.”

The RainDrop Digital PCR System is a breakthrough research platform that is
transforming molecular analysis by enabling digital answers across a number of
applications. Today’s announcement follows other recent published customer
successes: last month, scientists from the Massachusetts General Hospital
demonstrated the use of a RainDrop Digital PCR System to detect
glioma-associated mRNA mutations from cerebrospinal fluid (CSF); also,
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.

“We are seeing the emergence of novel cancer applications which reflects the
transformative potential of digital PCR. This publication highlights the
tremendous value of our RainDrop Digital PCR System in enabling cancer
research,” said Darren Link, Ph.D., Chief Technology Officer at RainDance.
“Our goal is to provide researchers and eventually clinicians with new tools
to help detect mutations that will not require putting patients through
countless painful, and often, dangerous procedures.”

For a complete list of RainDrop Digital PCR System publications, please visit

About RainDance Technologies

RainDance Technologies is a leading life sciences company developing
innovative products that enable more accurate, reliable, cost-effective and
early detection of disease and predisposition risk in order to improve human
healthcare. Today, RainDance is focused on better healthcare outcomes and
lowering costs for the research, diagnosis 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 Digital
Biology are trademarks of RainDance Technologies, Inc. All other brands may be
trademarks of their respective holders.


BlueChair Group
Pamela Mahoney, 408-674-6997
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