BILLERICA, Mass — 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, Hôpital Européen Georges 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.”