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Independent Study Validates Bio-Rad Laboratories, Inc. (BIO)'s Droplet Digital™ PCR Technology for Analyzing Archival Cancer Samples


12/12/2012 3:09:52 PM

Hercules, CA — December 12, 2012 — The Ji Research Group at Stanford University, in collaboration with Bio-Rad’s Digital Biology Center demonstrated that the QX100™ Droplet Digital PCR (ddPCR™) system enables accurate and precise measurements of cancer genome amplifications in archival cancer tissue samples. The results of their study were published online in Translational Medicine

“The cancer research community is greatly interested in accurately identifying and characterizing genome amplifications and other copy number variations because they are a critical component for understanding and treating human cancers,” said Dr. Hanlee Ji, MD, director of the Ji Research Group. “Using ddPCR, we demonstrated the superiority of this method for copy number analysis of DNA in archival material.”

Certain copy number variations (CNVs) known as genomic amplifications may lead to overexpression of specific oncogenes that drive cancer development. Targeting amplified oncogenes could move us closer to long-sought personalized therapies for cancer treatment.

Detecting amplifications in cancer tissue is technically challenging for two reasons. One is that normal tissue is known to dilute the presence of genomic amplifications. The other is that clinical samples are typically of poor quality because they are traditionally processed as formalin-fixed, paraffin-embedded (FFPE) tissues. This preservation method leads to irreversible damage to the genomic DNA. More sensitive methods of evaluation are thus needed to overcome the poor DNA quality found in FFPE samples and to detect small fractions of tumor DNA.

Bio-Rad’s QX100 system partitions samples into 20,000 droplets for individual PCR reactions. This partitioning reduces background interference and provides a more reliable measurement of a target sequence within a complex sample. As a result, measurement precision is less affected by suboptimal PCR conditions in FFPE samples than when less sensitive methods are used. 

Research Findings

Dr. Ji and Digital Biology Center researchers tested the QX100 system to determine its effectiveness in detecting cancer gene amplifications in FFPE cancer tissue samples. They diluted gastric cancer genomic DNA containing an FGFR2gene amplification in decreasing ratios with DNA from a normal genome sample. Their analysis confirmed the accuracy, reproducibility, and sensitivity of ddPCR in quantifying the FGFR2-amplified gene even when there was a 1,000-fold dilution with normal genome DNA.

The researchers then compared qPCR and ddPCR methods for measuring FGFR2 gene amplifications. They confirmed the presence of an approximately sevenfold amplification of the FGFR2 locus in an FFPE-processed gastric tumor using ddPCR. That amplification was very similar to the value determined using a microarray analysis on a “matched” flash-frozen sample. In contrast, qPCR analysis of the same FFPE tumor sample found a copy number estimate of 35, demonstrating that ddPCR is more accurate than qPCR for determining copy number variants in these FFPE-derived samples. 

“We were able to demonstrate that ddPCR provides the sensitivity needed to detect genomic amplifications in archival material,” said Dr. Ji. “Now we can conduct a variety of genomic studies using the QX100 system that could not have been done using traditional methods, such as real-time PCR.”

For further details about the QX100, please visit http://bit.ly/ddPCR_QX100

About Bio-Rad

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) has remained at the center of scientific discovery for more than 50 years, manufacturing and distributing a broad range of products for the life science research and clinical diagnostic markets. The Company is renowned worldwide among hospitals, universities, major research institutions, as well as biotechnology and pharmaceutical companies for its commitment to quality and customer service. Founded in 1952, Bio-Rad is headquartered in Hercules, California, and serves more than 100,000 research and industry customers worldwide through its global network of operations. The company employs over 7,100 people globally and had revenues exceeding $2 billion in 2011. For more information, visit www.bio-rad.com

This release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally can be identified by the use of forward-looking terminology such as, “believe,” “expect,” “may,” “will,” “intend,” “estimate,” “continue,” or similar expressions or the negative of those terms or expressions. Such statements involve risks anduncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. For further information regarding the Company's risks and uncertainties, please refer to the “Risk Factors” in the Company’s public reports filed with the Securities and Exchange Commission, including the Company’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company cautions you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. Bio-Rad Laboratories, Inc., disclaims any obligation to update these forward-looking statements.

For more information contact:

Richard Kurtz

Bio-Rad

510-741-5638

Richard_Kurtz@bio-rad.com

Ken Li

Chempetitive Group

312-997-2436 x 112

kli@chempetitive.com



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