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Digital PCR Pioneer Chooses Bio-Rad Laboratories, Inc. (BIO)'s QX100™ Droplet Digital™ PCR System to Develop Leukemia Test


1/8/2013 11:38:23 AM

Hercules, CA — January 4, 2013 — Professor Alec Morley, a pioneer in digital PCR, has chosen Bio-Rad Laboratories’ QX100 Droplet Digital PCR system to develop a diagnostic test for chronic myeloid leukemia (CML).

In 1992, Prof. Morley and his lab at Flinders University and Medical Center in Adelaide, South Australia, published a general method called “limiting dilution PCR” for quantifying PCR targets. As a proof of concept, they used this method for the quantification of marker mutations in acute leukemia. By diluting DNA samples so that only one or two copies per well were present and then amplifying those copies with PCR, Morley’s team was able to detect two copies of leukemic DNA against a background of 160,000 normal genomes.

They subsequently reported in The Lancet that the outcome of acute leukemia can be predicted by measuring the response to treatment using limiting dilution PCR to quantify the leukemic cells at high sensitivity. In later work, the Morley Lab used real-time quantitative PCR (qPCR) to develop a highly sensitive method for isolating and quantifying the chromosomal translocation that is typically associated with CML.

Using droplet digital PCR to diagnose leukemia

Because the translocation point for each patient is different in CML, real-time PCR conditions may vary from patient to patient and may therefore produce different results. The lab has now returned to digital PCR.

“Advancements in digital PCR have given us the ability to overcome variations in real-time PCR amplification efficiency and have also enabled us to do away with using a standard curve,” Prof. Morley said.

Monoquant, a company associated with Flinders University, recently used Bio-Rad’s QX100 system to refine the new clinical test for CML. Not only does the instrument offer high sensitivity, it also removes variability in amplification efficiency that results from using patient-specific PCR primers, a traditional sticking point for the FDA. Monoquant hopes the results from the QX100 system will fast-track the FDA approval process for its test.

“It’s a great feeling knowing that something we helped create is propelling our work today,” Prof. Morley said. “We are hoping that this new test we’re developing will offer a better degree of monitoring and better disease management for patients by tracking the progression or remission of CML.”

About Monoquant

Monoquant was formed in 2002 by Flinders University and researchers in the Morley Lab to advance commercial applications developed by the group. The company has applied for several patents related to both new variations of PCR and the application of PCR to laboratory diagnosis, and has licensed its intellectual property in the area of hematopathology to companies in the US. In addition, the company provides diagnostic methods in acute and chronic leukemia and in measurement of RNA and DNA integrity. For more information, visit http://www.monoquant.com.au.

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 and uncertainties, 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.



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