Hamilton Thorne Biosciences Announces Significant Breakthrough for Rolling Circle Amplification.

BEVERLY, Mass. -- Hamilton Thorne Biosciences, Inc. today announced a major breakthrough that should lead to an explosion in the applications of rolling circle amplification (RCA) of nucleic acids in a wide range of diagnostic markets. Hamilton Thorne's R&D group, led by Vice President David J. Lane, Ph.D., made this crucial discovery, which results in up to a 10-fold increase in successful DNA circle replication over commercially synthesized circle probes.

Many researchers have stated that RCA will provide an effective alternative to Polymerase Chain Reaction (PCR) amplification for many molecular diagnostic markets where the cumbersome intricacies of PCR seem to limit entry into those segments. "We believe that our patent-pending breakthrough will provide the robustness and reproducibility that have been lacking in previous attempts to provide a cost-effective alternative to PCR testing for molecular diagnostics," said Harry G. McCoy, Pharm.D., President of Hamilton Thorne Biosciences, Inc. Dr. McCoy went on to say, "Markets that will benefit from this new technology include field testing for household mold, monitoring spoilage in grain elevators, and clinical diagnostics in small hospitals, large clinics, and regional clinical laboratories. This innovation is yet another reinforcement of Hamilton Thorne's dominant position in rolling circle amplification."

RCA refers to a method for amplifying DNA or RNA in which an oligonucleotide primer complementary to a circle of single-stranded DNA is extended "endlessly." This amplification is accomplished through use of a DNA polymerase (e.g., phi 29) which "rolls" around the circle displacing the previously produced product strand ahead of the replication point. Efficient replication of DNA from pre-formed circles or from circles created as an initial step in the assay is critical to the success of RCA-based diagnostics. However, with experience, it has become apparent that only a relatively small fraction of commercially synthesized circle probes actually are able to replicate. Dr. Lane estimates that only 10-30%, and much less for some manufacturing lots, of highly purified circles from commercial sources can replicate.

While the cause of this deficiency is currently unknown, Dr. Lane stated, "We hypothesized that it was due to some intrinsic, but low-level consequence of the synthetic chemistry used to produce commercial circles. Results from our lab suggest that this is indeed true; circles produced by a novel enzymatic process developed at Hamilton Thorne replicate up to10-fold better than chemically produced circles. We believe that this represents a significant technical breakthrough in the development of RCA-based diagnostic assays."

Hamilton Thorne Biosciences is a privately held DNA technology and automated instrumentation company with a focus on the detection and quantification of proteins and nucleic acids. Additional information about Hamilton Thorne Biosciences and its technologies is available at www.hamiltonthorne.com.