A highly sensitive and practical alternative amplification method is being developed for use in drug discovery and genetic analysis. Through an agreement between Molecular Staging Inc. and Amersham Pharmacia Biotech, Amersham Pharmacia Biotech has gained exclusive rights to commercialise reagents for all research uses of the new and revolutionary amplification procedure.

This highly innovative technology, called Rolling Circle Amplification, can be used to detect and amplify, routinely and simply, single target molecules such as individual DNA and RNA molecules and indirectly to measure single protein molecules. The two businesses will work together to develop Rolling Circle Amplification for a wide range of applications designed to improve methods of drug discovery and genetic analysis. Molecular Staging will retain its rights to develop Rolling Circle Amplification for clinical diagnostic applications.

Rolling Circle Amplification, which was discovered in 1995 by Dr. Paul Lizardi in the laboratory of Professor David Ward at Yale University School of Medicine, enables target amplification to take place at a constant temperature. This eliminates the need for thermal cycling used in existing methods such as Polymerase Chain Reaction (PCR®). Apart from the remarkable sensitivity for DNA, RNA and protein detection, Rolling Circle Amplification has several other advantages over rival technologies, including increases in amplification efficiency, ability to pinpoint the location of molecules that have been amplified, and ease as well as accuracy of quantitation.

Several aspects of Rolling Circle Amplification make this technology especially valuable in the area of genomics and pharmacogenomics. For example, since the amplified product can remain attached to its template, Rolling Circle Amplification has considerable promise for applications where probe localisation is essential, such as microarrays or in situ hybridisation. In addition, because Rolling Circle Amplification can amplify very long DNA fragments, the technology can also be used in genetic mapping, for cloning in vitro and for preparation of DNA samples for sequencing.

“This exciting and highly innovative new technology will offer scientists a whole new level of detection capability when it comes to discovering and analysing potential new drugs,” said Mike Evans, Amersham Pharmacia Biotech’s vice-president of drug discovery. “Over the next few years, we intend to look at how Rolling Circle Amplification could provide our popular Microarray Technology Access Program with a significant improvement in sensitivity. Other applications could include the development of direct genomic sequencing and tangible improvements to immunoassay methods used in cell biology.”

According to Torben Christensen, Chief Executive Officer of Molecular Staging Inc.: “Molecular Staging is very fortunate to have gained access to Rolling Circle Amplification and other novel technologies developed by Yale scientists. We intend to use these procedures to develop a new generation of ultra-sensitive diagnostic tests. Rolling Circle Amplification provides us with the opportunity to simultaneously target both genes and their products, a significant advance in efforts to characterise the normal and abnormal behaviour of cells. An important aspect of our strategy to effectively exploit this technology is to make it broadly available to academic and industrial scientists alike. We are delighted that Amersham Pharmacia Biotech, a premier life sciences company, has recognised the enormous potential of Rolling Circle Amplification and has chosen to work with us to commercialise research reagents based on this technology.”

Amersham Pharmacia Biotech is a major international biotechniques company; it provides innovative and leading-edge technology solutions to the problems faced by researchers and engineers aiming to discover and produce new drugs and therapies, faster and more cost-effectively than ever before. The market leader in virtually all of its markets, the company’s novel systems are used to sequence DNA, uncover the function of genes and proteins, separate biomolecules, screen potential drugs and manufacture biopharmaceuticals.

Molecular Staging Inc. is a development-stage company focused on the development of novel diagnostic tests for the detection, staging and prognosis of disease. The following technologies have been licensed by the company: Rolling Circle Amplification, a procedure for detection, identification and quantitation of genes and the proteins they encode; MFISH (multiplexed fluorescent in situ analysis), a technique for facilitating chromosomal analysis; and AFD (allele frequency distortion), a method of identifying genes associated with disease and response of patients to therapy. Molecular Staging has facilities in Guilford, Connecticut and Allendale, New Jersey.