Panbio Executive Chairman Mr John Lee announced that Panbio's Advanced Technologies research team had completed the selection, development and validation of the enzyme fragments that form the backbone of the Forced Enzyme Complementation (FEC) system necessary to the development of diagnostic assays based on the concept of a Homogeneous Assay.
Homogeneous assays differ from conventional assay systems in that all of the elements necessary to detect an analyte, for example either a specific antibody or antigen, of the homogeneous system are contained within a single reagent pool. This has major time and cost advantages for the clinical laboratory using the system.
Panbio Advanced Technologies Division Research Manager Dr Edward Kachab said; "This is a significant achievement for the research team. We believe we are the first to demonstrate that a system such as FEC technology can perform effectively for in vitro diagnostic application.
"Previously published work has highlighted that similar approaches have suffered from high backgrounds and poor signal to noise ratios. We consider what we have achieved to be a first and is the essential step allowing us to move forward in developing prototype assays for infectious and other disease markers."
Panbio Chief Operating Officer and Head of the Advanced Technologies Division Dr Stuart Hazell, commenting on the achievement, said the milestone brings the technology one-step closer to commercialisation.
"With these results being achieved, we can now talk with a level confidence about realising a commercially viable homogeneous assay system," Hazell said. "We are now starting to actively promote the technology and begin discussions with potential partners who have an interest in exploiting this technology with Panbio."
The development has been supported by capital raised from Panbio investors and earlier this year these funds were augmented by a AusIndustry Commercial Ready grant of $3.45 million to enhance the level of support for the development and commercialisation of the Homogeneous Assay technology.
This first milestone reduces but does not eliminate the technical risk associated with the research program being undertaken by Panbio. The company continues to work to meet the objectives of the operational plan and execution process that has delivered this milestone result within the expected time frame.
The principle of Panbio's Homogeneous Assay platform is based on Forced Enzyme Complementation, whereby an active enzyme is separated into two components. These two components, or enzyme fragments, are designed not to reassociate under normal conditions. To each enzyme fragment may be linked a system that can capture a specific target analyte, for example an IgM molecule generated in response to a specific agent of disease. When a patient's sample containing the target analyte is added to the reagent mix, the analyte interacts with the "capture" system, the two enzyme fragments are forced together and the complementary enzyme components generate an active enzyme, which then converts the enzyme substrate to a coloured product.
In the system used to validate the enzyme fragments reported today, Panbio used a biologically relevant model analyte detection system. The work completed to date, including the model system, is currently the subject of a provisional patent application recently filed.
In practical terms from the end user perspective, a Homogeneous Assay will involve adding a sample, example sera to the test reagent followed by a short incubation step, with the colour development being measured by an instrument. The multi-steps of reagent addition, incubation and washing required with today's Enzyme-linked Immunosorbent Assay (ELISA) are eliminated, reducing assay-processing time from hours to minutes.
Panbio Limited (ASX:PBO) is a listed international diagnostics company headquartered in Brisbane, Australia. With operations in Brisbane and Columbia, Maryland U.S.A., the company develops, manufactures and markets diagnostic tests primarily for the detection of antibodies against agents of infectious disease. Panbio products are used in the diagnosis of over 28 disease states. The company is recognized as a world leader in tests used in the diagnosis of flaviviruses and other arthropod-borne viruses including the first clinical diagnostics for Ross River Fever, Dengue Fever and West Nile Virus.