Successful Development Of Prototype Assays

International medical diagnostics company Panbio Limited has announced that it had developed two prototype immunoassays using their proprietary panDA Homogeneous Assay technology.

Panbio's prototype panDA Homogeneous Assays are able to specifically and accurately detect and differentiate IgG antibodies induced by infection with Herpes Simplex Virus (HSV) 1 and HSV 2 in validated serum samples.

Commenting on the achievement of this milestone, Panbio Acting CEO, Dr Stuart Hazell said, "This is clear evidence that the panDA Homogeneous Assay technology is capable of differentiating similar analytes with high specificity, which is an area where other homogeneous immunoassay platforms typically flounder. Successfully demonstrating that the key components of the system and the analyte interact specifically and generate a clear signal represents an important breakthrough."

The announcement marks the achievement of a key milestone in developing the panDA Homogeneous Immunoassay technology. "We have achieved the first functional prototype assays based on Panbio's proprietary panDA Homogeneous Assay technology within the timeframe previously indicated to the market," said Panbio Chairman, Maj Gen (Ret) Peter Arnison.

Key advances achieved in the development of the prototype panDA Homogenous Assays include:

• Sensitive and specific detection of a type specific antibody, IgG, induced by specific infection with either HSV 1 or HSV 2, with little or no cross reactivity between analytes.

• Performance data obtained using a true homogeneous immunoassay format. A serum sample is added to a master reagent mix, which if positive produces a colorimetric signal that may be detected shortly thereafter.

• Results that are comparable with those obtained by testing with the market leading kits using the current ELISA technology.

• Generation of performance data by in-house testing of a panel of 150 samples.

• The assay system uses B-Lactamase enzyme fragments that have been successfully engineered to be resistant to B-Lactamase inhibitors as announced in October 2006.

The technology represents a potentially great advance in medical and veterinary diagnostics. Reduced diagnostic test processing times down to as little as 10 minutes are possible, down from up to three hours using current technology. Quicker diagnosis will benefit patients, physicians and clinical laboratory customers.

Furthermore, the technology allows immunoassays to be performed in fewer steps, heavily reducing the complexity of performing the assays by instrument or by manual operation, hence reducing costs and the potential for operator error.

Given the extraordinary simplicity of the assay procedure, the potential applications for the technology in the clinical laboratory are diverse.

"One of the advantages of panDA Homogeneous Assay technology is that they don't necessarily need to be performed on a highly complex and expensive instrument," said Panbio Acting CEO, Dr Stuart Hazell.

"Assays using this technology could be run on many existing laboratory instruments, including open instrument platforms such as automated ELISA instruments and closed instrument platforms such as clinical chemistry analysers.

"The assays could also be run in hand held point-of-care (POC) testing devices allowing diagnosis of a broad range of conditions at the bedside.

"By exploiting panDA Homogeneous Assay technology you could envisage clinical laboratories where a single instrument is capable of performing immunoassays, clinical chemistry assays and assays for critical biomarkers."

The achievement of this milestone does not mean that the project is accomplished. The team will now be focusing on developing other prototype assays to further prove the performance of the technology, expanding the assay technology's performance and producing the first batch of assays to be used for independent clinical trials. These and other matters will be critical developments undertaken in 2007.

A number of further technical developments are required to deliver a robust commercial assay system. Thus, there remains both technical and commercial risk associated with this technology.

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Panbio is an 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 to a worldwide customer base. Panbio products are used in the diagnosis of over 30 disease states. The company is recognised as a world leader in tests used in the diagnosis of flaviviruses and other arthropod-borne viruses.

Contact: Dr Stuart Hazell
Research Australia