Diagnostic Development

Burnet has a strong culture of translating research outcomes and has been successful in developing and partnering novel technologies such as vaccines, diagnostics and therapeutics some of which have reached the market

A core capability of Burnet is the development of novel Rapid Point-of-Care (RPOC) diagnostic tests through the expertise of Associate Professor David Anderson and his team.

Associate Professor Anderson’s laboratory has developed a number of RPOC tests for use in the developing world including hepatitis E, hepatitis A and Active Syphilis tests and has been able to successfully partner with manufacturers to bring the hepatitis E test to the market.

Rapid Point of Care Diagnostics

Diagnostics play a critical role in increasing access to quality treatment for those in the developing world, particularly for infectious diseases such as hepatitis and HIV.

Unfortunately, the majority of those individuals living in rural and remote areas of the developing world have limited access to testing mainly due to the issues of logistics, training and equipment associated with many of the tests that operate routinely in centralised laboratories around the world.

There is a clear need for the development of simple, cheap and sophisticated tests that can be operated without associated infrastructure and able to be used in the field.

Burnet aims to meet this need through the development of RPOC tests and has particular expertise in the development of lateral flow tests that operates in a similar format to a pregnancy test.

The ability to develop diagnostics able to be operated in remote and rural areas in the developing world is in line with Burnet’s mission to achieve better health for poor and vulnerable communities throughout the world.

Lateral flow test typically work by detecting the presence or absence of a target analyte in a sample. They are a form of immunoassay where the test sample flows along a solid substrate which has been impregnated by relevant reagents such antibodies or antigens.

After the sample is applied the sample encounters these reagents which cause it to change colour and become bound to the reagents on the test line. Results are typically read as either positive or negative and in some cases will be read in reference to a test line.

Team Experience

Associate Professor David Anderson is the head of the Diagnostic Development Laboratory at the Burnet Institute and has extensive commercial and product development experience. In addition to his role as Deputy Director of Burnet, he heads the Office for Business Development, Innovation and Research which is focused in identifying unique funding sources including commercial sources as well as identifying cross-institute collaborations. He is a co-inventor on 10 patent families, including the CD4 ELISA patent and is author on more than 20 peer reviewed papers in the areas of diagnostics and vaccine development. Experienced in deal negotiation, he has successfully licensed three Burnet developed diagnostic technologies to international diagnostic manufacturers.

Mary Garcia leads the R&D team in the Diagnostic Development Laboratory. With more than 20 years experience in commercial development of ELISA, and rapid point-of-care diagnostic tests in both Industry and research settings, Mary was involved in the development of the first malaria rapid test that is now sold worldwide.

Associate Professor David Anderson at the NHMRC Ten of the Best Publication launch. Photo courtesy of NHMRC/Marcus Fillinger - Emulsion.

Diagnostic Tests Developed at the Burnet

  • Hepatitis E

The Burnet team developed the first HEV IgM Rapid Assay to detect IgM antibodies to Hepatitis E virus (HEV) in human sera. It was designed as a diagnostic tool for the detection of anti-HEV IgM in patients presenting with symptoms of acute viral Hepatitis.

Burnet Institute first developed the assay in 1998 in association with AMRAD ICT. The assay was highly sensitive, performing as well or better than the competitor IgM ELISAs in a number of published studies. The test is now sold under license worldwide by MP Biomedical (Asia-Pacific).

  • Active Syphilis

Syphilis remains a worldwide public health problem. The World Health Organization (WHO) estimates that there are 12 million new cases of syphilis each year, with more than 90 percent occurring in developing nations. In many developing countries, congenital syphilis remains a leading cause of still births and deaths among neonates. In countries where syphilis is less common, rates of infection are increasing particularly in men who have sex with men.

A wide range of diagnostic tests exist to diagnose both active and past syphilis infection, however many of these tests are of limited value in primary healthcare settings especially in developing countries.

Rapid point-of-care (RPOC) tests for the detection of antibodies against Treponema pallidum have been widely available for a number of years, however there are no RPOC tests that can specifically detect IgM class antibodies to T. pallidum and none that can distinguish between infections that are active or those that have been treated in the past.

Hence current RPOC tests have limited value in areas where syphilis is endemic or in some high risk groups. Burnet Institute has developed a simple, rapid test that allows the detection of T. pallidum specific IgM, without the interference of specific IgG.

The Burnet Syphilis IgM rapid assay represents the first rapid point of care assay for the detection of T. pallidum specific IgM, and should be a valuable tool for the improved control of syphilis worldwide.

  • CD4 T cell Test

After six years of development in the laboratory, Burnet Institute’s innovative point-of-care (POC) CD4 test has been officially launched at the AIDS 2012 Conference in Washington.

VISITECT® CD4, developed by Burnet Deputy Director Associate Professor David Anderson, Burnet Associate Director Professor Suzanne Crowe AM, and their team, is an affordable point-of-care (POC) test aimed at reaching HIV-positive patients around the world.

Before HIV infected patients are treated with anti-retroviral drugs their CD4 T cells must be below 350 cells per microlitre (according to current WHO treatment guidelines).

The conventional way to measure CD4 T cell levels is through sending blood samples to be tested via flow cytometry (FACS) which is an instrument that requires large capital investments to purchase and then train scientific staff to maintain and operate. Most laboratories and clinics in countries most affected by HIV and AIDS are unable to monitor CD T cells, particularly in remote and rural settings.

Associate Professor Anderson and his team have developed a novel rapid point of care for the measurement of CD T cell levels in a similar format to a pregnancy test and only requires a finger pick of blood. The test does not require highly trained personnel to operate and can be performed in remote settings by health out-reach workers giving a simple treat or no treat result.

The test works by measuring the amount of cell associated CD4 using a sandwich capture assay where the sample line is checked against the test line to give a treat or no- treat result. The test is undertaking field trials in India and Africa. Burnet is negotiating the licensing of developing world rights to the test.

Collaborative projects

The Burnet diagnostic development team has worked with a number of different organisations to assist them in the development of unique and novel rapid point of care diagnostics. These relationships range from straight contract work to collaborative projects in areas where the Burnet has a focus interest.

Axxin Ltd

Associate Professor Anderson and his team are collaborating with Axxin Ltd in Melbourne, Australia on the development of an inexpensive and robust instrument/reader for the CD4 test. This instrument provides greater accuracy and assists in training and quality control. The additional capabilities of the Axxin instrument will be important in the development of other much-needed point of care tests.

Contact Details

Serina Cucuzza

Executive General Manager, Commercial Strategy, Intellectual Property and External Affairs

Telephone

+61392822204

Email

serina.cucuzza@burnet.edu.au