RESEARCH TRANSLATIONNEW HORIZONS:CD4 TEST ON THE FRONTLINEProfessor Stanley Luchters(centre) in Africa.“It’s easy to diagnose HIVbut it’s hard to identifythose who need therapy.Our test will change that,providing cost-effectivetesting for up to 33 millionpatients worldwide.”— Associate Professor David Anderson,<strong>Burnet</strong> <strong>Institute</strong>6 IMPACT Summer 2012After six years of developmentin the laboratory, <strong>Burnet</strong>scientists have developed theVISITECT® CD4, an affordablepoint-of-care (POC) test aimedat reaching HIV patients aroundthe world.<strong>Burnet</strong> <strong>Institute</strong> DeputyDirector, Head of the Officefor Business Development,Innovation and Research, andpart of the brains trust behindVISITECT® CD4, AssociateProfessor David Anderson saidthe test development was a lotlike a relay race.“We had the technicalcapability of developing thetest in the lab, validating itwith help from The Alfredhospital, through to thebusiness development officeto identify the right partner tocommercialise, manufactureit and get it out into the field,”he said.The baton is now passedto Co-Head of the Centre forVirology and infectious diseasesphysician, Professor SuzanneCrowe AM and Professor StanleyLuchters, acting Co-head of<strong>Burnet</strong>’s Centre for InternationalHealth, to undertake fieldvalidation studies to determinethe feasibility of the test.“What I really hope is that infive years time we could go intoa remote setting anywhere inAfrica and see people actuallybeing tested with the VISITECT®CD4 test and getting appropriatecare as a result,” AssociateProfessor Anderson said.
FROM LABTO VILLAGEProfessor Luchters, ProfessorCrowe AM and other <strong>Burnet</strong>public health specialistsare now rolling out researchprojects using the VISITECT®CD4 test in sub-Saharan Africaand Papua New Guinea.The first of these projectsto begin in 2013 is supportedby a USD$250,000 grantfrom the Grand ChallengesSaving Lives at Birth Initiative,jointly funded by USAID, theGovernment of Norway, the Bill& Melinda Gates Foundation,Grand Challenges Canadaand the UK’s Department forInternational Development(DFID). The VISITECT®CD4 test was one of 15innovations to receive theaward from more than 500applications worldwide.Over 15 months, the projectwill involve 275 HIV-infectedpregnant women, with 150women taking part from SouthAfrica and 125 from Kenya.Various types of healthfacilities will enrol studyparticipants including a largereference hospital in SouthAfrica with a high patient load,and in Kenya, a low-level,health centre-type facility, arural public district hospitaland a private health clinic.The project will gatherinformation from health careworkers about how feasible it isto use the test in the field, howwell it works in practice, howeasy it is to read the results,and then compare the results tothe highly technical referenceflow cytometry test.“In southern Africa,about half of maternalmortality and a thirdof infant mortalitycan be attributed toHIV infection. Nearlyhalf a million babiesare born each yearwith HIV – almostall children under 15with HIV have got itfrom their mothers,”Professor Luchters said.“If this new test is carriedout at the first antenatal visitafter HIV-infection has beendetected in pregnant women, itcould allow for rapid initiationof antiretroviral interventionsand save the lives of thousandsof HIV-infected pregnantwomen and prevent infection intheir newborn infants.”Professor Luchters saidin Sub-Saharan Africa HIVinfectedwomen usually comelate to antenatal clinics andoften only come once. Theyneed treatment to preventmother-to-baby transmissionbut many rural settings don’thave a laboratory close by so itcan take weeks for the resultsto come back, and you need torely on the mother to return tothe clinic.“Of course, discoveringa vaccine or a curewould be better, but inthe meantime we needto make best use ofthe antiviral drugs thatare available, and thatmeans CD4 testing,”Associate ProfessorDavid Anderson.WHAT’S AHEAD?Associate Professor Anderson and his team are now planningfor a test that can be used in a similar way to the VISITECT® CD4diagnostic to determine when hepatitis B-infected patients need togo on antiviral therapy.“In China there are about 250 million people suffering fromchronic hepatitis B with very few of them being regularly tested forthe amount of virus (viral load) or liver disease (ALT) because it’sjust too difficult,” he said.“At the moment the test for viral load and ALT need a lab– developing a viral load test for hepatitis B is going to bechallenging for us but we have a novel idea and given the time andsignificant funding this project is achievable in two years.”Hepatitis B is a blood-borne virus that attacks the liver causingboth acute and chronic disease. Two billion people worldwide areinfected with the virus, 350 million live with chronic infection and600,000 people die each year due to HBV related illness.BURNET LICENCES CD4 TEST<strong>Burnet</strong> has licensed the VISITECT® CD4 test to global diagnosticsorganisation, Omega Diagnostics Group PLC for its manufactureand sale throughout the world, and this relationship wasofficially announced at AIDS 2012, the International AIDS SocietyConference in Washington.Although VISITECT® CD4 is designed to be instrument-free,<strong>Burnet</strong> has developed a complementary test reader in collaborationwith Axxin Pty Ltd in Melbourne. The AX-2 reader allows the testresults to be stored and transferred electronically, as well asproviding training and objective test analysis, which will be veryuseful in the training of health-care workers and in validation trials.VISITECT® CD4 aims to reach millions ofHIV patients around the world currently notreceiving treatment.The team behind the development (back), Mary Garcia,Associate Professor David Anderson, (front)Professor Suzanne Crowe AM and Nadine Barnes.IMPACT Summer 2012 7
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