When it comes to stopping the global HIV epidemic, diagnosis and treatment are the key requirements. But unfortunately, conventional HIV tests require cold-chain transport of blood samples to professional laboratories that are widely unavailable in impoverished regions where the spread of the disease is most acute. A rapid, point-of-care diagnostic test invented by blood scientist and researcher Helen Lee (75) is tilting the scales: It delivers instant results based on a simple blood sample via robust test kits specifically designed for the often challenging conditions in resource-poor regions of the world, including high temperatures, humidity and intermittent electricity supply. Moreover, Lee’s laboratory is currently expanding the test platform to detect influenza A and B, as well as a combination test for chlamydia and gonorrhoea.
For this achievement, the European Patent Office (EPO) has named Lee as one of three finalists for the European Inventor Award 2016 in the category “Small and medium-sized enterprises (SMEs)”. The winners of the 11th edition of the EPO’s annual innovation prize will be announced at a ceremony in Lisbon on 9 June.
“The fast and accurate testing method invented by Helen Lee brings reliable diagnostics of HIV infections to areas of the world where they are needed most,” said EPO President Benoît Battistelli announcing the European Inventor Award 2016 finalists. “The tests prove ideal to provide point-of-care diagnostics under challenging conditions and for the first time also allow monitoring of the efficiency of medical treatments without laboratory infrastructure.”
Lee and her team at the diagnostics development unit of the University of Cambridge created the fundamental principle behind simple, rapid, point-of-care diagnostic tests for a range of different infectious diseases. To bring the technology to market in an affordable and scalable manner, Lee set up the company, Diagnostics for the Real World, a spin-out of the academic unit at the University of Cambridge. Thanks to Lee’s innovation, supplemented by her company’s co-operation with international outreach organisations, HIV testing can now be administered via “test-and-treat” centres in areas where the epidemic is most rampant. While the spread of HIV has slowed in the Western world, around 25m people in sub-Saharan Africa – or 70% of the global total – are currently living with HIV. Over 40 000 people have already been tested for HIV using Helen Lee’s test in Malawi and Uganda in cooperation with Doctors Without Borders, along with several other relief organisations.
Introduced in 2011 as the SAMBA (Simple AMplification Based Assay) system, Lee’s simple test consists of mixing a patient’s blood with so-called nucleic acid-based assays, a combination of chemicals in a disposable cartridge that will change colour in the presence of viral RNA in blood plasma samples. Blood samples are fed into a machine that inserts a dipstick – similar to a pregnancy test – that changes colours in specific patterns: Two red lines on the stick indicate a positive sample, one line a negative, and no line is an invalid test. This brilliantly simple approach unlocks two major advantages. First of all, results are visible to the naked eye, requiring neither microscopes nor trained personnel to process. Secondly, the test responds to actual viral RNA – not antibodies to the virus like other tests – and can therefore diagnose infections among infants born to HIV-positive mothers. Infants under the age of 18 months are too young to have developed antibodies of their own and will likely die before their second birthday without treatment.
Unlike other tests, the cartridges do not require cold storage or transport – making them perfectly suited for conditions in Africa – and the kits can be stored at temperatures of up to 37°C for nine months. The machines run on electricity but can switch to eight-hour batteries during outages.
The innovation allows outreach organisations to bring an unprecedented level of diagnosis and care to HIV hot zones. Besides reliable detection of the HIV infections, the tests also monitor viral load – the amount of live virus material – in a patient’s bloodstream, a critical parameter for gauging drug dosages for treatment, previously only available in advanced laboratory settings. By delivering rapid results, the tests also solve the problem of patients being “lost to follow up” – by showing up for tests, leaving, and not returning for diagnosis – which can amount to 30-70% of patients in some areas. The invention can also significantly lower the cost of HIV testing in the Western world, and the SAMBA HIV Assay for therapy monitoring has recently received CE regulatory approval for use in Europe.
Lee started her career in diagnostics at the Centre National de Transfusion Sanguine (French National Blood Transfusion Centre) in Paris, where her group developed one of the first monoclonal antibody-based assays for detecting hepatitis B surface antigen – licensed as the MONALISA HBsAg assay – still used today. In 1991, Lee joined Abbott Laboratories and soon assumed responsibility for the Probe Diagnostics Business Unit managing over 100 people and an annual budget of over €17m.
But in 1996, Lee chose a different route: The philanthropist and avid football fan withdrew from commercial pharmaceutical development to focus on researching test assays for resource-poor regions at the University of Cambridge where she founded the Diagnostics Development Unit. It was here her breakthrough HIV test was perfected. Over the years, the unit has filed 12 families of patent applications, with around 20 granted national patents.
The company Lee founded in 2002, Diagnostics for the Real World, operates under a 15% cap on profits to develop point-of-care diagnostic assays for developing countries. Headquartered in Sunnyvale, California, and in Cambridge, UK, the company has successfully raised around €60m in research and health grants to date. The winner of numerous awards, including the 2006 British Female Inventor in Industry Award, Lee, a dual French/UK citizen, is outspoken about real-life applications of her work: “If all we did was to develop a prototype or publish papers, then we would have failed.”University of Cambridge material