Cheap and reliable diagnosis of diseases in rural areas, with lack of electricity or water, and inadequately trained healthcare staff are widespread problems in less developed countries. GSK is helping to develop simple, cheap, paper-based devices capable of diagnosing infections and saving millions of lives.
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Cheap and reliable diagnosis of diseases in remote, rural areas, with challenging weather conditions, lack of electricity or clean water, and inadequately trained healthcare staff are widespread problems in the less developed countries. In particular, poor maternal and child healthcare leads to significant mortality and morbidity with undiagnosed conditions being left untreated. With infectious diseases such as malaria and tuberculosis, point-of care diagnosis is not possible with the limitations in healthcare resources. Tens of millions of people's lives could be saved annually with a platform solution involving an open-innovation collaboration of expert partners.
In a specific example, a recent epidemiological study estimates that of the 30 million live births in Africa1, more than 300,000 babies were born with sickle cell anemia in 20102. In Sub-Saharan Africa it is estimated that 50-80% of children born with sickle cell disease die by age 5 due to infectious disease, many without being diagnosed as having the disease.
GSK is helping to develop simple, cheap, paper-based devices capable of producing quantitative diagnostic test strips at-site. These tests can be administered by minimally trained healthcare workers in hot, humid environments common in developing countries. The ante-natal pen uses a novel design with a dropper to deliver reagents consistently with a business model generating an income for the healthcare worker. The G6PD test uses an innovative visual screen which allows quantitative assessment in difficult to detect cases. Both designs are part of a wider platform which will revolutionise healthcare diagnosis and companion treatment in developing countries.
Systematic screening of newborns for SCD using a simple blood test is not a common practice in much of the developing world, particularly in rural areas. A simple, paper based microfluidic ELISA assay could identify infants with sickle cell disease, and distinguish them from those with sickle cell trait whom do not require intensive antibiotic therapy. Given its use in Sub-Saharan Africa, requirements might include: heat stability, independence of a quality water supply, the ability to use a portion of a blood sample while saving the remainder for confirmatory analysis, use of a blood spot on a filter card, as well as blood directly from an individual, use with adult and infant blood, will need to be examined and accounted for.
In a developing world setting many patients cannot afford the time or money to travel to central healthcare centres for medical treatment. Unpaid, volunteer healthworkers from the community travel out to remote villages and will take with them the low-cost diagnostic tests. The tests will screen pregnant women for ante-natal complications (including pre-gestational diabetes, pre-eclampsia and anemia). The tests cost less than 0.5 cents to administer due to the simple design - the reagents are administered using a dropper on to cheap filter paper. The test kit (~ 100 tests) is purchased by the healthworkers and the cost reimbursed with a profit when administering tests to patients. The filter strips are then tested with the patients urine or blood to give a very quick and easy reading which can be detected by untrained healthworkers. The patient is charged a small fee for the test and the healthworker makes a sufficient income to purchase another kit and provide for their families. If positive the patient is then referred to the local hospital for further testing by qualified health professionals to give effective treatments. For the G6PD diagnostic, many patients are at risk of side-effects from anti-malarial medications due to genetic mutations common in populations in the developing world. This diagnostic provides a rapid and quantitative view of the genetic deficiency, avoiding the use of expensive lab-based equipment, often not present in these settings.
Both tests have been developed in partnership with Johns Hopkins University student teams with advice from Jhpiego.
If diagnosed with sickle cell disease, prevention of infections with antibiotics and other early interventions such as folic acid supplements and adequate hydration can be initiated within the first year of life. Implementation of newborn screening programs and subsequent treatment has been demonstrated to result in a corresponding reduction in mortality in these children.
The WHO supports a number of consortia who are investigating point of care diagnostics. The global expertise that GSK brings in discovery, development and distribution of novel medicines and vaccines, particularly in the developing world bring unique strengths in the industry. GSK's expertise in diseases of the developing world, including the development of malaria vaccine Mosquirix, and extensive partnerships with NGOs, governments and institutions across the world make us the ideal partner. Johns Hopkins and Jhpiego develop in innovative solutions for global healthcare issues particularly around novel devices have been recognised by the award of several grants and awards (Gates, USAID).
Other competitors in the field include PATH and FiND who have experience in developing diagnostics.
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