An International Diagnostics Centre interview with Sam Sia
Sam Sia is Associate Professor of Biomedical Engineering at Columbia University. His research interests are on microfluidics, the miniaturisation of devices for health and medical problems and the current focus of his work is development of a small Point-of-care (POC) device that can be attached as a dongle to a smartphone and used to test for HIV and syphilis. A recent trial in Rwanda tested the device and the results have been very encouraging both in terms of the efficacy of the test and the patient’s response (Visit http://stm.sciencemag.org/content/7/273/273re1 for the full article).
How did you come up with the idea for a dual HIV/syphilis POC test?
I have been interested in miniaturising diagnostic devices to enable them to be used for POC testing in non-laboratory conditions for over 10 years. Following discussion with leading experts in the diagnostics and medical device fields, including with Dr. Rosanna Peeling, it was clear a POC device that could test for both HIV and syphilis would be of great therapeutic benefit in low-middle income countries due to the prevalence and severity of these diseases in the developing world and the scarcity of medical resources. The current iteration of the device uses a smartphone for a power supply, even though the original version of the device was designed before smartphones were invented. The global ubiquity of smartphones and people’s familiarity with them changed the way we designed the device.
What are the biggest changes you have seen in the field of diagnostics over the past 5 years?
In recent years, there has been a large rise in the number of electronics companies that are interested in consumer health. Their shift into healthcare applications has given a big boost to both the growth and level of innovation in the sector. These new technologies have allowed individuals to assess a wide variety of their own biomedical characteristics like never before. Thisnewly generated public interest in the sector is forcing a lot of people in the traditional diagnostics field to think outside the box as there has been some complacency in the diagnostics field.
Another change is the involvement of the general public in the health care sector – individuals are now able to measure their own heart rate and other vital signs and are now better informed about what these measurements mean and what they should be in a healthy individual. This is one of the areas in healthcare where consumers are having a real effect.
One disruptive innovation that would greatly change the diagnostic environment would be the developing self-administered blood tests, as such tests are the gold-standard for many different medical diseases. We are on the cusp of such devices becoming commonplace and the effect that the direct involvement individuals could have on global public health by self-administering such tests is profound.
What are your future plans for the dual HIV/syphilis test?
The test is still being developed and refined: at some point the test will be globally launched in both the developed and developing world. The technology will be the same but the applications and the context which it will be used for are likely be very different. The development of the device will not be a sequential process but a tandem one working across both the developing and developed worlds as they are very different environments.
In the developing world, the test will allow public health agencies to provide high-quality diagnostics in areas where such previsions were lacking. Whereas in developed countries the potential market for the devices is huge as people are experienced at using high-tech consumer electronic devices. Consumers would be given the ability to monitor their own health with a degree of precision that has not been available up until now. Self-administration devices would enable the consumer to catch diseases and monitor them to gain control over their own health.
What has the response to the test been like?
One of the most encouraging things about the test has been the response from patients - in our Rwandan trial 97% of patients showed a preference for the smartphone test. The response of healthcare professionals was also enthusiastic, but we need to ensure that the test fits neatly into the HCPs workflow. One key issue is the type of sample required for the test: The ideal test sample would be whole blood as this could be administered into the test directly without any processing. However, almost all diagnostic tests work with sera or plasma which requires centrifugation or other processing to derive it from whole blood, and the facilities for this may not be present at the POC. This is one of the challenges we are encountering currently, but by working with the healthcare professionals we are confident we can fit the device into their current workflow.
The response from traditional diagnostic test manufacturers has been mixed as POC has the potential to disrupt their business. On the other hand, pharmaceutical companies are enthusiastic as they want something that works with their therapeutic agents and getting the agents administered more swiftly will likely result in a better treatment outcome.
What are the benefits of using an external device such as a smartphone as an integral part of your diagnostic test?
Using communication devices like phones in healthcare settings lends itself to good connectivity and automatic reporting of results. Additionally most people are familiar with smartphones so they would not need to be trained on entirely new equipment.
The vision from the beginning has been to be able to swiftly communicate accurate laboratory quality test results to a centralised location. These results could then could then be synchronised with patient records and be used to arrange better allocation of resources and to strengthen healthcare systems. Analysing regional-level data could have an array of positive benefits including identifying any potential outbreaks in disease. There are legitimate concerns about data protection and privacy which would need to be resolved, but there is an ongoing change in how people are communicating personalised information by electronic means and in the security systems that can be implemented.
One challenge when developing these lines of communication would be to ensure the data are easily transferable to an electronic medical record or other centralised database.