rHealth Diagnostics: Blood Test via Bluetooth

20. March 2015
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Small, cheap, fast and reliable – a new generation of mobile, handy device has set out to replace the classic diagnostic laboratory. But what can this much vaunted device, otherwise referred to as the tricorder, really do, and when will it be ready for implementation?

Creating a complete blood count picture with one drop of blood? Thanks to microfluidics and nanotechnology, this is already technically possible today, but in everyday clinical practice and in the hospital there’s still no path that gets around that method dreaded by many patients: venipuncture. Samples need to be taken to a laboratory, examinations require complex equipment and expensive technical personnel, and the results first reach the doctor some days later. However a new device is now revolutionising the world of diagnostics.

RHEALTH: The panacea of telemedicine?

The heart of the “Reusable Hand-held Electrolyte And Lab Technology for Humans”(rHEALTH) is a microfluidic chip over which the sample gets diluted, mixed and pumped through the device. The configuration of the device, which uses non-invasive fluorescence optical methods, is supplemented by multiplexing nanostrips. These nanostrips work like normal urine test strips, but are shrunken down to micrometre size. The device can currently perform reliably cell counts. Moreover, it is capable of checking for HIV, determining Vitamin D levels in the blood and detecting various protein markers such as TNF and IFNg. Through the use of an additional connectible patch rHEALTH can convey vital signs such as heart rate and body temperature. “Our rHEALTH technology is highly sensitive and quantitative in action”, emphasises Dr. Eugene Chan, who as CEO and Scientific Director of the DNA Medicine Institute (DMI) is responsible for the development, production and distribution of rHEALTH.

The size of the unit, at 20 cm x 10 cm x 1.5 cm, is very practical for handling. It manages to get its work done using a single drop of blood (or other body fluid). It is being developed by the DMI researchers in collaboration with the American space agency NASA and should therefore be fully operational under conditions of weightlessness – an important step in providing medical care for astronauts in manned space flight. Yet rHEALTH should also find applications for use on Earth.

Clear advantages, but no approval yet

A portable diagnostic device, the use of which allows patients at home to check important parameters, could prevent unnecessary consultations and relieve the doctor’s workload. Furthermore, such a device enables much tighter monitoring than is currently possible. With chronic and degenerative diseases in particular this could be a decisive advantage. What’s more, first responders, paramedics and emergency medical technicians would benefit from such a quick and handy device. Miniaturisation also decreases diagnostic costs.

Another advantage: rHEALTH can improve patient compliance. In order to get the small amount of blood required, a lancet prick is enough, something which – especially when working with children and individuals with difficult to access veins, or individuals who need to be examined frequently, such as cancer patients – represents a significant lightening of burdens. Nevertheless, rHEALTH has yet to prove that it can compete with the sensitivity and specificity of conventional analytical methods. The manufacturer DMI has not as yet successfully responded to this with the relevant studies.

In order to conquer the telemedicine market, DMI is planning three types of devices: rHEALTH One for research, rHEALTH X for doctors and rHEALTH X1 for customers. Before being able to be sold, rHEALTH X and X1 need to acquire an approval from the US Food and Drug Administration (FDA), whereas rHEALTH one only needs to get permission via an institutional review board – the American equivalent of the German Ethics Committee – and is therefore already available to be used by research institutions. “DMI can deliver devices within a few weeks to interested researchers”, promises Dr. Chan. Chan’s team wants to use researchers’ experience in order to improve the device. Before rHEALTH finds its way to physicians and patients years could yet pass by. “The next challenges”, says Dr. Chan, “are expansion of the device’s use to include more tests, an increase in scale of production, and the expensive process of commercialisation”.

Excellent idea

In November, the DMI team and its rHEALTH concept won the Nokia SensingXChallenge 2014 and was able to take home 525,000 US dollars. And the next price is already envisaged: as one of ten teams it is participating in the DMI Qualcomm TricorderXPrize, which is endowed with ten million US dollars. To win the prize rHEALTH needs to successfully diagnose at least 16 entities, including anaemia, atrial fibrillation, chronic obstructive pulmonary disease (COPD), diabetes mellitus. hepatitis A, leukocytosis, pneumonia, otitis media, sleep apnea, stroke, tuberculosis and urinary tract infection. Furthermore, the device has to reliably determine the vital signs blood pressure, heart rate, oxygen saturation, respiratory rate and body temperature. In collaboration with the University of California San Diego (UCSD), 500 volunteers will evaluate the TricorderXPrize devices in summer 2015. The FDA supports the process and advises the participating teams on all pivotal issues.

The competition is not sleeping

DMI is not the only company that wants to cut out and take a piece of the telemedicine cake for itself. Scanadu, a company founded in California in 2011, is also participating in the Tricorder Xprize, offering two products: Scanadu Scout, for the measurement of vital signs, and Scanaflo, for urine examination. When the two devices will be commercially available is however still unclear. In contrast another approach is being followed by Theranos. The Californian company has already since 2013 been offering its own service: patients in possession of a doctor’s statement can at branches of pharmacy retail chain Walgreens have a small amount of blood or urine or other body fluids taken from the body. The sample is sent in a timely manner to a Theranos laboratory and examined there through the use of patented miniaturisation and automation technology.

The winner of the TricorderXPrize will be announced in January 2016. The wait to have devices such as rHEALTH in clinics and medical practices will presumably have to go on somewhat longer, but that the future belongs to the handy all-rounders seems something indisputable.

 

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