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article imageQ&A: Hand-held alternative to the blood test in development Special

By Tim Sandle     Jun 6, 2019 in Science
Emerging and sophisticated technology now enables people to use their smartphone and a single tiny drop of body fluids (i.e. blood, saliva, urine, and/or sweat) to deliver clinical lab-quality. Steven Chou from Essenlix explains more.
Princeton University professor Steven Chou is the founder of digital health company Essenlix. Professor Chou is the developer of a proprietary, low-cost mobile health self-testing platform called the iMOST works. Chou believes the device will transform diagnostic testing in medical treatment—and ultimately people’s lives and the medical labs themselves.
Professor Chou has developed the device by implementing nanotechnology, advance imaging, and artificial intelligence/machine learning into diagnostic testing. The technology platform is designed to deliver clinical lab-quality test results using a simple device, as he explains to Digital Journal.
Digital Journal: Please can you describe the novelty of this kind of technology? What exactly is a mobile health self-testing platform?
Professor Chou: Digital personal health has often been anticipated to be the next major advancement in healthcare. However, that has yet to become a reality in large part because of the lack of a reliable instant self-testing platform for diagnostics that is accurate, digital, rapid, affordable, mobile, and that can also be used by anyone, anywhere, anytime.
The iMOST platform, an industry first, allows a person to evaluate diseases and health related analytics in their own body, including cells, proteins, small molecules and nucleic acids, via a single tiny drop of body fluids such as blood, saliva, urine, sweat, and others using a smartphone, all within 60 seconds.
DJ: How does the technology differ from other, more conventional lab testing technologies?
Chou: Diagnostic testing is a vital and necessary procedure for diagnosing diseases and monitoring health conditions. However, today’s clinical lab testing requires a “perfect” or “precision” paradigm, meaning it must be free of errors and imperfections to produce accurate results. This “precision” can only be achieved via big, complex machines in extensive laboratory settings, which is why it’s so inconvenient, time-consuming, and expensive.
What makes iMOST unique is that it completely bypasses the traditional approach to diagnostic testing through the development of a fundamentally new paradigm: the “adaptive paradigm,” which can produce clinical lab-quality test results even when the sample, device, process, and operation are imperfect.
DJ: How does the device work?
Chou:In terms of how it works, the iMOST reader attaches effortlessly to a smartphone and utilizes a proprietary, user friendly app to analyze the samples, display test results, and transmit data to a patient’s healthcare provider. A tiny drop (microliter) sample of blood (finger-prick), saliva (cheek swab), or urine is deposited on a stamp size test card, which is inserted into the reader. The user launches the app and activates the reader with two clicks. Results are displayed on the smartphone screen within 60 seconds.
DJ: What are the main advantages with the technology?
Chou:Key advantages that iMOST has over traditional diagnostic technologies include the fact it is mobile, allowing personal use anywhere anytime, and with no need for medical professionals. The results are fast (obtained in under 60 seconds); plus the device is accurate and easy-to-use. Further, the device is a small, lightweight and portable reader, powered by a smartphone’s battery with no external power source required.
DJ: What kind of results have you seen so far with this technology? How encouraged are you by the performance of the technology so far?
Chou:iMOST has undergone thousands of lab tests and extensive clinical trials that compare the new technology to traditional devices.
In two trials of 92 patients total run at Hunterdon Hematology Oncology in New Jersey, we tested patients with both the standard machine and its blood test. What resulted was a 6 percent difference on average between Essenlix's white and red blood cell counts and what traditional machines found, and a 3 percent difference in hemoglobin measurements, all within the FDA requirements for allowable total error. Bottom line: iMOST’s error was clearly smaller than the FDA's requirement and we are pleased and encouraged that the data was very good.
With this data, Essenlix is working with the FDA to move toward approval and expect to publish the clinical trial results in an academic journal in the near future.
DJ: What kind of an impact do you think this technology can have within the realm of diagnostic testing?
Chou:iMOST can replace conventional, inconvenient, time consuming, and expensive lab-testing. It will significantly advance personal digital health and play a key role in making healthcare available to much of the world’s seven billion population.
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