Thinking Beyond the Box

in the late 80s and 90s, cell phones began displacing land-lines by eliminating the eternally-tangled, helical cords that tethered a caller to a home, office or pay phone. Cell phones afforded the flexibility to communicate whenever and wherever one chose, resulting in a complete restructuring of daily planning and information management. In less than a generation, not only was the telecommunication industry transformed to its core, but society as well.

Clinical diagnostic testing is following a similar trajectory, albeit several generations behind. For most blood tests, there exist benchtop analyzers that test human samples and produce clinical data in minutes. These devices are becoming increasingly popular in hospitals and clinics, but remain too expensive and complicated for ubiquitous use, and like traditional tethered land-lines, restrict when and where blood tests can be performed.

We are pioneering an analyzer-free blood test that effectively cuts the cord and allows doctors and patients to test anywhere and at any time, without training or access to sophisticated equipment. The flash-drive sized devices take a single drop of blood and in minutes display measurements for one or more biomarkers on your PC or phone. We think this radical new approach has the potential to modernize blood testing and transform healthcare in much the same way the cell phone changed telecommunication.

Glucometers are salient harbingers of this transformation. They were introduced in the 1980s and gave diabetic patients the ability to monitor their glucose levels several times a day. Glucose testing quickly grew to a $10+ billion market, approximately 15% of the entire blood testing market and close to 2/3 of near patient testing. Glucose is present in high abundance in the blood stream, and unfortunately the low cost, easy-to-use glucose electrochemistry technology can't be applied universally, as most other analytes require different detection modalities or are in blood at lower concentrations.

Developing a novel blood blood test is technically very challenging and fraught with pitfalls. The development of cell phones leveraged advances in electronics miniaturization, best characterized by Moore’s Law: the doubling of the number of transistors on a chip every 18 months. Transistor scaling permitted effortless combination of more sophisticated analog and digital signal processing functions on a monolithic microchip. Transistors are now similar in size to bio-molecules so we have unapologetically co-opted Moore’s Law to implement a dense array of sensors for detecting multiple analytes from a single drop of blood. The $1+ trillion of capital investment in semiconductor manufacturing has enabled these microchips to be produced, packaged, assembled and tested for mere pennies at volume. However, achieving high volume and product reliability is no straight-forward task and requires very foresighted product and technology planning - like for example launching in the veterinary markets.

Digital microchips are essential to capturing the enormous quantity of information circulating in our bloodstream. The human body consists of approximately 100 trillion cells that coordinate their function by transmitting and receiving bio-molecules. Biologists see bio-molecules, data engineers see discrete packets of digital information. Our circulatory system is effectively a vast digital "cellular" telecommunication system, strikingly similar to the internet. Yet the vital information coursing through our fingertips is rarely accessible, and so we have set as our mission to digitize all the information in a single drop of blood.

Unfettered access to our biological information will come with its own set of challenges and opportunities. Patients and doctors can avoid being overwhelmed by large amounts of often contradictory data using novel AI tools. Fundamentally, the digital microchip is a deeply personal technology, at the heart of the personal computer, smartphone and every single life-changing app. Microchips are now woven into every facet of our society. Intuitive, AI-enhanced, data-rich user experiences are a second nature for a technology that can perform complex functions in nanoseconds and readily access the cloud for additional computational horsepower and context. Imagine a disposable blood test that runs an instructional video on your phone, that automatically disables itself if improperly stored or used, that displays intelligible, beautifully visualized and encrypted medical information, and that, with your approval, transmits that information to your doctor or AI assistant for review. That world is fast approaching.

Advances in medicine along with the need for at-home testing are driving convergence of the microchip and life science sectors, and we are at the forefront. Our approach represents the easiest and, frankly, the only roadmap for making all the data coursing through our fingertips available at our fingertips. We think that similarly to Moore's Law, we will see in our lifetime a persistent exponential increase in the amount of data we can collect from a single drop of blood at home. Narrow, infrequent and expensive snapshots of our health as are common today will no longer suffice in the nuanced, highly personalized context of tomorrow. Comprehensive information from a drop of blood needs to be quickly and easily transcribed from bio-molecules to bits, encrypted and transmitted wirelessly to the cloud for analysis and record keeping. This is the future of diagnostics, and it is coming into focus; it will be ubiquitous, rapid and the information will disrupt our very understanding of life itself! The great digital information revolution is about to enter its next act: blood testing. Central to navigating both the challenges and opportunities, however, is the need to think beyond the box.