Disrupting Blood Testing

William Shockley, on the left, is holding the patent for the solid-state transistor he invented in 1947. Next to him is lesser known Arnold Beckman, a towering figure who perfected the spectrophotometer in 1940, a device that to this day is the workhorse of modern blood testing. The two men are celebrating Beckman Corporation’s financing of Shockley Semiconductor Laboratory, which shortly thereafter hired Bob Noyce, Gordon Moore, Eugene Kleiner and the rest of the “traitorous eight”, spawned Fairchild Semiconductor, Intel, Moore’s Law and jump-started Silicon Valley. Little do they realize that this picture uniquely captures the coincidental genesis of both the semiconductor and blood testing industries.

First transistor-base mainframe (left) and first spectrophotometer-based analytical mainframe (right)

Both transistor and spectrophotometer were integrated almost simultaneously into larger systems combining multiple discrete functions, called mainframes. The first query-to-answer solid state transistor mainframe was a basic calculator with automated punchcard feed launched by IBM in 1956. The first sample-to-answer analytical mainframe with integrated spectrophotometer, the Technicon Autoanalyzer, was developed in 1957 by pioneers Leonard Skeggs and Jack Whitehead. These systems continue to dominate their respective industries in the form of cloud computing and central labs. Yet soon after the first mainframes were deployed, visionaries began excoriating the inefficiencies and lack of access that centralized processing represented and set to working on more distributed implementations.

The personal computing revolution was in full swing by the time the Macintosh was introduced in 1984. Right on cue, Abaxis launched the Piccolo, the first rapid blood analyzer with integrated spectrophotometer and centrifuge. These desktop implementations were powerful innovations with respect to prior generation of mainframes, but they suffered from a subtle yet profound weakness: no one actually wanted them. What customers ultimately wanted was the information that these boxes provided and only grudgingly placed these expensive, bulky, yellow, plastic bricks on their desks.

Iconic PC Apple Macintosh (left) and the Abaxis Piccolo (right), the first spectrophotometer with integrated sample preparation

Transistor technology was accelerating at an exponential rate behind the scenes. The doubling of the number of transistors on a microchip every 18 months, or Moore's Law, meant that they were becoming cheaper, faster and better. Computing and telecommunication were poised to transform our world, and venture capital investors like Eugene Kleiner (ex-traitorous 8, founder of Kleiner Perkins) and Don Valentine (ex-Fairchild, founder of Sequoia) identified and funded technologies ahead of Intel-synchronized transistor nodes. The rest of the world looked on in disbelief as Silicon Valley redefined what was possible.

Rapid blood testing was left in the dust. Customers did not want a bulky and expensive analyzer, but rather the information it provided. And that information was incomplete. Blood testing spans thousands of applications across various segments like general chemistry, immuno-assays, nucleic acids, hematology, metabolomics and micro-biology, and no single analyzer could address them all. The value proposition of buying an analyzer limited to performing a small number of tests and therefore providing a narrow snapshot of the clinical picture didn't outweigh the costs of ownership in all but the most resource or time constrained settings. Tepid analyzer adoption became a bottleneck on consumable cartridge sales. And once placed, these analyzers became a corporate and technological anchor for the manufacturer, mooring further innovation. And so 30 years after its introduction, the Abaxis Piccolo received a touch-screen face-lift and remains state-of-the art.

The relentless miniaturization of transistors eventually led to the introduction of the universal information device, the smartphone, best exemplified by the launch of the iPhone in 2007. The prospect of a universal blood analyzer was compelling, but blood testing had not benefited from a scaling phenomenon similar to Moore's Law. And so Theranos' much anticipated attempt to produce a universal blood testing analyzer predictably descended into acrimony.

Fraud mas merely a symptom and not the cause of Theranos' failure. Theranos suffered from a fundamentally flawed business model that no amount of money or will power could overcome. The large number of indications a customer could want makes development, regulatory approval and deployment of a universal analyzer prohibitively expensive. Some indications cannot be performed from a finger-stick because the concentrations are too low or because interstitial fluids and lysis interfere with the results. The approach of a more limited general purpose analyzer is an intriguing one, but the low hanging fruit has been picked for immuno-assays, general chemistry, hematology, nucleic acid testing, etc. Novel analyzers must combine multiple analytical methods and offer a broad enough menu of tests to displace highly entrenched competitors, be they central lab services or existing single method analyzers. Displacing a competitor is a daunting proposition in the most dynamic sectors, let alone in healthcare. The slightest gap in the menu, the need for phlebotomy or any chink in the clinical data set makes selling or placing the instruments near-impossible and definitely expensive. Rather than displace competitors, why not complement them? Or better yet, why not disrupt them?

InD is introducing a new category of products designed to provide unique value propositions, extend the test menus of existing analyzers, and scale effortlessly to comprehensive panels over time. By leveraging microchip capabilities, the fluidics are simplified to passive capillaries that can be miniaturized capital efficiently. The analyzer, the barrier to adoption and product iteration, is eliminated. In an surreal twist of fate, our solution is the culmination of both Shockley and Beckman’s combined work: a high precision spectrophotometer integrated on a digital microchip. Combined with a passive drop of blood sample preparation system, this technology is the seed of innovation in blood testing.

InD's first application, ALT + AST liver indications, allows for at-home testing of drug induced liver injury (DILI) and extends the menu of blood gas analyzers used in emergency settings. It is not intended to capture the whole market, but rather fill holes in the market. Digital design tools make it possible to scale this spectrophotometer down in size to retrieve subsequently more information from a single drop of blood. This approach will eventually yield comprehensive blood panels on your phone, at home.

InD presents a unique approach to achieving exponential growth in blood testing. The current razor-razor blade business model simply doesn't work because customers need multiple razors to address their needs. Imagine buying a razor for your chin, a razor for your left cheek, and so on. The no-analyzer is the universal analyzer. Products launch with 100% install base by default and can extend the incomplete test coverage of existing analyzers effortlessly before addressing never before imagined use cases. Anyone in need and with a phone can become a customer without commitment, cost or inconvenience. It's the future of blood testing.