The Scanadu SCOUT, one well-known entrant in the Tricorder X PRIZE

The Qualcomm Tricorder X Prize posted the final guidelines, detailing how devices will be judged for the $10 million prize when evaluation begins in 2014. (Update: The group has since removed the final guidelines from its website and expects to officially release them when registration for the prize opens on January 8th.)

Sponsored by tech giant Qualcomm's philanthropic arm, the Qualcomm Foundation, the X Prize offers $10 million to the teams that can create the best handheld health scanner, similar to the medical tricorders seen in the Star Trek television shows. X Prize has gone as far as to license the trademarked term from CBS and has used several Star Trek fan events as publicity platforms for the prize, even recruiting Brent Spiner (Star Trek: The Next Generation’s Data) as a spokesperson.

The contest guidelines

When the first round of judging happens in April 2014, devices will be assessed based on information submitted by the teams and a controlled demonstration. The assessment will include both a consumer experience evaluation and a health assessment, each comprising 45 percent of a team’s score (the remaining 10 percent will be based on efficacy or feasibility data the team submits).

The consumer experience segment includes the device’s appearance, simplicity, the design and ease of use of the interface, and “engagement,” a category that tests the degree to which the device coaxes the consumer to begin and continue using it.

The health assessment consists of 13 core diseases, 12 elective diseases, and five vital signs the device should be capable of constantly monitoring. To pass the qualifying round, a device must diagnose at least 13 conditions, including five core diseases, one elective disease and three vital signs. In the final round, however, scanners will need to detect the whole core set, all the vitals, and three of the 12 elective diseases.

In the final round, held in Q1 2015, the devices will be tested in a variety of ways, including clinical tests on sick patients and focus group-like feedback from physicians and consumer users. Consumer testers will try out the devices over the course of three months between January and March.

The device also has to weigh less than five pounds, and can't rely on any input from medical professionals, like outsourcing to a medical call center. The winner will receive $7 million, the runner-up will get $2 million, and third place will get $1 million.

A supplement, not a replacement

X Prize director Mark Winter was clear that the X Prize team doesn’t see the eventual product as a replacement for doctors.

“We see this tool not as an interloper, but a valuable bridge,” he told MobiHealthNews. “We do not see this as a way to eliminate physicians from the process.”

The new guidelines, however, talk about de-skilling healthcare and reducing the role providers must play.

“[A]s our understanding deepens, the established system is being disrupted by innovations allowing us to more easily make reliable assessments that thus 'de‐skill' medicine,” the document reads. “Teams of highly skilled engineers operated the first computers, but today’s smart phones (which have infinitely more computing power) can be operated by a ten-year-old effectively. Why not healthcare?”

Winter said the two viewpoints aren’t inconsistent. He sees the tricorder driving down healthcare costs by eliminating unnecessary emergency room visits and hospital readmissions. The more easy diagnosis a machine can do, the less a doctor has to.

“If you contrast some of the early devices for taking blood sugar, they generated information that could only be understood by a physician or a nurse. And today we have consumer glucometers, which revolutionized the management of diabetes as a result,” he said. “What we're advocating is really no different.”

Teams are already at work

Registration opens January 8, but pre-registration has been open for some time. There are 255 teams pre-registered and they range, in Winter’s words, “from individual inventors and garage-based development groups, to middle funded startups to big companies.” The latter group includes some “big movers and shakers,” Winters says, who aren’t ready yet to publicly announce their involvement.

The company is also providing a framework for teams to merge and recombine rather than drop out of the competition. Next month they’ll be rolling out the Competitor Marketplace, an online bulletin board where teams can discuss possible collaboration.

One of the biggest challenges of the Tricorder X PRIZE is the large variety of conditions and vital signs the devices will need to monitor. The contest was designed to give equal chances to integration approaches – which adapt existing technologies into a new handheld form factor – and innovation approaches, which scan patients in totally new ways.

In the first category is one of the highest-profile entrants into the space, Scanadu, a company that was founded last year with the concrete goal of developing a consumer tricorder product, not just of winning the contest. Last month, Scanadu announced their product suite, the Scanadu SCOUT, Scanadu Flo and Scanadu Flo.  From what Scanadu has announced to the press, that technology is already close to meeting the prize’s qualifying guidelines.

Scanadu’s approach  involves integrating a lot of existing scanning technologies, which is not by any means as easy as it sounds.

"I would say the innovation is particularly on the algorithms," Scanadu CEO Walter de Brouwer told MobiHealthNews. "Algorithms that learn - how to make the device learn - and integration, because we are putting things together that have never been put together before."

Nanobiosym's Gene-RADAR

Cambridge-based Nanobiosym, has a more unified approach: scanning for disease at the most basic level – our DNA and RNA. Their Gene-RADAR platform uses body fluid samples like saliva or urine to analyze for DNA or RNA signature each infectious disease carries.

“Nanotechnology in my mind is the ability to probe and control matter, energy and information on a very, very small scale,” CEO Anita Goel told MobiHealthNews. “If we can control nature on a small scale we can have a profound effect on a larger scale.”

Goel says that even though Gene-RADAR requires fluid samples, it's still fairly non-invasive, because for many diseases the test will be as simple as spitting into the device. The Gene-RADAR is a platform; much like the Scanadu SCOUT, the company will sell a basic device and chips that look for particular diseases.

“For efficiency purposes you need a bit of a platform which is like a Christmas tree on which you can hang all the ornaments,” Goel said. “That’s key to have a platform. And then we have the idea of building different apps that give you the diversity that one may seek on top of the uniformity the platform gives you.”

Goel and her lab have been working on Gene-RADAR since before the prize was announced. Gene-RADAR 1.0 is already able to use a drop of blood or saliva to diagnose any disease or bacteria with a genetic fingerprint in about an hour, Goel told MobiHealthNews. The company is working on shrinking the device for future versions.

In addition to the home diagnosis and monitoring market, Goel is aiming at the global health market, as the device can diagnose diseases without constant electricity, running water, or highly trained personnel.

Montague Health's Virtual Scanning

Another highly-focused, if somewhat more unconventional, entrant is Graham Ewing’s Montague Healthcare, whose device will be predicated primarily on a new, not widely accepted kind of scanning called Virtual Scanning.

In Virtual Scanning, a patient watches a video with the colors altered, then uses a computer program to repaint the video based on their recollections. A complex set of equations applied to the speed at which the patient performs the test and the colors they choose can accurately diagnose a range of physical diseases and mental conditions, Ewing told MobiHealthNews.  Ewing says it’s the math that really makes it work.

“What we’re talking about in total is a technology that is the first mathematical model of a physiological system,” he said.

Ewing said Virtual Scanning is approved and used often in Russia and the Ukraine, but it has been very difficult to get the funds needed to clinically prove the therapy in the United States or his native England.

“It’s the regulatory issues that cause us such a problem, because we need to raise funds in order to conduct clinical trials,” he said. “The market is incredibly conservative and resistant to change.”

Ewing thinks his tech has an advantage because it’s a single scan that diagnoses for a wide range of pathologies.

“I don’t think anyone’s going to win this prize unless they have a fundamental technological concept. I don’t think they can win it by cobbling together a half a dozen different technologies into one package.”

Ewing thinks the test could be a big break for Virtual Scanning; an opportunity to show the world what the technology is capable of. He hopes to take advantage of the Marketplace to find a partner that can help with the engineering side.

“I think I can win it, I’m pretty sure I can win it,” he said. “I’ll get as close as anyone can. Whether we can win it will be determined by whether we get funding and whether we can put together a team that will build a box so we can put the label ‘Tricorder’ on it.”

Nanobiosym's Goel said that even though her company would have built its technology anyway, the prize is important for more than just fostering innovation.

“It’s not enough to have disruptive technology in our laboratory,” she said. “You have to build a community. The prize helps bring awareness about what people like us are doing, and it improves the broader landscape of healthcare and facilitates the adoption of quantum leaps into our healthcare landscape.”