With it, doctors working in remote locations could diagnose a disease on site. Forensics workers could use it at a crime scene to determine time of death. The Department of Defense could use it to ascertain whether a mysterious white powder is anthrax—or something more innocuous. Food companies could use it to identify E. coli outbreaks. And someday, mothers might use it to determine whether their kids are suffering from strep throat or allergies. “There are a billion smartphones on the planet today, and each one is potentially a lab point,” Perelman says.
The Department of Defense could use it to ascertain whether a mysterious white powder is anthrax—or something more innocuous. Food companies could use it to identify E. coli outbreaks.
But the field of distributed diagnostics has traditionally been controversial. The most infamous example is 23andMe, a promising startup that marketed $99 at-home genetic tests, before the FDA served it a cease and desist letter because the company was operating without proper approvals. Then there are the slew of unregulated and, in some cases, fraudulent medical apps facing the wrath of both the medical community and the FDA. To succeed, Biomeme must prove its creation is not another scammy stab at digital health, but a carefully vetted and legitimate revolution in diagnostic technology.
“If their technology works, the sky’s the limit,” says Chris Laing, vice president of science and technology at the University City Science Center, an incubator where Biomeme is currently developing the product. “But whenever you take a well-validated technology that people think belongs in the lab, there’s always a hurdle demonstrating the field version is as good as the lab version. That’s going to be one of their primary challenges.”
Biomeme co-founders Jesse van Westrienen, a trained biologist, and Marc DeJohn, an engineer, conceived of the idea while working together at a New Mexico startup that was developing its own diagnostic tests. According to Van Westrienen, they began thinking about all the ways mobile phones have changed our world and wondered why, with all their computing power, the devices had not yet changed the world of diagnostics. “We thought it made total sense to build diagnostic testing around the smartphone, so we quit our jobs and started doing this,” he says.
But that wasn’t all they hoped to achieve. Van Westrienen and DeJohn also wanted to build an open platform other researchers could use to develop diagnostic tests. It’s a novel idea in the scientific community, where most diagnostics developers build the hardware, software, and tests themselves, then lock them up with patents. As a result, Van Westrienen says, “there are thousands of these tests sitting in freezers that academics developed, and half the time, they die in freezers and never get applied.
Like Uber or Airbnb, we wondered, how do we take a resource that’s sitting fallow and use it to our advantage?”
‘Like Uber or Airbnb, we wondered, how do we take a resource that’s sitting fallow and use it to our advantage?’ So Van Westrienen and DeJohn recruited Perelman to lead the business. Together they set about developing a diagnostic tool any researcher could understand, and even a layman could someday use. Today, the technology looks like a souped up smartphone dock. It’s called a thermal cycler, similar to those currently used in labs around the world, except smartphone-sized. It latches on to the back of an iPhone. The thermal cycler comes with its own sample prep kit-–-a series of color-coded tubes and pipettes—that includes everything you need to prepare a DNA or RNA sample.
After a sample of, say, urine has been prepped, it is inserted into the top of the thermal cycler, which uses a process of heating and cooling to identify the presence of a certain DNA or RNA strand for, say, the flu. If the flu is present in the sample, the thermal cycler will multiply the RNA strands, and they’ll begin to glow. If it’s not present, the thermal cycler won’t be able to multiply it, and therefore, the sample will not glow. The machine would then use the smartphone camera to measure the luminosity of the sample and determine whether the flu was present.
If it sounds complex, that’s because it is. And yet, Biomeme has masked this complexity with dead simple design that enables anyone to take its test kit out of the box and use it, regardless of whether they have experience using PCR technology. To prove this point, Perelman recently recorded his 7-year-old daughter giving it a try.
The Path of Least Resistance
Biomeme is currently developing its own test for sexually transmitted infections; it is undergoing clinical trials at Drexel University in Philadelphia. But it may be a while until such a test is commercially available in the United States. After watching the public and costly mistakes of companies like 23andMe, Perelman knows Biomeme would be in a sticky position with regulators if he began marketing the technology as a medical device. Rather than waiting for FDA approval or risk its wrath, Biomeme plans to launch its human health tests overseas, where the regulatory environment is less strict. The company already has a partnership lined up with The Gorgas Institute in Panama, a major public health research center.
Perelman knows Biomeme would be in a sticky position with regulators if he began marketing the technology as a medical device. Then, once Biomeme has proved the sensitivity and efficacy of the technology overseas, Perelman hopes to have a smoother time gaining approval in the United States. “I’ve learned not to make strong claims about genomic testing,” he says. “It’s a field that’s still developing and these tests may be very accurate, but we’re still learning about that that means in terms of predisposition to disease.”
For now, the company is taking the path of least resistance, working with researchers in a variety of more loosely regulated industries, like food safety and environmental air quality, to develop and validate tests it could commercialize faster. “We don’t want to be the scientists in the ivory tower spending $10 million in 10 years developing the next sophisticated lab on a chip kind of thing. We wanted to get to market very fast,” Perelman says. “We want to be a community of users exploring the biological world, and that means an open platform that puts the power in the community’s hands.”
source: wired.com By Issie Lapowsky