Park City, Utah
CEO Bill Olson is looking to revolutionize testing for infectious diseases with a point-of-care solution that might just upend the decentralized lab-based model.
Dr. Brian Caplin started the company in 2003 working in PCR -- Polymerase Chain Reaction -- was entrenched as the status quo in molecular testing for the presence of DNA -- to look for Ebola, the flu, or most anything else.
"It's kind of the golden rule of DNA amplification," Olson says. PCR amplifies DNA so that a few strands become billions, he explains, and one pathogen molecule is no longer a needle in a sample's haystack. After PCR, the sample "becomes a needlestack."
However, since it usually requires an hour for the test, it's handled by decentralized labs, Olson adds. "That's not fast enough to get it to the point of care."
But Caplin's XCR needs only six minutes. Dubbing it the "holy grail of diagnostics," Olson says that's a huge breakthrough for several reasons. It has massive implications on the spread of disease, he notes. "Long before you're symptomatic, you can detect Ebola."
It's also much less expensive than PCR -- and more accurate. It also makes for less antibiotic prescriptions, as they're often passed out preventively before test results come in, making them less effective in the long run. "We've developed a great deal of drug resistance," says Olson.
Fluoresentric got its first patents for XCR in 2010 and now has 10 patents -- "We have more patents than employees," Olson quips -- with every last claim approved by the U.S. Patent and Trademark Office.
The company has built a handheld device that is orders of magnitude less expensive than PCR counterparts. Olson says it's about $200 versus $50,000, and has launched an instrument company to develop the devices.
It also uses much smaller samples and is more efficient. "We have an efficient chemistry that's more like a drone strike than a nuclear bomb," he says. "It's pretty hard to believe the simplicity of our chemistry."
After regaining control over the intellectual property and recapitalizing the company, Fluoresentric is poised to disrupt the $80 billion market for infectious disease testing in the near future, Olson says, and move DNA amplification from decentralized labs to doctor's offices and clinics. He says it's reminiscent of decentralization in energy and computing, two other industries where he's worked in the past.
But first the technology has to make it through FDA trials Olson expects will start in late 2015. The agency could approve XCR by mid-2016 and point-of-care testing could begin by the end of the year.
The company has already entered industries that are not FDA-regulated, including cattle, medical marijuana and food safety. "It's much lower regulation than human diagnostics," says Olson.
Challenges: "To get this chemistry to human diagnostics," says Olson. "It requires FDA trials that are extremely burdensome and expensive."
"Our challenge over the next four to six months is to execute." He says that includes manufacturing about 20 handheld units for testing.
Opportunities: Rapid growth in a multi-billion-dollar market. "If we execute properly, we anticipate a $1 billion valuation in two years," says Olson. He thinks the staff could more than quadruple to 40 by mid-2016. "There's a great deal of interest in this company," he says.
Needs: "Capital," says Olson. After closing on $1 million from an investment bank in November 2014, Fluoresentric needs a round of $5 million or more by the end of 2015 and maybe $15 million more in 2016. "That will get us to a $500 million valuation."