mBio developing device for medical diagnostics

BOULDER – mBio Diagnostics, a subsidiary of Boulder-based Precision Photonics Corp., is developing a product that may drive down some health-care costs.

For the past two years mBio has been working on a low-cost, high-sensitivity medical diagnostic system to detect multiple pathogens, infectious diseases, and respiratory, cardiac and allergy complications.

By reducing the need for lab work and lab instruments, mBio is hoping to supply medical professionals around the world with the mBio instrument.

“One of the motivators for us is that we can make it so inexpensive that we can take it to any laboratory as well as developing countries with the intent that this can be used in a resource-limited setting,´ said Chris Myatt, founder and chief executive of both Precision Photonics Corp. and mBio Diagnostics.

Precision Photonics specializes in sensitive detection, precision measurement and laser technology. It has provided the technology base and technologists for mBio’s research and development for the past two years. Myatt won’t reveal the name of the product because of patent constraints, but he refers to it as the mBio instrument.

The instrument is similar in some respects to a diabetic-testing kit, Myatt said. “You have the test strip that goes with the reader. You put your blood on the test strip, the test strip goes in the instrument, and you get instant results.”

The mBio instrument will require health professionals to collect a testable sample with a cartridge in the same way a diabetic would use a glucose test strip. The cartridge is inserted into the instrument, and the health professional obtains results within minutes.

The cost of the instrument “as is” in a research setting is $600, but Myatt predicts that the marketed instrument, which will potentially be the size of a cell phone, will be inexpensive.

“We’ve been pushing technology to virtually make the instrument almost disposable. It is so cheap that it is effectively free because we want to be successfully selling the test cartridges,” Myatt said.

The cartridges produce a series of dots used to diagnose patients. In the simplest form, if the dots light up it means the patient is infected. mBio has successfully tested this in a clinical study with blood donated from a blood bank.

Compared to the current medical diagnosis procedures, the mBio instrument has potential beyond cost.

“We’re taking our sensitive precision technology into bio detection, and the most interesting application that we see is in medical diagnostics,” Myatt said. Not only will clinics have the ability to have immediate results, but the mBio instrument also detects the progression of a disease.

“You can tell whether you were recently infected,” Myatt said. “Knowing where you are in the disease progression is very important. The gradations of the dots that light up are intended for us to see where you are in the progression of the disease.”

mBio received its funding through a number of National Institute of Health programs. The subsidiary has received more than $5 million for research and development and is seeking funding for FDA submission and market distribution.

Myatt’s research team has collaborated with the Infectious Diseases Department at the University of California at San Diego as well as countries such as Brazil, Kenya and Peru. Myatt said mBio will have two trial instruments released as early as this summer to Brazil and UCSD.

“Our goal is to sustain a company with worldwide distribution of this diagnostic technology. I feel there could be a very substantial operation here in the Boulder area.”

Worldwide distribution is important for countries that lack centralized labs and medical resources. “This will be faster, better and cheaper for those countries that will never really have that option,” he said.

For more-developed countries, the mBio instrument can be used in addition to what the medical field has.

“I could put one of our instruments in an ambulance, which gives them vital cardiac information as they arrive at the ER,” Myatt said. “We don’t have all of the kinks worked out, but we consider ourselves on the path to getting this on the market. If this is successful we see a company that revenues $300 million to $500 million a year. We want to bring the sensitivity to the user without making them pay for that extra precision.”

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