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Flush with funding and protected by a portfolio of patents for a novel technology that promises to break open a market for point-of-care (POC) diagnostics estimated at $11 billion, Ian Campbell is confident about the future of Molecular Vision (London).

After seven years developing a lab-on-chip platform that lends itself to a broad range of bedside diagnostics for cardiac, renal, diabetes and infectious diseases, the chief executive said the only blip on the radar is that he has just 18 months-worth of development time.

“In the short term, we have a unique platform,” he told Medical Device Daily with his rolling Scottish brogue. “But the window of opportunity to prove the concept and get to market is less than two years. There are a number of diagnostic players moving on this.”

Since 2004 Molecular Vision, a spin off from the Imperial College incubator Imperial Innovations (also London), attracted investments totaling $4.6 million from the Geneva-based group Acrongenomics for developing a combination of microfluidics and light-responsive polymers on a disposable diagnostic device.

In May 2006, Acrongenomics signed a follow-on $6.5 million joint development agreement with Molecular Vision.

Acrongenomics formally acquired 10.9% of the shares in the company (Medical Device Daily, Feb. 5, 2008) and one week later announced a full acquisition of Molecular Vision will be completed before the end of 1Q08.

“Having seen all the applications open to the device it is now appropriate for us to protect our initial investment and take total control over the rapid commercialization of this exceptional and versatile technology,” said Dr. Dimitris Goundis, CEO of Acrongenomics.

Molecular Vision’s unique platform promises to break the barrier that has so far stymied widespread use of POC diagnostics at the bedside or hospitals or a general practitioner’s office: the imposing cost of the instrument needed to read the low-cost, disposable plastic test slides.

While the chemistry, biological processes and electronics for lab-on-chip applications have been miniaturized in recent years to the micron, and even nano-scale, the machines analyzing the results from the test are often as large and just as expensive as the instruments used in traditional pathology labs.

In March 2007 at Imperial College, Molecular Vision demonstrated its BioLED (light-emitting diode) technology using microfluidics channels to pass a sample through embedded emitters and photo detectors for optical characterization of known biomarkers for kidney and cardiac disease using fluorescence, absorption, and chemiluminesence.

Pearson Matthews (Kingston Upon Thames, UK) signed on in June 2007 to design a commercial prototype and Molecular Vision in August received £500,000 ($983,000) from Imperial Innovations.

One year later, Campbell told MDD that Molecular Vision is ready to demonstrate a five-channel prototype of the device with two parallel urine-based assays for creatine and vitamin C to diagnose kidney function.

He said a third channel will be demonstrated in parallel later this year for microalbuminurea, a marker for diabetes patients who may have a failing kidney.

Clinical trials for the platform are scheduled for 3Q08/4Q08, he said, anticipating a milestone product approval before the end of 2009.

The end point for the clinical trial is demonstrating the analytical capabilities of a number of standard pieces of laboratory equipment can be duplicated in a simple to use compact hand held device.

The results of a comparative trial measuring creatinine in urine will put the software loaded on a personal digital assistant (PDA) against the results from Siemens DCA 2000 analyzer for diabetes management where a microalbuminuria cartridge provides results for both albumin and creatinine markers.

Campbell said Molecular Vision is targeting “a very wide range of diagnostic tests based on the same procedures used in the laboratory and making them available in a physician’s office.”

“There is the potential of completely revolutionizing the POC diagnostics market,” he said.

Goundis of Acrongenomics goes further with his predictions setting the market potential at $11 billion and saying “the true versatility of this device is such that the unit can be taken into the field, not only to support community based health initiatives, but also in homeland security and in the veterinary field for in situ testing of infectious disease.”

Campbell said product development has accelerated steeply since the 2007 demonstration with a 100-fold increase to detection sensitivity through a combination of optimized light sources, light detectors and filters, “all of which are assembled at low cost and ideal for the point-of-care diagnostic market.”

“We now need to show unequivocally that this system generates the same data with the same degree of accuracy as the standard laboratory based tests,” he said, adding “we have the advantage of using microfluidics, making the test portable in a stand-alone device with an integrate screen.”

While other POC developers are desperately seeking lowered manufacturing costs (MDD, Feb. 20, 2008) Campbell said his business model does not include the headaches of manufacturing.

“We are not proposing specific products because we will not be taking any products to market,” he said, explaining that the end game for Molecular Vision is a strategic partner to take a product to market, or else a sale of the company to a major international player with the manufacturing and distribution capabilities to exploit the technologies.