Optiscan breaks silence with new clinical results

Melbourne-based Optiscan Imaging (ASX:OIL) has emerged from a quiet patch with the first results from a series of clinical studies using its flexible endomicroscopes.

The data -- from trials undertaken at Germany's Mainz University Hospital -- showed "outstanding results for the diagnosis of colon cancers" according to Optiscan.

"These results demonstrate that our flexible endomicroscopes can be used to improve on standard procedures to find and diagnose important diseases," said Peter Delaney, Optiscan's director of technology.

In both studies, the use of the Optiscan's miniaturised confocal microscope technology resulted in sensitive and specific diagnosis of early cancers and pre-cancers known as neoplasias. Detection sensitivities were rated at 94.4 per cent and 97.4 per cent respectively and overall accuracy of the microscope in predicting results obtained by conventional biopsies and histology was above 99 per cent.

"If you look at ulcerative colitis, it is very hard to know where to biopsy," said Optiscan CEO Matthew Barnett. "It should be significantly cheaper and quicker to collect the cellular-level information using the endomicroscope.

"What we find is that where multiple biopsies are recommended, typically that doesn't happen because of cost and patient discomfort. We're looking for a combination of time, cost and specificity, [which will mean] that the flexible endomicroscope is better than traditional biopsy. These results are very, very encouraging.'

Optiscan is developing the microscope jointly with Japanese company Pentax, the second largest player in the US$830 million global flexible endoscopy market.

Using the microscope, surgeons are able to view cell detail at a magnification of 1000 times compared with a magnification of 10 times in traditional endoscopes. Effectively, they are able to peer down into living cells, scrutinising cellular detail and detect abnormalities or disease states without the need for tissue samples to be excised surgically.

Results from the trials are to be presented at Digestive Diseases Week in New Orleans in May -- and will also be used to support Pentax's global sales release of the flexible endomicroscope system in the first half of this year. Further multi-centre studies are also on the cards, according to Optiscan.

"Now we've got some tangible data we're looking forward to getting the doctors enthused, and the initial round of interest from the teaching and research hospitals," said Barnett. "FDA and C-Mark approval for the flexible endomicroscope is still pending -- Pentax have been looking to get FDA approval in the first half of this year."

According to Barnett, the German trials are continuing and three other studies are also underway in Melbourne, Kyushu in Japan, and Pittsburgh in the US. No data is publicly available for the other trials as yet.

In February, Hong Kong-based JF Asset Management became the largest shareholder in Optiscan, acquiring 7,800,000 shares from Axon Instruments (ASX:AXN), representing 9.7 per cent of the capital of Optiscan.