Optiscan wins CE Mark approval, waiting on FDA

Optiscan (ASX:OIL) has received European CE Mark approval for its flexible endo-microscope, jointly developed with Pentax. But the company and its Japanese marketing partner Pentax are awaiting a go-ahead from the US Food and Drug Administration before the marketing process gets underway.

Company secretary Bruce Andrew said that Pentax holds the reigns when it comes to marketing the device to hospitals, although Optiscan plans to roll out around four more trial sites to gather data to support its efficacy claims. Currently the endomicroscope is being tested at eight sites.

"The clinical trial program is the critical part of the marketing process because it will provide the doctors with the information they need about going confocal," said Andrew.

In April, Optiscan was boosted by data from trials undertaken at Germany's Mainz University Hospital which showed "outstanding results for the diagnosis of colon cancers."

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.

"We expect FDA approval to come out fairly soon -- that's the signal for [Pentax] to start marketing," said Andrew. "They are unlikely to start marketing in Europe before they can do the roll-out in the US."

A response from the FDA is expected during November or December this year, although Andrew warns that "FDA timelines are notoriously difficult to predict".

The approval for the flexible endo-microscope was given by authorised European based independent agency TUV Rhineland, which audited Optiscan and Pentax for their respective quality systems and conformance to the requirements of the European Medical Device Directives.