- Optiscan Imaging is seeking the legal sale in the U.S. of its technology targeting early stage oral cancer
- Its screening system claims to better access the oral tissue compared to conventional methods
- According to the Oral Cancer Foundation, there is a gap in detecting oral cancer early – meaning the U.S. may greatly benefit from deploying this technology
- Optiscan’s shares remain flat today, trading for 4.1 cents each
Optiscan Imaging has requested a meeting to the Centre for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA).
The company initiated the meeting request to seek feedback on its proposed content to support a 510(k) submission.
A 510(k) is a premarket submission made to the FDA to show the device is safe and effective.
Optiscan is seeking to target over 50,000 patients in the United States who were diagnosed with oral or oropharyngeal cancer this year.
The Optiscan system technology comprises laser scanning confocal miniaturised microscopes for in-vivo imaging of the internal microstructure of the tissue within the oral cavity.
Executive Chairman Darren Lurie is pleased with the company’s progress of its technology.
“This is an exciting step forward for the Company as we progress the application of Optiscan technology in oral cancer screening and/or surgery,” Darren said.
This news follows previously announced trials in oral cancer screening with the Memorial Sloan Kettering Cancer Centre.
An estimated 450,000 new cases of oral and oropharyngeal cancer are identified each year.
Conventional microscopes that are currently used sometimes encounter challenges when accessing the tissue of interest.
It is difficult to recognise early-stage oral cancer due to it appearing similar to non-cancerous wounds.
According to the Oral Cancer Foundation, there is no comprehensive program in the U.S. to screen for oral cancer and without that, discovering the disease in its late stage is more common.
Optiscan’s shares remain flat today, trading for 4.1 cents each at 3:36 pm AEDT.