NEW YORK (360Dx) – OptraScan said today that the Indian government has approved its whole slide digital scanner, following a validation study.
As a result of the approval, the company will work with several large hospitals and research networks to use a hub-and-spoke model to provide real-time access to slides and cases to pathologists, it said.
The approval follows a study that included 3,300 cases and 6,600 formal-fixed, paraffin-embedded glass slides at four sites representing metropolitan, urban, and semi-urban areas, OptraScan said. It added that the study demonstrated the scanner, also called OptraScan, is non-inferior to an optical microscope "for a vast majority of tissue specimens." The instrument had a mean percent agreement for image quality of 98.75 percent with a 1.5 percent discordant rate.
"By removing subjectivity in microscopy and replacing it with digital pathology, we hope to make cancer diagnosis more precise," OptraScan Founder and CEO Abhi Gholap said in a statement.
Based in Sunnyvale, California, OptraScan was founded in 2014 and offers a subscription-based service to pathologists who want access to digital pathology technology without having to pay the high instrument costs.