Mass Validation Study of OptraSCAN Digital Pathology Leads to Approval by Government of India
Largest digital pathology study to date, analyzing and validating over 6600 FFPE slides, yields an approval for the use of OptraSCAN® whole slide scanners in India medical settings
SUNNYVALE, CA–(BUSINESS WIRE)—OptraSCAN today announced it has successfully completed the mass validation of its whole slide digital scanner OptraSCAN® with the support of India’s Biotechnology Industry Research Assistance Council (BIRAC), and approval from the Government of India, to begin implementing digital pathology nationwide.
This study is the largest to date of a pathologist’s ability to assess histopathology samples on a digital pathology whole slide scanner, comparing them to the output of a microscope. The study showed that the OptraSCAN device is non-inferior to an optical microscope for a vast majority of tissue specimens. The mean percent agreement assessed for image quality of 98.75, and similar 1.5% discordance rates, was in-line with the findings of recently published literature1,2,3.
Study Details
The study covered the full spectrum of histopathology specimens including special stains and immunohistochemistry workup. Case selection was performed targeting every subspecialty of anatomic pathology reporting and included 3300 cases and 6600 FFPE glass slides at 4 study sites representing metros, urban and semi urban areas. The study was conducted at different geographical locations covering referral laboratories, academic institutions and private laboratories, which included laboratories accredited by the National Accreditation Board of Laboratories. Scanners were deployed at different geographical locations in western Maharashtra, semi-urban eastern Maharashtra and North India.
“I have seen the OptraSCAN device in action and participated in the validation of the whole slide scanner. The results are very encouraging, and I am impressed with the technology and price, which will surely be beneficial for easy adoption of digital pathology,” said Dr. Bageshri Gogate, Professor and Head of the Department of Pathology, Central Clinical Laboratory, SMT Kashibai Navale Medical College and General Hospital, Pune, India.
“It was a great experience to work on the validation project,” said Dr. Sujit Joshi, Consulting Oncopathologist, Deenanath Mangeshkar Hospital, and OncoSight Diagnostics. “The image comparison of the OptraSCAN device with the light microscopy images is satisfactory, with the biggest advantage being able to run image analysis in the same setting.”
“We are poised to do away with the 150-year old optical microscopes and bring in much-needed objectivity in pathological diagnosis and research,” said OptraSCAN Founder and CEO Abhi Gholap. “By removing subjectivity in microscopy and replacing it with digital pathology, we hope to make cancer diagnosis more precise. Soon multinational companies will license the technology from us, and this will greatly benefit people on a mass scale.”
With this government approval in hand, OptraSCAN will be working with several large hospital and research networks to deploy a hub and spoke model, providing pathologists real-time access to slides and cases, and deliver rapid patients results.
About OptraSCAN
OptraSCAN® (www.optrascan.com) RUO, is the first On-Demand Digital Pathology® System to serve as the perfect tool for transition from conventional microscopy to Digital Pathology for the effective acquisition of whole slide images, viewing, storing, sharing, consulting, analysis and management of digital slides and associated metadata.
OptraSCAN On-Demand Digital Pathology® system includes a small-footprint, low and high throughput WSI scanner OptraSCAN® (for brightfield, fluorescent and frozen sections/live view mode), an integrated image viewer and image management system ImagePath® and telepathology TELEPathTM, CLOUDPath® cloud-based LIMS, image analysis OptraASSAYSTM and CARDSTM (computer aided region detection system), and includes up to 10 TB of complimentary cloud storage. Focused on delivering fully integrated, affordable Digital Pathology solutions, OptraSCAN provides a complete whole slide image solution system via an On-Demand pay-per-use model or outright purchase. Follow OptraSCAN on Linkedin and Twitter.
References:
- David R J Snead,Yee-Wah Tsang et al Validation of digital pathology imaging for primary histopathological diagnosis. Histopathology 68. 2016 , 1063-1072.
- Arnold M A et al The college of American Pathologists guidelines for whole slide imaging validation are feasible for pediatric pathology: a pediatric pathology practice experience. Pediatric development Pathology. 2015 Mar-Apr, 18; 109-16
- Thomas P.Buck et al Validation of a whole slide imaging system for primary diagnosis in surgical pathology: A community hospital experience. Journal of pathology informatics April 2015;5:43
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