Guardian Technologies delivers fully automated tuberculosis detection system

Guardian Technologies International has joined forces with Prior Scientific and Olympus Soft Imaging to create and accelerate the integration of Guardian's SM TBDx software into an automated sputum microscopy system for detecting tuberculosis.

Guardian Technologies International announced that it has joined forces with Prior Scientific and Olympus Soft Imaging to create and accelerate the integration of Guardian's Signature Mapping diagnostic (SM TBDx) software into a first-of-its-kind, fully automated sputum microscopy solution for the computer-aided-detection of tuberculosis

A memorandum of understanding (MOU) between Guardian, The Aurum Institute for Health Research, and the South African National Health Laboratory Services (NHLS) established the objectives and product specifications to address the diagnostic challenges faced in South Africa. Conceptually, the MOU established a pathway to deployment of SM TBDx focused on retrofitting existing microscopes with digital cameras

SM TBDx's 92.86% accuracy in positive cases and 3.75% false positive field of views, in the November 2009 clinical trials, exceeded the NHLS program objectives of 80% accuracy and no more than 20% false positives, as well as industry norms of less than 70% accuracy.

SM TBDx's performance prompted a request by NHLS to additionally address the growing challenge of sputum slide processing and diagnostic throughput, an ever increasing challenge in South Africa and the other 21 countries with high burdens of TB. Worldwide estimates indicate 100 to 150 million slides are processed and analyzed by laboratory technologists annually with volumes growing at estimated double digit rates per annum.
The fully integrated SM TBDx system to be delivered initially to South Africa, and then beyond, will be capable of 24/7 slide processing that will require little human intervention while maintaining highly accurate diagnostic results. An additional benefit of this system will be that highly skilled laboratory personnel will be able to focus more attention on the most difficult cases, rather than reviewing every slide.

"For decades, the world has needed a more accurate, low cost, fast TB diagnostic solution -- particularly one that can accurately diagnose early stage TB and TB in HIV-positive patients -- in centralized laboratories and at the point of care. Guardian's Signature Mapping TBDx is the answer," said Rich Borrelli, VP of business development for Guardian's Health Division. "The product offerings of the SM TBDx fully automated and manual retrofit systems position Guardian to address the full range of diagnostic environments. Furthermore, SM TBDx's advanced image analysis integrated with automation positions Guardian to immediately address the worldwide crisis in TB detection."

The enhanced requirement of NHLS for the fully automated diagnostic solution delayed the Phase 2 (final) clinical trial in S. Africa to later this month. This scheduled delay is necessary to fully oblige the requirement for the automation integration, as well as planned commercialization and rollout of the system to South Africa's 240 laboratories upon successful completion of the trial.

Guardian is currently in negotiations for the sale and deployment of the initial three systems in South Africa that would be used in support of the Government's Recheck Program and to support tuberculosis research at the Department of Microbiology, NHLS, at the University of Pretoria. Guardian expects to soon announce a distribution/reseller agreement with a South African healthcare company for SM TBDx distribution in Africa, within South America, Indonesia, and Australia.

The fully automated slide management and detection system has major implications for TB programs in heavily burdened countries like India, Russia, and China, which handle extremely large and growing volumes of slides. As part of Guardian's international marketing strategy, SM TBDx is being modified to address a different staining method and microscope lighting source as used in most of the world. Indian health officials have directly communicated an interest in a fully automated TB detection system to handle its estimated 35-40 million slides per year.

To further penetrate the world TB diagnostic market, Guardian's SM TBDx product offerings will be expanded to provide diagnostic solutions at large centralized laboratories or hospitals (fully automated system), smaller local laboratories in rural areas (retrofit system), and mobile labs to provide 100% screening of the population in the most remote of areas.

Posted by Vision Systems Design

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