Applied Visual Sciences, Inc. (APVS)

[*MARINE 1*]

Guardian Technologies to Begin Phase II Clinical Trials of Signature Mapping TBDx(TM) TB Diagnostics

HERNDON, VA and JOHANNESBURG, SOUTH AFRICA -- (Marketwire)
05/19/10
Guardian Technologies International, Inc. (OTCBB: GDTI) has returned to South Africa to complete the clinical evaluation of the Signature Mapping TBDx? (TBDx) integrated, fully automated slide management and TB detection solution. The clinical evaluation will be conducted in collaboration with the Aurum Institute for Health and under the supervision of the South Africa National Health Laboratory Services (NHLS) -- TB Program. It is expected that preliminary results will be available prior to month's end. However, fully documented results and analysis reports will take several additional weeks.

While accurate detection remains the most critical component of any tuberculosis diagnostic solution, it alone cannot address the magnitude of the worldwide TB pandemic. South Africa and other highly burdened countries must find a solution to the secondary challenge of the growing volume of sample slides compounded by limited highly skilled technical and financial resources.

"Guardian's TBDx solution addresses these challenges by providing the first-of-its-kind fully automated slide management and TB detection system capable of screening large volumes of stained sputum slides without human intervention," stated Rich Borrelli, Guardian's Healthcare Vice President. "Guardian's research and development teams have accomplished this groundbreaking product without sacrificing the 92% detection sensitivity and 3.75% false positive rate experienced in the Phase I clinical trial."

The TBDx solution combines Guardian's highly sensitive and specific image analysis software with an automated slide loader capable of processing 200 slides without human intervention, a bar code reader, an automated microscope stage navigator to process the slide through the capture of 100 fields of view (FOV), and an auto-focus camera to digitally capture each FOV. Guardian has developed the software code to manage and synchronize the hardware components for hands-free slide acquisition and TB detection analysis. To view a video of the TBDx automated solution, please click on the following link

It is expected that the successful completion of this Phase II clinical trial will launch contract negotiations with the South African government for commercialization and rollout of the TBDx system to their laboratories, as well as establish the platform for the distribution of TBDx throughout all of sub-Saharan Africa.