© 2020 LibiPharm
SMARTube
New supporting technology for detecting antibodies to covid19, HIV and HCV at the stage of the "serological window"
Introduction
SMARTube is offering a new approach to serological diagnostics of infectious diseases – a major public health issue.
False positives, false negatives and inability to determine stage of infection represent a true handicap in accurately diagnosing hundreds of millions of people annually and thus constitute a major unmet medical need. The company develops unique products called SMARTube™, which are blood sample processing devices for improving specificity and sensitivity of serological assays for infections such as: HCV, HIV, COVID19, HBV, XMRV, CMV, HTLV-1, Chagas, Tuberculosis, Zika, Ebola, Borrelia and others, reducing the health costs and the spread of the diseases by identifying false positive and false negative diagnosed patients in hundreds of millions tests a year.
Current serological assays suffer from non-specific reactions leading to high false positives, indicating on infection while it does not exist. On the other hand, the assays suffer from a relatively low sensitivity, unable to detect infections weeks or months until the antibodies against the viruses (such as HCV, HIV and others) reach a detectable level (the "window period"). In addition, it is impossible for current serological assays to distinguish between a false positive, recent or chronic infection and viral cleared/resolved infection. Thus, current methods require repeat serological tests, in addition to the virus direct nucleic acid testing (NAT) causing unnecessary expenses and loss of valuable time that is needed for proper therapeutic and other clinically related decisions.
The SMARTube™:
The SMARTube is a blood sample processing device containing a proprietary activation media for the stimulation of antibody production (In-Vitro). It is a complementary product for improving performance of standard serological assays by reducing the rate of both false positive and false negative results. SMARTube enables detection of infections during the "window period" (when the standard serology is negative), enables validation of a positive infection and also effectively distinguishes between various stages of infection: acute, chronic, active or viral cleared/resolved infection (be it spontaneous or drug elicited), while the standard serological test cannot produce this information.
The SMARTube is based on the company's proprietary platform technology, Stimmunology™ allowing the growth and differentiation of primed lymphocytes (sensitised lymphocytes that have been exposed to the virus) that are present in the patient's whole blood sample. It includes an activation media in which whole blood lymphocytes are stimulated to produce virus specific antibodies in-vitro within days. The Stimmunology is overcoming the immune suppression of the body and thus, antibodies which were not present or detected in the original sample would be present and detectable in the enhanced samples following the Stimmunology incubation.
The Products:
SMARTube has developed three products: SMARTube™HCV, SMARTube™HIV and combined SMARTube™HIV&HCV. The company conducted clinical trials with these products in various countries around the world (such as USA, Israel, Russia, China, South Africa, Kenya, Mexico and Confidential 3 others). The results of these clinical trials have been published in both peer-reviewed journals and international conferences. The products' effectiveness was clinically proven in various serological assays, enabling its integration with any serological assay. The SMARTube™ HIV&HCV has received the CE mark as well as regulatory clearance in several other countries. The SMARTube™HIV is currently in regulatory clearance process with the US Food and Drug Administration ("FDA"). SMARTube works in collaboration with prominent academic institutes such as the University of Maryland and New York University as well as with the U.S Military and other governmental health organizations.
SMARTube has developed three products: SMARTube™HCV, SMARTube™HIV and combined SMARTube™HIV&HCV. The company conducted clinical trials with these products in various countries around the world (such as USA, Israel, Russia, China, South Africa, Kenya, Mexico and Confidential 3 others). The results of these clinical trials have been published in both peer-reviewed journals and international conferences. The products' effectiveness was clinically proven in various serological assays, enabling its integration with any serological assay. The SMARTube™ HIV&HCV has received the CE mark as well as regulatory clearance in several other countries. The SMARTube™HIV is currently in regulatory clearance process with the US Food and Drug Administration ("FDA"). SMARTube works in collaboration with prominent academic institutes such as the University of Maryland and New York University as well as with the U.S Military and other governmental health organizations.
© Libi Pharm Ltd, 2021.
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All materials on this site are protected by copyright.
It is prohibited to copy, distribute (including by copying to other sites and resources on the Internet) or any other use of information and objects without the prior consent of the copyright holder.
