Until HemoGenix® launched its HALO® Platform for in vitro hemotoxicity testing in March 2002, drug development had to rely on either conventional hemotoxicity performed during regular pre-clinical animal studies or on the use of transformed cell lines which have little resemblance to fresh, primary cells.
Conventional hemotoxicity testing is performed as part of a list of toxicities that are required according to the guidelines of the regulatory agencies. Conventional hemotoxicity detects changes in circulating blood cell parameters and in morphology of the hematopoietic organs, e.g. bone marrow and spleen. Because many changes seen in the circulation are the result of actions that have occurred at the stem and progenitor cell levels of the blood-forming system at a much earlier time point, conventional hemotoxicity has no predictive value. If the same studies had been performed using HALO®, the effects found in the circulation could have been predicted without the use of animal testing, thereby saving considerable time and money.
Now it may be argued that in vitro assays are surrogate assays and do not provide the same information as a whole animal model or even a human patient. However, at HemoGenix®, our HALO® Platform was initially designed to use fresh, primary human bone marrow, peripheral blood or umbilical cord blood. The HALO® Platform has also been validated against the Registry of Cytotoxicity Prediction Model using fresh, primary human hematopoietic tissue and is therefore a validated cytotoxicity assay. We have also designed predictive paradigms of hemotoxicity that can be used for human, non-human primate, dog, rat and mouse. The HALO® Platform is the best assay available for predicting human hemotoxicity.
HemoGenix® offers 3 different HALO® Hemotoxicity Platforms for contract services and in-house testing.
HALO®-96 MeC (Methyl Cellulose) is similar to the traditional colony-forming assay in that it allows cells to grow under clonal conditions, but instead of manually counting colonies, an instrument-based, ATP bioluminescence readout is performed. The assay uses a 96-well plate format, but should really only be used for a small number of samples because the viscous methyl cellulose has to be dispensed manually. The HALO®-96 MeC Hemotoxicity Platform can be used for pre-clinical animal studies and patient monitoring during clinical trials.
HALO®-96 SEC (Suspension Expansion Culture) does not use methyl cellulose and therefore the whole assay, from beginning to end, can be performed under fully automated conditions. The HALO®-96 SEC Hemotoxicity Platform is easier to use at any stage of drug discovery and development, from screening to patient monitoring during clinical trials. It is also 2-3 times more sensitive than the HALO®-96 MeC Hemotoxicity Platform.
HALO®-384 HT (High-Throughput) is similar to the HALO®-96 SEC Hemotoxicity Platform, but uses a 384-well plate format. It was specifically designed for drug discovery screening at the ADME/Tox level and is even more sensitive than the HALO®-96 SEC Hemotoxicity Platform.
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Find out which HALO® Platform is right for you
For in-house hemotoxicity testing, HemoGenix® offers a large number of assay kit options.
Hands-On Training
HemoGenix® offers a comprehensive 2-3 day training course. During that time, you will learn the background of performing hemotoxicity testing using the HALO® Platform, you will get hands-on experience at setting up a complete experiment as well as how to process the plates and evaluate and interpret the results. You will have all the necessary experience to begin using the HALO® and our other ATP-based bioluminescence platforms.
We invite you to either train at our facility in Colorado Springs, Colorado, or we can train your personnel at your own facility. Call us for more information.