CDEX shipped the first ValiMed™ G4 drug validation system to a prominent US based global medical technology company. The company intends using the ValiMed G4 as a lab instrument for a research and development project to determine the shelf life of parenteral admixtures with regards to potency over time.
Perhaps that ValiMed G4 system user manufactures pre-mixed parenteral drugs, or compounded drugs in various forms, in various types of containers. Perhaps they are seeing if potency of the drugs change over time based upon temperature and storage variables. Perhaps they are testing potency of the drugs in multiple container types to measure any change in potency over time. That global tech company could be doing project work that is monitoring potency changes (or the lack thereof) based upon all sorts of variables.
Frankly, the ValiMed G4 system is described in terms that indicate it can be valuable and useful as a laboratory device or a way to provide immediate presumptive results prior to doctors or pharmacists etc. sending a sample off for lengthy and expensive gas chromatograph / mass spectrometer testing. Again, I know first hand that using that equipment TYPICALLY presents the problem of extended turn-around times (like, DAYS) and the cost can be prohibitive.
Even the earlier generation ValiMed provided that type of service. While speaking with a Univ of Michigan pharmacist (now a PharmD), I was told a child was not responding as expected to a drug being administered. The doctor wanted to determine if the drug and concentration were indeed what had been ordered. The ValiMed system was at hand, they got immediate results confirming/validating the drug and concentration. Even if one says this could be described as a presumptive test, it is incredibly valuable. Nothing like it is available elsewhere. With the ValiMed G4 having a pay-per-use business model, this could be adopted by many very quickly. The ValiMed G4 is significantly superior to the earlier generations. The signature database would not be limited to drugs that fluoresce. The analysis would not require containers to be opened and a sample extracted for testing. I strongly suspect the specificity and accuracy will be significantly improved via the Raman, Fluorescence, Reflective processes discussed earlier.
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