All EXOVEX products have undergone extensive molecular characterization including:
- PCR analysis to test for the presence of pathogens.
- Fluorescence Assisted Cell Sorting to specifically select Mesenchymal Stem Cells.
- Multidimensional Protein Identification Technology (MudPIT) to characterize and quantify the proteins present in the final specimen.
- Nanoparticle Tracking Analysis (NTA) to ascertain particle size and concentration.
The results of these tests and interpretation of the data is detailed below.
POLYMERASE CHAIN REACTION (PCR)
Each specimen was tested against an extensive panel of pathogens including HIV, Hepatitis B, Hepatitis C, HTLV, Syphilis, CMV, West Nile virus, Zika virus. This panel exceeds FDA guidelines for communicable disease testing in human tissue.
No PCR amplification was observed for any of the pathogens tested. The results of this analysis confirm that the starting material is free of all communicable diseases tested.
FLUORESCENCE ASSISTED CELL SORTING (FACS)
The cells were sorted using FACS to specifically select Mesenchymal Stem Cells prior to expansion. This level of analysis is not routinely performed prior to culture for Exosome production. All cells expressed surface molecules CD105, CD90, CD73 and CD146 and CD44 and lacked expression of CD45, CD34, CD31 and HLA-DR . This analysis confirms the presence of purified MSCs prior to culture resulted in a higher yield of exosome nanoparticles.
MULTIDIMENSIONAL PROTEIN IDENTIFICATION TECHNOLOGY (MUDPIT)
Two representative samples were submitted for MudPIT  analysis. Comparative analysis of each specimen demonstrated a high degree of inter-batch reproducibility. In Sample 1, 387 unique human proteins were identified from a total of 2665 peptide sequences detected. In Sample 2, 401 unique human proteins were identified from a total of 3914 peptide sequences detected.
All proteins detected in each sample were cross referenced against the UniProt database  for functional annotation to ascertain the potential efficacy of the EXOVEX samples by understanding the biological processes of their component proteins.
The predominant proteins identified in each sample tested are consistent between the different batches tested.
NANOPARTICLE TRACKING ANALYSIS (NTA)
Two representative samples were submitted for NTA. Both samples demonstrated exceptional particle counts indicating the effectiveness of the upstream processes, in particular the proprietary culture media and the fluorescence assisted cell sorting, for producing a high
potency final product.
Two complementary techniques for estimating the size and concentration of the particles in each sample were used :
- Dynamic Light Scattering which measures the intensity of fluctuations in scatteredlight.
- Fluorescent tagging where the particles are observed under amicroscope.