SP-IRIS is one of the methods the supplier reports using to characterize Bio Xsomes. Request the full report and method rather than a summary count.
This approach is used in some extracellular vesicle characterization workflows alongside other methods such as nanoparticle tracking analysis and marker-based assays like ELISA. Reporting both a particle count and the specific markers particles were captured against gives more information than a count alone, since it ties the measurement to a specific identity claim rather than treating every detected particle as equivalent.
When a supplier includes SP-IRIS data in a characterization package, ask which markers the particles were captured against, since that determines what the reported counts actually represent, and request the full report rather than a single summary number. FDA states there are no FDA-approved exosome products; they are generally regulated as biologic drugs under section 351 of the PHS Act, and purchase and clinical-use decisions belong to the physician and their own regulatory counsel.
SP-IRIS ties particle counts to specific markers, giving buyers a more specific basis for evaluating a supplier's characterization claims than a raw particle count alone.