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In the development of cancer drugs and drugs for autoimmune diseases, having a clear understanding of the populations of immune cells in a patient, and how they change over time, are key data. The process of counting specific cells types that are created via a human’s immune system is called immune cell profiling. Seeing more, or less, of specific immune cells can help researchers observe the mechanisms of a drug, the action of the drug, and the effects of a drug that is under clinical study.

Commonly, immune cell profiling is conducted using flow cytometry. Using this method, live cells are tagged with specific antibodies that bind to markers on the cell surface, a method of immunophenotyping that allows for the accurate identification and counting of a variety of immune cells present in a biospecimen.

While flow cytometry is still the current “gold standard” for immune cell profiling, it does have some shortcomings, especially in today’s clinical trials environment where clinical sites—and hence sample collection sites—are often spread among a dozen or more locations worldwide.

In order to use flow cytometry, the samples require skilled preparation at the collection sites. “In flow cytometry you need to do a very sophisticated pre-analytical process,” says Uli Hoffmueller, Vice President of Immune Monitoring Solutions with Precision for Medicine. “You need to pull the immune cells out of the blood and cryopreserve them so they stay intact and even alive.”

If the process isn’t done correctly, within a short window of time, the sample could be lost. And the more centers involved in a trial, even with labs trained in a standardized process, the bigger the challenges are for preparing the samples correctly for flow cytometry.

Leveraging epigenetics for cell profiling

An alternative method for immune cell profiling that uses epigenetic markers is now becoming more common, having now been used in more than 100 clinical trials. This epigenetic-based method promises easier sample collection, a streamlined process for conducting immune cell profiling, and a large selection of pre-validated markers

Two examples of custom Epiontis ID panels that can be easily designed using pre-validated markers.

Called epigenetic immune monitoring, the method to identify specific immune cells leverages proven qPCR technology preceded by a simple and automated sample preparation process. The consistency and standardization of qPCR for epigenetic immune monitoring lead to data with high reproducibility that can be compared both within and across studies.

Precision for Medicine has commercialized this approach, as a service called Epiontis ID, which allows investigators to create custom panels in any combination of more than 30 pre-validated cell types. “Having this portfolio, which we add to each year, means we can start running specimens right away in a clinical trial, there is no need for project-specific development and validation,” Hoffmueller notes.

Epiontis ID supports multiple sample types: saliva, naso- and oropharyngeal swabs; blood samples including whole blood, PBMCs, PAXgene blood, and clotted blood; and tissue samples including fresh, frozen, and FFPE.

Because of the high stability of DNA versus live cells, sample collection at clinical sites is as easy as drawing a tube of whole blood and storing it in a sample freezer. When it is time to analyze the samples, they are batched and sent on dry ice to Precision’s testing lab for analysis.

“The planning, management, and logistics of clinical trial samples is simplified with Epiontis ID and guarantees that all of the samples make it to the lab in a condition in which they can be processed,” Hoffmueller concludes. “And because we can batch from trial sites every couple of months, and we can submit results back to the sponsor quickly, it is more economical than flow cytometry—savings we pass on to our clients.”

For more information visit www.epiontis.com

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