i.Mune™ PID* (in development)


i.Mune™ PID* is a quantitative test to determine the percentages and absolute** counts of human

CD3+, CD4+, CD8+ T-, B-, NK cells, TSDR+ regulatory T cells, neutrophils and monocytes in peripheral whole blood or in blood dried on filter paper.

Allows molecular quantification of:

  • Overall T cells (CD3+)
  • Helper T cells (CD4+)
  • Cytotoxic T cells (CD8+)
  • B cells (CD 19+)
  • NK cells (CD16+ CD56dim)
  • TSDR+ regulatory T cells (Treg)
  • Neutrophils
  • Monocytes

TSDR = Treg Specific De-methylated Region

 


Results are comparable to flow cytometry

Comparison of immune cell quantification by flow cytometry and epigenetic qPCR in whole blood samples of healthy donors (n=25). Top: Relative quantification (% cells); bottom: Absolute quantification (cells/μl) (Baron et al., Sci Transl Med. 2018)
Comparison of immune cell quantification by flow cytometry and epigenetic qPCR in whole blood samples of healthy donors (n=25). Top: Relative quantification (% cells); bottom: Absolute quantification (cells/μl) (Baron et al., Sci Transl Med. 2018)

Comparison of immune cell quantification by flow cytometry and epigenetic qPCR in whole blood samples of healthy donors (n=25)

Top: Relative quantification (% cells); bottom: Absolute quantification (cells/μl)1)


Can be useful for**:

  • Early detection of immune cell dysregulation in patients with symptoms of primary immunodeficiency and immune regulatory disorders
  • Monitoring of patients with primary and secondary immunodeficiency and immune regulatory disorders under therapy

 

Primary Immunodeficiency diagnostic tests were recently included in WHO's Essential Diagnostics List (EDL), published 09 July 2019

*i.Mune™ PID is for research use, only and has not been registered as an IVD product and has not been approved or cleared by a regulatory authority.

 

**The above clinical applications have been established using technologies currently being employed in clinical laboratory routine (e.g. flow cytometry). Epimune has demonstrated equivalence of its epigenetic immune cell quantification method to flow cytometry (in whole blood) and the concordance of epigenetic immune cell quantification between whole blood and dried blood spots1)

Literature

  1. Baron U et al. Epigenetic immune cell counting in human blood samples for immunodiagnostics. Sci Transl Med. 2018 Aug 1;10 (452)
  2. Cepika AM et al. Tregopathies: Monogenic diseases resulting in regulatory T-cell deficiency. J Allergy Clin Immunol. 2018 Dec;142(6):1679-1695
  3. Second WHO Model List of Essential In Vitro Diagnostics (https://www.who.int/medical_devices/publications/Second_WHO_Model_List_of_Essential_In_Vitro_Diagnostics/en/) 
  4. Modell et al. Global report on primary immunodeficiencies: 2018 update from the Jeffrey Modell Centers Network on disease classification, regional trends, treatment modalities, and physician reported outcomes, Immunol Res. 2018
  5. Condino-Neto and Espinosa-Rosales, Changing the lives of people with Primary Immunodeficiencies (PI) with early testing and diagnosis, Front. Immunol. 2018, 9:1439
  6. Expert recommendations for better Management of Primary Immunodeficiency (pID) http://www.worldpiweek.org/resources/key-policy-documents
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