i.Mune™ NEO* (in development)

i.Mune™ NEO* is a molecular test for relative quantification (%) of human CD3+T-, B-, NK-cells, TSDR+ regulatory T-cells and neutrophils in dried blood spot (DBS) samples.

i.Mune™ NEO* is suitable for epigenetic quantification of:

Total T cells (CD3+)
B cells (CD19+)
NK cells (CD16+ CD56dim)
TSDR+ regulatory T cells
Neutrophils

TSDR = Treg Spezifische De-methylierte Region

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Epigenetic immune cell quantification allows early detection of inborn errors of immunity in newborns.

Identifizierung von Neugeborenen mit Severe Combined Immunodeficiency (SCID) und X-Linked Agammaglobulinämie (XLA) durch epigenetische Quantifizierung von T-, B- und NK-Zellen in Trockenblutproben (Baron et al., Sci Transl Med. 2018)

Vergleich der epigenetischen Quantifizierung mit dem kombinierten TREC/KREC Screening Test zur Identifizierung von Neugeborenen mit SCID bzw. XLA (Baron et al., Sci Tranl Med, 2018)

Nachweis von quantitativer Treg Dysregulation in Patienten und Neugeborenen mit IPEX Syndrom (Barzaghi et al., 2012; Baron et al., 2018)

Nachweis quantitativer Dyregulation von Neutrophilen in Trockenblutproben von Neugeborenen mit schwerer kongenitaler Neutropenie (Baron et al., 2018)

A cohort of 250 apparently healthy newborns and 24 confirmed SCID and XLA cases was analyzed using epigenetic immune cell quantification of T-, B- and NK Zellen in dried blood spot samples1)

23 out of 24 confirmed SCID or XLA cases were correclty identified using the epigenetic immune cell quantification method.

Using combined TREC/KREC Analysis, 22 out of 24 cases were correctly identified1)

Epigenetic quantification of regulatory T-cells (Treg) shows quantitative dysregulation in patients and newborns with IPEX Syndrome2)

Quantitative changes in neutrophils are detected in newborns with severe congenital neutropenia (SCN) using epigenetic immune cell quantification. 1)

Possible applications**:

Early detection of immune cell dysregulation in newborns
Confirmation of a conspicuous SCID screening result in newborns

*i.Mune TBNK 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.

**Die above possible clinical applications are currently tested in several studies

Literature

Baron U et al., Epigenetic immune cell counting in human blood samples for immunodiagnostics. Sci Transl Med. 2018 Aug 1;10 (452)
Barzaghi F et al., Demethylation analysis of the FOXP3 locus shows quantitative defects of regulatory T cells in IPEX-like syndrome. J Autoimmun. 2012 Feb;38(1):49-58
Cepika AM et al. Tregopathies: Monogenic diseases resulting in regulatory T-cell deficiency. J Allergy Clin Immunol. 2018 Dec;142(6):1679-1695