NEW YORK — German diagnostics firm Epimune said last week that it has signed a Latin American distribution deal for its I.Mune TBNK lymphocyte quantification test with Tanner Pharma unit TannerLAC.
I.Mune TBNK is a PCR-based test designed for the epigenetic quantification of CD3+, CD4+, CD8+ T-, B-, and NK lymphocytes from a drop of fresh, frozen, or dried blood. According to Epimune, lymphocyte enumeration has a range of applications including diagnosing immunodeficiency, patient monitoring following immunosuppressive therapy, and absolute quantification of circulating B cells for chronic lymphocytic leukemia diagnosis.
The test received CE marking in October.
Under the terms of the deal, Charlotte, North Carolina-based TannerLAC will oversee I.Mune TBNK registration, sales, and marketing activities in Latin American markets. Epimune said it expects the first approvals in this region in the second half of 2021.
Additional terms were not disclosed.