The firm recently announced that it is developing a new range of clinical flow systems that it expects to launch over the next five years.
The test, the agency said, is the first authorized by it for use with flow cytometry to detect leukemias and lymphomas.
The firm's first assay will be for Hodgkin lymphoma, but a liquid biopsy test for prostate cancer has also shown strong predictive power in initial validation data.
The companies will initially focus on developing a companion diagnostic for Merck's investigational B cell lymphoma drug M7583.
The company said its HTG EdgeSeq system and EdgeSeq Diffuse Large B-Cell Lymphoma Cell of Origin Assay may now be distributed in the EU.