CE mark

The immunoassay can be used to monitor cancer cell remnants in a patient's body and help determine which patients need less invasive treatment.

The company said the test can be used to evaluate effective antibody levels after SARS-CoV-2 infection or vaccination, as well as to assess adaptive immunity.

The firm's assay leverages reverse transcriptase quantitative PCR to amplify two separate regions of the HIV-1 genome to monitor HIV-infected patients.

The test leverages ELISA technology and uses non-pathogenic viral proteins, enabling its use in common lab settings either manually or automatically.

The panel, which includes three immunoassays, identifies the infection stage of the Epstein-Barr virus from a blood sample.

The automated sample-to-answer platform allows for a variety of assay types to be run simultaneously, such as molecular, immunochemistry, and cytometry tests.

The company said the test detects four SARS-CoV-2 variants and two biologically significant mutations, all of which are now prevalent globally.

The test is fully automated from sample to result interpretation and requires one whole-blood sample tube with no manual sample preparation necessary.

The firm said it will begin running its urine-based test immediately in its clinical laboratory in Munich and make it available throughout Europe.