Mikrogen Diagnostik: innovation and competence in serology and molecular diagnostics

Continuation of Lophius’ products after the acquisition by Mikrogen

Mikrogen GmbH has acquired the assets and technologies of Lophius Biosciences GmbH. Combining Mikrogen’s expertise in diagnostics and automation with Lophius’ technology for pathogen-specific immune stimulation will enable novel diagnostic solutions for infectious diseases and complement the Mikrogen portfolio.

In the future, the Lophius-developed in vitro diagnostic kit T-Track® CMV will be marketed by Mikrogen. By measuring CMV-specific cell-mediated immunity, T-Track® CMV adds an additional dimension to anti-CMV treatment decision-making in transplantation. T-Track® CMV complements the currently used CMV viral load tests, empowering clinicians to make personalized treatment decisions.

In addition, Mikrogen will pursue Lophius’ development programs, which include (i) a highly sensitive blood-based next-generation infection detection test that allows to rule-out a tuberculosis (TB) infection early in the diagnostic process, and (ii) a breakthrough solution to reliably differentiate between latent and treatment-requiring active TB infections.

Ordering of T cell-based diagnostic tests for targeted diagnosis and personalized treatment of patients

T-Track® CMV (IVD)

Art no.: 11001003
Order: orders[@]mikrogen.de

The CE-marked in vitro diagnostic test is a highly standardized and ready-to-use IFN-γ ELISpot CMV kit. It enables highly sensitive detection of CMV-specific effector cells and measurement of CMV-specific cell-mediated immunity (CMV-CMI), based on CMV-antigen-induced IFN-γ production, in healthy and immunosuppressed individuals. For fast and easy result evaluation the kit is delivered together with the CE-marked T-Track® CMV Calculator software.

  • Sensitive and standardized ELISpot
  • High clinical sensitivity
  • Assessment of the functionality of a broad network of clinically-relevant CMV-specific effector cells (CD4+ and CD8+ T cells, NK and NKT-like cells)
  • HLA antigen-independent application
  • Low amount of patient blood sample required
  • 24 hour sample storage time
  • Delivered with the T-Track® CMV Calculator software (CE IVD)
  • CE-marked IVD in Europe

T-Track® ELISpot kit human IFN-γ HiSpecificityPRO

Art no.: 12200001 (strips), 12200002 (solid)
Order: orders[@]mikrogen.de

The all-in-one and ready-to-use ELISpot kit was developed to obtain improved results for the assessment of interferon gamma (IFN-γ) release. The ELISpot assay consequently evaluates antigen-specific cellular activity at a single-cell level and therefore enables enumeration of IFN-γ-producing cells. The T-Track® human IFN-γ ELISpot kit HiSpecificityPRO facilitates fast and standardized read-outs, combined with highest specificity and lowest background.

  • All-in-one ELISpot kit
  • For comprehensive analysis of IFN-γ-secreting cells
  • Highest specifictiy
  • Low background
  • Standardized read-out
  • Available in 96-well solid and 12 x 8-well strip format
  • For research use only

T-Track® human IFN-γ HiSpecificityPRO ELISpot plate

Art no.: 12100006 (strips), 12100010 (solid)
Order: orders[@]mikrogen.de

The T-Track® ELISpot human IFN-γ HiSpecificityPRO product line allows standardized read-outs and results characterized by lowest background signals and highest specificity. The precoated T-Track® ELISpot plate human IFN-γ HiSpecificityPRO has been developed for our T-Track® CMV IVD product and fulfills highest quality standards in an elaborated and strictly controlled manufacturing process.

  • Ready-to-use precoated ELISpot plate
  • For comprehensive analysis of IFN-γ-secreting cells
  • Highest specifictiy
  • Low background
  • Standardized read-out
  • Available in 96-well solid and 12 x 8-well strip format

T-activated® proteins

Art no.: 12311001 (IE-1), 12311002 (pp65),
12312001 (BZLF1), 12312002 (EBNA3A)
Order: orders[@]mikrogen.de

  • Modified by Lophius´ T-activation® Technology
  • Are actively processed by APC along the MHC class II and I (cross-presentation) pathways leading to a physiological and comprehensive stimulation
  • Activate simultaneously clinically-relevant populations of effector cells, including CD4+ and CD8+ T cells as well as NK and NKT-like cells
  • Lead to a robust and reliable stimulation of effector cells
  • Applicable for many immunological assays such as ELISpot, FACS and ELISA

Development program breaking the TB cycle

Tuberculosis (TB) remains one of the 10 leading causes of death worldwide with around 1.5 million deaths each year. In addition, one quarter of the world’s population is infected with TB in a latent state, with a substantial probability of 5-15% to develop into active TB disease. This risk is highly increased among immunocompromised individuals, especially in the context of conditions such as immunosuppressive medication during transplantation, treatment of chronic inflammatory diseases like rheumatoid arthritis and Crohn’s disease, or HIV infection. Thus, TB represents an underestimated global health problem and economic burden.

As there is no good vaccine available for TB, the only weapon against this highly-contagious and life-threatening bacterial disease is early diagnosis and therapy. Diagnosing TB, however, remains a major challenge. Supposedly novel diagnostic solutions have not met market needs and hence health systems around the world still largely rely on TB skin tests that are time-consuming, error-prone and ineffective.

Two highly pressing needs in TB screening and diagnosis right now are (1) a diagnostic test that can confirm TB infection with very high accuracy and (2) a diagnostic test that can discriminate or triage patients with active disease from latent TB infections. Shortcomings of the current TB screening process still lead to patients having to go through a set of costly and laborious clinical tests and potentially endure risky procedures or take medication unnecessarily. There is no gold standard to solve either one of the two key problems - accurately detect and triage - consistently.

Mikrogen is addressing this important medical need by developing a blood-based, multi-marker TB screening test with the purpose to deliver a significant improvement in TB infection detection over the existing approaches and to disrupt the field by differentiating between active TB disease and latent TB infection. The test is based on our expertise to accurately mimic and analyze immune reactions in an in vitro diagnostic setting by detecting biomarkers produced by immune cells following pathogen-specific stimulation.

Please contact mikrogen(at)mikrogen.de for further informations.