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GenomEra CDX system and PCR tests

A powerful tool to run molecular diagnostics routinely and cost-efficiently without compromising the quality

Finnish Uniogen’s patented GenomEra® technology uses time resolving fluorescence detection with a simple-to-use reagent concept and a small plastic test chip containing all the needed reagents in a dried format. Technology can be used to detect various viral and bacterial pathogens directly from a sample. Both instrument and reagents are CE-IVD marked and they have the Finnish Key Flag Symbol.

Simplicity and speed

Rapid sample pretreatment and fast PCR run time enable the detection of 4 samples in an hour and up to 96 samples in 24 hours per one analyzer. Random access can be obtained by combining multiple GenomEra® CDX instruments into one laptop computer.

Sensitivity and safety

Sensitive end-point detection with time-resolved fluorometry provides good assay sensitivity. Test chips are irreversibely sealed by the analyzer to eliminate the risk of contamination after PCR amplification.

GenomEra® C. difficile Assay Kit

  • Detects toxin B gene from stool samples.

GenomEra® Norovirus Assay Kit

  • Detects Norovirus genotype I and II from stool samples.

GenomEra® MRSA/SA Multi Swab Assay Kit

  • Detects Methicillin resistent Staphylococcus aureus (MRSA) from skin swabs, taken from smultiple body sites.

GenomEra® MRSA/SA AC Assay Kit

  • Detects Methicillin resistent Staphylococcus aureus (MRSA) from bacterial culture, test detects both mecA and mecC genes.

GenomEra® S. pneumoniae Assay Kit

  • Detection of pneumococcal bacteremia from positive blood culture.

GenomEra® GBS Assay Kit

  • Detection of Group B Streptococcus (GBS, Streptococcus agalactiae) directly from a rectal swab or enriched broth.

The GenomEra® HSV-1/2, VZV + EV Assay is an in vitro diagnostic (IVD) multiplex real-time reverse transcriptase polymerase chain reaction (rRT-PCR) assay intended for the qualitative detection and differentiation of viral DNA of herpes simplex viruses 1 and 2 (HSV-1 and HSV-2) and varicella-zoster virus (VZV), and viral RNA of enterovirus (EV). The test is suitable for CSF samples and swab samples with some limitations. Tests are performed on the GenomEra CDX system.

The test utilizes the new column pretreatment that provides a faster hands-on-time, more sensitive results and a possibility to take the sample directly to an inactivating eNAT media (Copan).

Product is available in the following countries:

  • Finland
  • Estonia
  • Latvia
  • Lithuania