Companion Diagnostics

Routine molecular diagnostic laboratories can benefit from using GA’s products by choosing one of two options: 

  1. Use of GA map® reagent kit: The routine diagnostic laboratory can implement the GA-map® Technology platform and established the GA-map® Test. Fecal samples are locally collected and analyzed by the laboratory. GA will continuously provide CE-marked and validated reagents kit.
  • Use of GA service laboratory: Fecal samples are locally collected, assembled by the routine diagnostic laboratory, and regularly send batchwise for analysis and reporting to Genetic Analysis service laboratory, Oslo Norway. Encrypted reports are sent back to the routine diagnostic laboratory. 

The two products GA provides are the GA-map® Dysbiosis Test and the GA-map®COVID-19 Fecal Test. The two tests can be set up in any PCR laboratory and GA provides reagent kit for own use or we do the analysis and reporting of the result at our service laboratory. With more than 10 years of experience in gut microbiota analysis, we provide you with a reproducible, standardized and well-documented, CE-marked service to support your drug development projects, to assess gastrointestinal treatment effect on gut microbiota and measurement of gut microbiota variation in clinical settings.  

The GA-map® Dysbiosis Test

Genetic Analysis has developed a CE-marked probe-based gut microbiota test on the Luminex® 200 instrument. The technology takes advantage of nucleotide differences in the bacterial 16S rRNA gene to identify predetermined targets. The GA-map® Dysbiosis Test Lx is fully validated according to the IVD directive 98/79/EC and is the first CE-marked IVD test on the market providing microbiota profiles and dysbiosis status in IBS and IBD patients. The method can be set up in any PCR laboratory or samples can be shipped to our service laboratory in Oslo, Norway.

The GA-map® Dysbiosis Test reagent kit is an CE-IVD documented test designed for use in molecular labs. The reagent kit is produced in our ISO 13485 certified facilities in Oslo, Norway. Included in the product is a software that performs QC on the run file, calculates the dysbiosis index (DI) score and Abundance table and converts each sample result into an easy-to-understand result report. At the core of the sw is an algorithm that absorbs GA’s large normal healthy reference and every sample analyzed is compared to this reference. The Instruction for Use describes all assay steps in detail and is documented to yield highly reproducible and robust results.

Key Advantages with the GA-map® Dysbiosis Test:

  • The technology for the test can be set up at any PCR laboratory or samples can be sent to the GA service laboratory
  • An easy and useful tool in patient treatments of IBS, IBD, diabetes type 2, lifestyle diseases, leaky-gut syndrome and other gut disorders
  • the GA-map® Dysbiosis test is reproduceable, standardized and fast
  • An increasing number of researchers have discovered the efficiency and simplicity using the GA-map® Dysbiosis Test in gut microbiota analysis
    • Link to publication list
  • Customized dysbiosis index after your needs
  • Lab analysis time and report completion within 2 days

The GA-map® COVID-19 Fecal Test

the GA-map® COVID-19 Fecal Test is a Qualitative Real Time standardized PCR test for the detection of the 2019 novel coronavirus (SARS-CoV-2) RNA in stool samples and is validated and CE -marked. The test is a valuable tool in patient management and in surveillance of healthcare workers with frontline exposure. 

The GA-map® Covid fecal test reagent kit is an CE-IVD documented test designed for use in molecular labs. The reagent kit is produced in our ISO 13485 certified facilities in Oslo, Norway. The reagent kit has been documented to reliably detect SARS-CoV-2 in fecal samples. The assay is a qPCR assay designed in compliance with US-CDC guidelines and recommendations for detection of SARS-CoV-2.

Key advantages with the GA-map® COVID-19 Fecal Test:

  • The technology for the test can be set up at any PCR laboratory or samples can be sent to the GA service laboratory
  • Fast and accurate detection of SARS-CoV-2 RNA presence in fecal sampling using robust RT-PCR technology
  • Prolonged detection period of positive samples compared to nasopharyngeal specimens  
  • Instrumental part of the multiple specimens testing strategies: help to reduce false negative results

Service laboratory

Our service laboratory in Oslo, Norway can analyze the cohorts of your clinical research on gut microbiota and reporting of the results.  

Reference population comparison

The bacteria abundance from your test is compared to our normal reference population. The GA-map® analyzer software algorithm calculates the degree of dysbiosis in the sample.


The performance of the GA-map® technology is well documented through extensive verification and validation. The standardization and documentation of the GA-map® Test ensures highly reproducible results.

ISO certified and CE-marked

Genetic Analysis AS is an ISO 13485:2016 certified company. The GA-map® Dysbiosis Test Lx is CE-marked in Europe and available for research in the US.

Clinical validated

The GA-map® Dysbiosis Test is clinical validated through cohorts of subjects with normal gut microbiota and patients with IBS and IBD. Further, the test has been used in a number of clinical studies on numerus patient cohorts published in peer reviewed journals. (Link to publications). Hence, the GA-mapâ Dysbiosis Test is standardized and documented for clinical use.

The GA-map®COVID-19 Fecal Test is clinical validated and CE-marked 

Interpretation of the result from the GA-mapâ Dysbiosis Test

All pre-processing of the data is done by the GA-map® Dysbiosis Test analyze software. The test reports are automatically generated on the DI and the bacteria abundance. The DI can be customized to your needs. Based on a deviation from a normal reference population, a measure of bacteria abundances and deviations to the references are calculated. The results are presented in an easy to interpret report form, containing the 48 preselected bacteria markers.