Laboratories

Power your lab to become a market leader in the microbiome testing segment

GA-map® Dysbiosis Test provides the foundation to bring microbiome testing from research to routine diagnostics with a robust and documented tool for microbiome profiling.

Let us join forces today to build a successful business in this fast-growing microbiome market.

Easy to integrate

High throughput

Short turnaround

CE-IVD marked

Innovative technology

GA-map® Dysbiosis Test is an innovative probe-based technology that represents the next step in gut microbiota diagnostics.

GA-map® Dysbiosis Test is CE-IVD marked, standardized for clinical routine testing and provides easy to interpret results.

Validated and CE-IVD marked

GA-map® Dysbiosis Test is designed to diagnose and characterize dysbiosis from a fecal sample. It has been validated using independent cohorts of clinically validated healthy volunteers, IBS and IBD patients.

The technology utilizes amplification of the 16S rRNA gene, present in all bacteria, for simultaneous detection of 48 clinically relevant bacteria markers.

Benefits of the GA-map® technology

Speed and throughput

Results in 1-2 days for hundreds of samples

Cost efficiency

Low cost per sample

Specificity

Species level resolution

Reproducibility

Standardised, highly accurate and reproducible results

Pre-determined approach

A panel targeting only the relevant bacteria

Multiplexity

Detects up to 80 targets per well

qPCR
16s rRNA Sequencing
Shotgun metagenomics
GA-map®

GA-Map® Dysbiosis Test

Reference values

Relative abundance compared to healthy normal

No data processing steps

Patented algorithm providing ready-to-use results

Dysbiosis Index

Validated dysbiosis indicator

CE-IVD marked

Meets high safety, health, and environmental requirements

CE-IVD marked

Reproducible

Clinically validated

Pre-determined targeting

What is GA-map® technology?

The unique GA-map® platform presents a different approach in microbiota analysis from sequencing and the current clinical diagnostic methods. GA-map® is a pre-determined multiplex assay specialized for simultaneous analysis of a large number of bacteria in one reaction. Our technology utilizes occurence of sequence variations on the bacterial 16S rRNA gene in the design of highly specific DNA probes, which are able to differentiate between bacteria groups based on their gene sequence.

As opposed to sequencing, GA-map® uses almost the whole length of the 16S gene (variable regions V3-V9) to enable better recognition of bacteria on low taxonomic levels. The panel consists of 48 bacterial markers, targeting over 300 bacteria on different taxonomic levels. Depending on the composition of bacteria present in each sample, the probes in the GA-map® panel will bind to their respective target DNA and produce a signal.

The markers selected for the panel have the ability to distinguish between a healthy balanced microbiota and a state of dysbiosis, commonly observed in gastrointestinal disorders. The assay incorporates MagPlex® microspheres for solid phase hybridization and easy readout on Luminex®200™ or MAGPIX® instruments. Find out more about the Luminex® instruments here:

Visit the Luminex website for information on the instruments

The test results are generated by utilizing the clinically validated cutting-edge GA-map® software algorithm, which enables immediate results without the need for further bioinformatic work. The overall turnaround time for the GA-map® assay in the lab is 1-2 days.

Procedure of the GA-map® technology

Sample Collection

STEP 1

gDNA extraction

STEP 2

Amplification of 16s rRNA gene

STEP 3

Quantification of
 PCR product

STEP 4

Clean-up of PCR
 product

STEP 5

End-labeling of probe set

STEP 6

Hybridization and signal detection

Data QC and result generation

Easy-to-read test results

With the GA-map® technology, the need for comprehensive result calculations in microbiota testing is obsolete. The raw data are processed through a unique algorithm and compared to a healthy reference population to obtain clinically meaningful results.

The results are presented in an easy to read report form based on information from 48 preselected bacteria markers, included in the panel because of their discriminatory power in distinction between normal and dysbiotic gut.

Using the cutting edge GA-map® technology, one reaction gives answers for 48 bacteria markers which represent approximately 300 bacterial species detected at different taxonomic levels.

Download a sample report for free below.

Dysbiosis index (DI), measured on a 5-point scale from 1 (normobiosis) to 5 (severe dysbiosis), where DI values>2 indicate the presence of dysbiosis. Dysbiosis index shows how much the bacterial profile of a sample deviates from a normal, healthy reference population.

How to get your lab started

STEP 1

Check if your lab is equipped with all necessary instruments according to our P.I.G.

STEP 2

Our tech-transfer team will help you install the platform and train your staff.

STEP 3

You’re ready to run GA-map®!

CUSTOMER SERVICE

You can always contact our support team. We will be your partner every step of the way.

Publications

The GA-map® technology holds the potential for development of In-Vitro Diagnostic (IVD) tests for all diseases and conditions where the microbiota is involved. An increasing number of researchers have discovered the efficiency and simplicity of the GA-map® Dysbiosis Test in gut microbiota analysis.

Merging the rapidness, preciseness, and robustness of RT-PCR approaches with the comprehensiveness of next-generation sequencing, the GA-map® technology drastically reduces the time from analysis to publication. The GA-map® technology has until now been applied in clinical research in the fields of gastroenterology (IBS and IBD) and metabolic disorders (Diabetes and Obesity).

GA-map® global network

Curious? Get in touch to know more about our GA-map® Flagship Labs worldwide

We used GA-map® in our clinical research within IBS. We have great experience with GA-map® as a tool to select, monitor and follow-up patients.

Professor Magdy El-Salhy

Stord Hospital, Helse Bergen and the University of Bergen, Norway

Professor Magdy El-Salhy

There is still so much to learn about the microbiome, we are only just beginning to discover its importance, and the GA-map Test will help us do just that.

Emeritus Professor Peter Malfertheiner

Senior Professor at the Ludwig Maximillian University, University Clinic in Munich, Germany

Emeritus Professor Peter Malfertheiner

Industry partners

Academic network

Frequently asked questions

Accumulating evidence show a profound association between dysbiosis and a wide range of health disorders, including irritable bowel syndrome (IBS), inflammatory bowel diseases (IBD), colon cancer, non-alcoholic fatty liver disease (NAFLD), major depression disorder, ASD, Parkinson’s disease, obesity, etc.

The gut microbiota is the most abundant microbiota in the human body. We have a set of core functional bacteria that are involved in vital function such as areas of gut-barrier defense, nutrition and behavior. These core functional bacteria are common to all healthy humans. However, each individuals gut microbiota composition is mostly unique.

Gut bacteria composition can be influenced by various factors such as parental microbiota, genetics, age, diet, environment and medication, while it has a multitude of functions in the.

Under normal conditions, the various bacteria species present in the human gut exist in a balance.

A loss of this balance, resulting in alterations to the gut microbiota composition (loss of species diversity or overgrowth of single bacteria species) is called dysbiosis.

Dysbiosis can be induced by various external factors, some of these are: low-fiber diet, antibiotic intake or excessive alcohol consumption and is also associated with a number of diseases.

Gut microbiota dysbiosis is often associated with overgrowth of opportunistic pathogens and depletion of commensal bacteria, resulting in disturbances of the microbiota’s digestive and anti-inflammatory functions.

Functional impairments can lead to inflammation of the intestinal mucosa, which in turn can take part in the development of chronic diseases, such as IBS, IBD or cancer.

Moreover, dysbiosis and inflammation have been observed in numerous other conditions, such as diabetes, chronic fatigue, allergies, anxiety, depression and Parkinson’s disease.

The GA-map® technology utilizes instruments commonly used in clinical laboratories. Follow our Pre Installation Guide to check if your lab is equipped with the right instruments.

Our technology transfer team will assist you through the installation process and perform comprehensive training for your staff.

We will make sure you have everything you need to start running the GA- map® assay. Close follow-ups are always included in our technology transfer service.

Contact us for more information about technology transfer.

GA-map® utilizes well-established molecular lab techniques and instruments commonly used in clinical laboratories. DNA extracted from the samples does not require extensive processing or library preparation, allowing for complete analysis from sample to result in 1-2 days.

The GA-map® software performs quality control and generates sample reports with no need for additional data processing steps. The GA-map® Dysbiosis Test is complemented with an instruction video and a detailed user manual.

The GA-map® assay uses a selection of 48 probes targeting >300 bacteria on different taxonomic levels. Samples from a normobiotic reference population were used to develop a dysbiosis model with a bacterial profile and dysbiosis index score output.

The model algorithmically assesses fecal bacterial abundance and profiles, and potential clinically relevant deviation in the microbiome from normobiosis. This model was tested on samples from healthy volunteers, IBS and IBD patients to determine the ability to detect dysbiosis.

The GA-map® assay is documented and standardized for clinical routine testing and provides standardized, easy to interpret results.

The GA-map® Dysbiosis Test is designed to diagnose and characterize dysbiosis from a fecal sample. The test has been validated using independent cohorts of healthy volunteers, IBS and IBD patients.

The technology utilizes amplification of the 16S rRNA gene, present in all bacteria, for simultaneous detection of 48 clinically relevant bacteria markers.

GA-map® was developed using cohorts of both healthy individuals as well as IBS and IBD patients. A healthy reference population was used to establish relative abundance of bacteria species and to assess deviations from the normobiotic composition.

The GA-map® Dysbiosis Test is CE marked and IVD-R compliant. Standardization of the test ensures repeatable and accurate results.

The GA-map® reagent kits are produced following the ISO 13485 standard for medical devices.

The GA-map® Dysbiosis Test reagent kit contains all the reagents required for the analysis. Additional kits are required for gDNA isolation and quantification.

The unique, patented algorithm in the GA-map® software calculates the dysbiosis index, several functional bacteria profiles and the relative abundance of 48 clinically relevant bacteria for each sample.

The results are presented in an easy-to-read report form generated by the GA-map® software. Alternatively, the results can be exported via a LIMS software and used to generate customized report forms.

See an example of a report form here: Link to report form pdf

GA-map® collection kit includes everything you need to safely collect and ship a sample. The small, but representative, sample of fecal material is diluted in a tube that contains stabilizing buffer (eNATTM™).

The buffer inhibits bacterial growth as well as stabilizing DNA and RNA in the sample; preserving the sample for transport and storage prior to analysis.

Instructions and instruction video (QR) are printed on the inside of the box. Watch the animated video that takes you through the sample collection procedure.

Get started with GA-map®

Curious to learn more?