Luminex Licensed Technologies Partner Spotlight: Genetic Analysis
Mapping gut microbiota to aid in dysbiosis diagnosis
Luminex Licensed Technologies Partners represent a diversity of market segments, company sizes, and geographies. The versatility of xMAP® Technology has supported the launch of thousands of assays formatted into commercially available kits and testing services.
Detlef Janke, Sales Director at Genetic Analysis, shares how their xMAP-based dysbiosis assay maps gut microbiota and provides insights into the causative role of bacterial composition profiles in bowel disease.
Why is Genetic Analysis interested in the microbiome?
The gut microbiome is increasingly being considered our second genome with huge implications in human health and disease. At Genetic Analysis, we see an urgent need in the diagnostic field to standardize and document microbiota tests to offer a reproducible deletedanalysis.
Inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) are relatively common conditions that combined afflict approximately 15% of the population. IBD is chronic inflammation of the digestive tract, which includes ulcerative colitis and Crohn’s disease, while IBS affects the function of the intestines without the associated inflammatory damage. While these conditions are well characterized, the cause remains unknown. Our test profiles an individual’s microbiota and compares the profile to those of healthy persons.
Can you tell us about the Genetic Analysis product?
Genetic Analysis developed the GA-map™ Dysbiosis Test, which profiles 54 bacteria groups that cover 300 clinically-relevant bacterial strains and provides gastroenterologists with an easy to interpret result.
Currently, clinicians can send samples to the Genetic Analysis service lab facility located in Oslo, Norway for processing and analysis. In the future, laboratories will be able to perform the assay using kits purchased from Genetic Analysis or its distributors, including Bio-Rad Laboratories, Inc., for use on their own xMAP instruments.
What are the benefits of the xMAP-based platform?
We developed a unique probe design tool and robust workflows to generate and validate probe sets based on the 16S rRNA gene. In contrast to sequencing, each target is confirmed by performing Single Nucleotide Probe Extension (SNuPE), allowing the GA-map Dysbiosis Test to confidently confirm the probe target DNA. We perform the target analysis using our extensive bacterial DNA biobank to verify that the bacterial probe actually hybridizes to the bacterial DNA it is designed against — a single target for a species or multiple targets for a bacterial family.
While sequencing approaches are the current diagnostic standard, the method lacks standardized targets and produces variable readouts from lab to lab. In addition, significant quantities of raw data are generated which require analysis by biostatisticians for clinical interpretation. In contrast, GA-map is a standardized test that ensures the results are comparable across patients, clinics, and research studies; the data are provided on two scales that clinicians can decipher themselves:
- Relative abundance scale from -3 to +3, as compared to the reference population of normal healthy Europeans
- Dysbiosis indicator from 1 to 5, where 1 and 2 are normal and 3 to 5 states of dysbiosis
Why did Genetic Analysis adopt xMAP® Technology?
Luminex’s xMAP Technology was very attractive to us because of the reputation for reliability and the broad placement of instruments in the field. In addition, the technology allows us to measure multiple targets in one well, which is a core feature of this type of multiplex assay that leads to a fast and cost efficient analysis.
What’s next for Genetic Analysis?
We are currently working to support further IBS/IBD studies, as we currently have only a few peer reviewed publications describing the development of the GA-map assay, the impact of a low sugar diet on bacterial populations, and the role of autoimmunity in dysbiosis. In the future, we intend to investigate the association between microbiota imbalances and other disease states such as obesity, diabetes, and neurologic disorders.
Are you interested in developing, manufacturing, and commercializing a multiplexed assay on a platform that is efficient, flexible, and widely-adopted? Contact Luminex Business Development to learn more.
Luminex and xMAP are trademarks of Luminex Corporation. GA-map is a trademark of Genetic Analysis AS.