Microbiome Applications in IVD

It’s beyond theory.  The microbiome is one of many trends that align well with the IVD market.  It is explored in Kalorama Information’s study of the in vitro diagnostic market, The Worldwide Market for In Vitro Diagnostic Tests along with other trends such as automation and gene editing.   The continuous search of the etiology of diseases as part of the body’s systemic response to change has led to a consideration of the gut microbiome as part of disease processes.  While still in the early phase of development a number of companies have developed assays for the study of the microbiome and there is a proliferation of microbiome related therapeutics.

Bacteria in the gut, mouth and plaque (biofilms) have been implicated in a number of diseases including diabetes, obesity, autoimmune, cancer, diarrhea, and mental disorders.  Thousands of species of microbes—bacteria, viruses, fungi, and protozoa—inhabit every internal and external surface of the human body.  The microbiome’s complicated relationship with its human host is increasingly considered crucial to health.  Imbalances in the microbiome’s diverse microbial communities, which interact constantly with cells in the human body, may contribute to chronic health conditions, including diabetes, asthma and allergies, obesity and the metabolic syndrome, digestive disorders including irritable bowel syndrome (IBS), and autoimmune disorders like multiple sclerosis and rheumatoid arthritis.

The microbiome skincare market is expected to continue to grow by double digits in every country researched (United States, Germany, Korea, Japan, Thailand, and China).  The primary drivers for its growth are the natural wellness trend, the fear of chemicals, increasing influence of environmental stressors, and pharmaceutical company investment.  In fact, recent television ads for skin care soaps in N. America state the product “keeps the skin’s natural microbiome intact.”  There are of course probiotics and books that direct consumers to maintain a healthy gut for overall wellness.

While still in the early phase of development a number of companies have developed assays for the study of the microbiome and there is a proliferation of microbiome related therapeutics.

Intense research into the relationship of a person’s population of normal flora and pathogenic invaders with the etiology and progression of disease states has been developed into microbiome-based molecular tests.  Some IVD companies are already developing a greater appreciation for the microbiome’s contributions to human biochemistry and have launched tests to measure changes in the microbiome to monitor disease progress.  At this time, most testing is available from service providers and for research.  There are however at least two CE Marked test kits available from Genetic Analysis (Oslo, Norway) and Luxia Scientific (France)

Researchers also evaluate specific diseases associated with disturbances in the microbiome, including gastrointestinal diseases such as Crohn’s disease, ulcerative colitis, irritable bowel syndromes, and obesity, as well as urogenital conditions, those that involve the reproductive system, and skin diseases like eczema, psoriasis, acne, obesity, diabetes, autoimmune disorder, acute diarrhea, cancer, mental disorder, and others.

Of interest are the CE Marked tests from Genetic Analysis (Oslo, Norway).  Genetic Analysis was awarded the CE Mark for its Dysbiosis test for microbiome imbalance in irritated bowel syndrome.  Genetic Analysis has developed GA-map technology, the first gene-based routine test for the mapping and aide in diagnosis of diseases associated with dysbiosis and imbalances in the bacteria in the digestive system.  Genetic Analysis was established in 2008 and is based on research done by Professor Knut Rudi at Norwegian University of Life Sciences.

In 2018, Luxia Scientific (Paris, France) was awarded the CE Mark for its 1test1 that analyzes the bacterial content of the gut microbiome.  Leveraging 16S rRNA sequencing, it provides information about bacterial diversity and the relative abundance of many bacterial groups that provide beneficial health benefits, (according to Luxia).   In March 2018, Luxia announced an exclusive distribution agreement with Life Genomics (Sweden) whereby Life Genomics will exclusively distribute Luxia’s 1test1 test in Sweden, Denmark, Finland, Iceland, and Norway.

Other IVD industry initiatives include:  OraSure Technologies (Bethlehem, PA) is best known for its point-of-care diagnostic tests for infectious diseases and molecular sample collection devices.  In January 2019, OraSure acquired CoreBiome (St. Paul, MN) an early-stage microbiome services provider for customers in the pharmaceutical, agricultural, and research communities.  The company’s slogan is “Powering microbiome science with big data”.  CoreBiome’s technology provides information-rich characterization of microbial diversity and function, paired with machine learning and expert analytics.  CoreBiome’s BoosterShot platform allows researchers to efficiently run high-resolution DNA sequencing on thousands of microbiome samples.  OraSure indicated that CoreBiome’s microbial genomics technology will complement the company’s DNA Genotek’s molecular sampling business.

Bio-Rad Laboratories entered into a collaboration with Genetic Analysis AS (Oslo, Norway) and Bioaster, a French microbiology research institute, to study gut microbiome alterations in metabolic disorders.  The project will look for microbiota signatures of dysbiosis in metabolic disorders like diabetes and obesity in order to pursue diagnostics development.  It will use Bioaster’s deep and 16S-targeted sequencing technologies and advanced pipelines of data analysis for highlighting new gut microbiome biomarkers, according to a statement.

Bio-Rad acquired the distribution rights for the CE Marked GA-Map test made by Genetic Analysis (Oslo, Norway).  The assay tests for gut microbiota and detects bacterial imbalances to diagnose and manage conditions such as inflammatory bowel disease and irritable bowel syndrome to detect imbalances in the gut microbiome.  GA-map uses 16S rRNA amplification and a number of proprietary analysis technologies.

Thermo Fisher launched the Applied Biosystems Axiom Microbiome Array for simultaneous detection of archaea, bacteria, fungi, protozoa and viruses in human and non-human samples. Developed in collaboration with the Lawrence Livermore National Laboratory (LLNL), the array is designed to increase the understanding of microorganisms, while accelerating the translation of these insights into human health and agricultural applications.

According to Thermo Fisher, a major advantage of the array, which incorporates sequences for over 12,595 species in the National Center for Biotechnology Information (NCBI) archive, is the simultaneous detection of protozoa and viruses and ease of analysis, a capability that is not available with 16S or other platforms.  Most recently, the Axiom Microbiome Array won the R&D 100 Award, which honors great R&D pioneers and their revolutionary ideas in science and technology.  Awarded by R&D magazine, and considered the “Oscars of Innovation”, the R&D 100 Awards recognize and celebrate the top 100 technology products of the year.