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Norway's Genetic Analysis Hopes HumGut Database Will Spawn New Diagnostics, Therapies

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NEW YORK — Genetic Analysis, a Norwegian diagnostics company, believes a new database mapping the diversity of the healthy human gut will translate into innovative new tests and drugs and will be of wide benefit to human microbiota-based clinical research.

In particular, the Oslo-based company expects the new resource to strengthen its offerings to pharmaceutical partners, a key customer group. "We have just scratched the surface on something so interesting," said CEO Ronny Hermansen.

With previous work experience at Axis-Shield, now part of Alere, and Nycomed Amersham (later GE Healthcare), Hermansen is well positioned to bridge the gap between the diagnostics industry and pharma. He said that pharma companies are engaged in developing microbiome-altering drugs, an undertaking that intersects with Genetic Analysis' diagnostics work, and have an increased interest in tapping into diagnostic resources.

The new HumGut database will help with this. It is the outcome of a partnership with the Norwegian University of Life Sciences, also based in Oslo, and entails a collection of about 30,000 genomes from bacteria found in the human gut. It also includes a collection of 6,000 metagenomes from healthy subjects, meaning that the database, which is public, can serve Genetic Analysis (and other firms, for that matter) as a normal control during test development.

The creation of the resource was recently detailed in the journal Microbiome. Knut Rudi, an author on the paper and a professor at the Norwegian University of Life Sciences, described it as being "of major significance" as it provides a collection based on occurrence of bacterial genomes in healthy humans worldwide. Among other discoveries, the researchers were able to map about 95 percent of sequencing reads from gut samples to the database, which Rudi said means that "nearly all genetic diversity of human gut bacteria has now been mapped."

"This is a milestone, as we now can shift focus from exploring to developing targeted diagnostics and drugs," said Rudi. "I foresee that the complete mapping of the genetic diversity of gut bacteria will have a similar impact on gut microbiota-based diagnostics and therapeutics as the sequencing of the human genome in the early 2000s had on diagnostics and drugs related to human genetic diseases," he predicted.

Elin Org, an associate professor at the University of Tartu's Institute of Genomics, said that the new HumGut collection "substantially improves the current available databases" of reference human gut metagenomes.

"I believe that this new reference database can provide a significant improvement for further human gut microbiome research, allowing us to more precisely define our gut microbiome community, thus helping to better identify the associations between the microbiome and health and to design further functional studies," said Org, whose research focuses on gut microbiome diversity and who was not involved in the development of HumGut.

Genetic Analysis is maintaining HumGut and will support future upgrades, Hermansen noted. "GA has always been keen on understanding the healthy gut," he said. The company has a predetermined target-based approach, meaning that its tests can be used to surveil samples for the presence of specific, preidentified markers.

Anita Patel Jusnes, the company's chief commercial officer, stressed that HumGut is an open database. "For us, it's important that the whole field of the microbiome can take advantage of this," said Jusnes, who joined Genetic Analysis last year after holding positions at GlaxoSmithKline, Pronova Biopharma, and Novartis.

For her new company, the goal is quite clear, she said. "It's about developing novel panels and interesting signatures, as well as using the database in our research and our pipeline when we look at diseases like diabetes and obesity." Those tools can also be funneled into collaborations with pharmaceutical companies, she added.

"With standardized diagnostic tools, we can map the microbiome and then select the patients that will benefit the most from a treatment," she said. Drugs also have an impact on the microbiome, Jusnes noted, and many have harsh side effects. Patients can develop irritable bowel syndrome from certain therapies, for example, and tests could be used to gauge microbiota response to treatment.

"It would be fantastic to have microbiome testing all the way through your treatment so you know you won't get this side effect," said Jusnes, adding that "our immediate plans are expansion, expansion, expansion."

Genetic Analysis was founded in 2008 and currently employs a team of 22 people. Its core offering is its GA-map Dysbiosis Test, which it provides as a service for use in patient treatment and clinical research. The assay assesses nucleotide differences in the bacterial 16S rRNA gene to identify predetermined targets and runs on the Luminex 200 instrument. Customers use the test to help guide therapy decisions in patients with irritable bowel syndrome, type 2 diabetes, leaky gut syndrome, and other gastrointestinal problems.

The test has had a CE-IVD mark since 2018. Hermansen said that the new In Vitro Diagnostic Regulation coming into force in Europe will focus even more on standardization and clinical documentation. "This has always been a key focus for GA, too," he said. "We believe the new IVDR will give GA a competitive advantage."

In the US, the company's GA-map Dysbiosis Test is currently available for research use only. Hermansen said the company has begun preparing a regulatory path for the test, and its goal is to have the assay cleared by the US Food and Drug Administration.

According to Hermansen, the company's GA-map customer base is linked to the microbiome testing market. "It's mainly IBS holistic medicine specialists," he said. He acknowledged a dive in demand linked to the ongoing COVID-19 pandemic, as patient visits to such specialists have decreased over the past two years. Still, some customer segments, particularly in the US, continue to grow, and volumes are rebounding. "There is a lot of testing going on today, and we are hoping to sign more deals," Hermansen said. In June, the company inked a North American distribution agreement with Eagle Biosciences of Nashua, New Hampshire, for example, to market GA-map.

Hermansen said that Genetic Analysis enjoys a good relationship with Luminex, and that the Austin, Texas-based company, now part of DiaSorin, could serve as a platform provider for future tests.

"We want to fuel labs with standardized microbiome diagnostics," he said. "But we also have a lot of work related to research in academia and pharma. We can help them find signatures or develop diagnostics around any signature they have found."

Indeed, the Norwegian Research Council in June awarded Genetic Analysis and collaborators NOK 16 million ($1.8 million) to develop a new marker for IBD. Under the terms of the grant, the company will develop a new in vitro diagnostic for IBD based on gut microbiota profiles that can predict disease progression and gauge response to treatment. Genetic Analysis is working with partners at Akershus University Hospital, located just outside of Oslo, and at Sahlgrenska University Hospital down the coast in Gothenburg, Sweden, to develop the test.

"We will develop a test to select patients for treatment and to monitor how the microbiome develops in response to treatment, including to levels of dosing," said Jusnes. "We will also compare IBD patients to normal guts" in the HumGut database.

While test development is part of the company's future strategy, Jusnes noted that the firm is engaging all kinds of partners, including probiotics and health and wellness companies, as well as contract research organizations running clinical trials. "These companies are now looking at the microbiome as an additional parameter in clinical trials endpoints," she said.

Hermansen noted, though, that while these markets are attractive for Genetic Analysis, drug development remains a sizable segment. "The one that will fuel our business, and will be mostly linked to the development of new products, is pharma," he said.

One additional goal for the company is going public, and Hermansen said the firm is working towards a listing on the Spotlight stock market in Stockholm in late September. "As a part of the listing, we will raise NOK 60 million to be used for fueling the further growth of the company," he said, adding that the listing will also make GA more visible in the markets.

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