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Genetic Analysis Forecasts 2015 US Launch for IBS Test as Commercialization Begins in Europe


By the end of 2015, Norwegian molecular diagnostics firm Genetic Analysis hopes to have a microarray-based test for diagnosing dysbiosis in irritable bowel syndrome patients cleared for clinical use in both Europe and the US.

CEO Kari Stenersen told BioArray News this week that the Oslo-based firm anticipates CE-IVD marking the test next month, with a planned submission to the US Food and Drug Administration anticipated in the first quarter of 2015, followed by clearance at the end of that year.

Genetic Analysis recently raised $2 million to "finalize technical and clinical documentation" for the CE-IVD mark, Stenersen said. But the company will need more funding to "cover FDA documentation and broad commercialization" in Europe and the US, she said.

Though the company did not identify the investors that took part in the $2 million round, Rune Sørum, a partner in the investment firm Norsk Innovasjonskapital and chairman of Genetic Analysis' board, said in a statement that there was "strong interest" in the recent round of funding, and "once we have achieved our initial objectives, we will be looking to commence a larger round in early 2014."

Genetic Analysis' GA-map assay, which targets dysbiosis — an imbalance of gut microbacteria that can lead to the development of irritable bowel disease, inflammation, and autoimmune diseases — was developed at the University of Oslo and Norwegian Food Institute. The assay consists of probes and primer sets for between 30 and 200 different bacterial species present in the gastrointestinal tract that can be detected on a microarray platform.

Specifically, total bacterial DNA is extracted from a stool sample and disrupted mechanically with magnetic beads, after which the 16S rRNA gene is amplified. The company then uses its GA-map Probe Tool to identify probes that can be used for a specific phyla, genera, family, or individual strain. Using an array, a two-step single nucleotide-extension reaction is then carried out that fluorescently labels the DNA. If bacteria represented by the probes are present in the stool sample, the probes will bind and be labeled. After hybridization, the array is scanned using conventional equipment, and a microbial profile is generated and ready for analysis. According to the firm, the resulting information can be used to distinguish patients with IBS or IBD from those with other gastrointestinal disorders.

According to Stenersen, there is a need for such an assay as "there has not been any objective test to diagnosis imbalance in microbiota" even though the condition has attracted "a lot of attention from specialists." She referred to a 2004 Case Western Reserve University study that estimated direct and indirect costs related to IBS to be about $30 billion. A 2006 study carried out by Universitaire de Québec Hôpital St-Sacrement in Quebec City, Canada, found that patients diagnosed with IBS had a 31.4 percent decline in work productivity, Stenerson noted.

Such "high economic costs," coupled with an estimated affected population of between 10 and 15 percent in the US and Europe, have led Genetic Analysis to "expect large demand" for its test. Ahead of its anticipated November CE-IVD marking, the company will promote the assay later this month at the United European Gastroenterology Week meeting in Berlin, as well as in November at the
Scandinavian Association for Neurogastroenterology and Motility conference in Copenhagen.

Genetic Analysis was founded in 2008 and has other panels on the market or in development. In addition to its IBS-Dysbiosis Test, the firm sells an assay for research use called GA-map CORE that can be used to profile an individual's gut microbiota in general.

Stenerson said that the company has ongoing programs related to dysbiosis in obesity patients and to IBD in patients who suffer from type 2 diabetes. "The GA-map technology can be used in all diseases where mapping of imbalance in microbiota is of interest," she said. Genetic Analysis claims on its website that it also maintains a services laboratory that can turn around several hundred samples in a number of days.

Stenerson joined Genetic Analysis earlier this year (BAN 2/26/2013). She previously was a marketing director at Axis-Shield, a Scottish-Norwegian in vitro diagnostics firm, where she was responsible for its Afinion point-of-care system. She's also held various positions in pharmaceutical companies.

Stenersen plans to take Genetic Analysis' menu of microarray-based tests into other markets.

"In addition to Europe and the US, which are our first priority, we are aiming to go worldwide, particularly in Asia," she said.

While it advances its diagnostics agenda, the company announced separately last month that it is participating in IBD Character, an EU Seventh Framework Program-funded project to collect samples from patients with early stage IBD. As part of the project, Genetic Analysis will analyze the patients' gut microbial content, while other participants will study DNA methylation, protein markers, and genotypic information, in order to create a "molecular snapshot of IBD in its early manifestation." The profiling will then be used to develop a list of biomarkers associated with the onset of the disease.

The gut, and nothing but ...

At least one other company has brought an array-based test for IBS to market. Derio, Spain-based Progenika developed and launched a product for IBD research called the IBDChip several years ago, but the company no longer advertises the array as a product on its website (BAN 1/3/2009).

CEO Antonio Martinez earlier this year said that the company was more focused on its blood-typing products, such as its BloodChip, and its Luminex-based IDCore assays (BAN 3/12/2013).

In addition, last year, researchers from the University of Bologna in Italy described an array-based tool for profiling gut microbiota called the High Taxonomic Fingerprint Microbiota Array. However, that chip has not been commercialized.

Some other companies have been developing tests for gastrointestinal diseases.

Luminex earlier this year launched and began marketing its xTAG Gastrointestinal Pathogen Panel in the US. The FDA-cleared xTAG GPP can detect up to 15 gastrointestinal pathogens in a single, five-hour assay. Unlike Genetic Analysis' test though, the xTAG GPP is not intended for distinguishing IBS from other gastrointestinal diseases.