Norwegian molecular diagnostics firm Genetic Analysis announced two new developments last week. The first was the appointment of Kari Stenerson, a former Axis-Shield marketing director, as its new CEO. The second was its plan to have an array-based in vitro diagnostic for diseases related to gut imbalances on the European clinical market by the end of the third quarter.
Stenersen told BioArray News this week that Genetic Analysis hopes to be able to sell its GA-map IBS test with a CE-IVD mark sometime this summer. The test is currently being used in several clinical trials that will provide the necessary data to allow Genetic Analysis to market the diagnostic as a medical device, she said.
GA-map IBS uses gut microbiota profiles to identify patients with irritable bowel syndrome, or IBS, by distinguishing them from patients with other gastrointestinal disorders. According to Stenersen, its target customer group is gastrointestinologists, but it is molecular laboratories that will run the test.
Stenersen added that the firm plans to seek US Food and Drug Administration clearance for the assay, though she did not provide a timeline for when such clearance could be achieved. She noted that the FDA submission data could be used to fulfill regulatory requirements in other countries, such as China.
According to Stenersen, Genetic Analysis' main focus has always been gastrointestinal disorders, such as IBS and inflammatory bowel disease. She said the five-year-old, Oslo-based company decided to develop tests for such conditions because there is a "clear unmet medical need" for better tools for diagnosing and personalization of treatment, as well as monitoring the effect of treatment.
"Between 10 and 20 percent of the population suffers from IBS or IBD," Stenerson said. "Even though it is now well established that patients with these diseases have an altered gut microbiota, no diagnostic tool is available in the marketplace to profile these changes," she said. Should the firm's GA-map IBS test achieve a CE-IVD marking, Sternersen claimed GA would be the "first company to offer such a test to market."
It is not clear if similar array-based IBS tests are in development. Progenika, a Derio, Spain-based company, does offer an array for irritable bowel disorder research called the IBDChip (BAN 11/3/2009). Emails to Progenika seeking an update on the status of the IBDChip were not returned.
A bit further removed from Genetic Analysis' target market are gastrointestinal panels sold by a number of firms that are based on microarray and multiplexing platforms. Last month, Luminex achieved US Food and Drug Administration clearance for its xTAG Gastrointestinal Pathogen Panel for marketing in the US (BAN 1/15/2003). The Austin, Texas-based company claims that xTAG GPP can detect 15 total gastrointestinal pathogens in a single, five-hour assay. The xTAG GPP is not intended for distinguishing IBS from other gastrointestinal diseases though.
GA-map and NGS
Genetic Analysis' platform, GA-map, is based on technology developed at the University of Oslo and the Norwegian Food Institute (BAN 12/1/2009). Its 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.
To accomplish this, 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. As part of the array, a two-step single nucleotide-extension reaction is 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 is ready for analysis.
Stenersen said that GA-map is "ideal for diagnostic use." Because the bacteria of interest are predefined, it is possible to compare various samples, either from the same patient or from different samples, in a reproducible manner, she said.
Next-generation sequencing has also been used to profile gut microbiota in suspected IBS cases. In a recent PLoS One paper, scientists at Wright State University in Dayton, Ohio, used the technology to profile pediatric patients with suspected IBS. In addition, a team from the University of North Carolina at Chapel Hill published a study last year where they used sequencing to compare the composition and diversity of intestinal microbiota from different IBS patients.
Still, it is unclear if a sequencing-based IVD for IBS is in development. Stenersen added that she does not see next-generation sequencing-based approaches for gut microbiota profiling as competitive with the GA-map technology, stating that Genetic Analysis' "high-throughput" platform can process more than 90 samples in two days from the acquisition of fecal sample materials to the final report, while NGS is "more used for description and discovery purposes."
Genetic Analysis offers its array-based assays as a service through its laboratory at Oslo's Bioincubator science park, which is near the Norwegian University of Life Sciences. The company claims it can analyze between 100 and 200 samples in less than 48 hours. Stenersen said its ambition, though, is to become a kit provider, so that accredited service labs can carry out its tests.
In addition to GA-map IBS, the company has two other assays listed on its website: GA-map MFA for dysbiosis testing, and GA-map CORE for general profiling of gut microbiota. Both assays are listed as being for research use only. Stenersen said that GA-map CORE became available last year. She did not comment on the status of GA-map MFA.
Management Changes
While Stenersen's appointment as CEO of Genetic Analysis is new, she has been involved with the firm since 2011, when she was elected to chair its board. Stenersen was senior vice president of marketing and sales for Axis-Shield, a Scottish-Norwegian IVD firm, until it was acquired by Alere Pharmaceuticals in 2011. Prior to her 12-year tenure at Axis-Shield, she was a marketing director for various pharmaceutical companies in Norway.
Rune Sørum, Genetic Analysis' new chairman of the board, said in a statement that Stenersen's appointment was an "important step to ensure the right expertise and focus with the company to reach our ambitious goals for 2013."
Sørum has been a board member of Genetic Analysis and is a partner in Norsk Innovasjonskapital AS, the firm's main investor.
He credited outgoing CEO Morten Isaksen with overseeing the development of GA-map to the stage where Stenersen can "drive forward its commercialization, drawing on her extensive experience in building up other successful diagnostic companies." Isaksen will remain at Genetic Analysis as chief scientific officer and R&D director, the company said.