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Rebiotix to Use Genetic Analysis' Microarray Tools in Biotherapeutics Development Efforts

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NEW YORK (GenomeWeb) – Rebiotix, a Rosewood, Minn.-based biotherapuetics developer, has adopted Genetic Analysis' microarray-based GA-map dysbiosis test for use in its R&D programs, the companies announced this week.

Oslo, Norway-based Genetic Analysis achieved a CE-IVD mark for the assay earlier this year. The test consists of probes and primer sets for between 30 and 200 different bacterial species present in the gastrointestinal tract that can be detected from fecal samples on a microarray platform. Based on the assay's results, European clinicians can distinguish patients with irritable bowel syndrome from those with other gastrointestinal disorders, the company claims.

Rebiotix CEO Lee Jones told GenomeWeb in an email that his company decided to partner with Genetic Analysis not only for its "innovative" technology, but because of its recent experience in obtaining a CE-IVD mark for GA-map.

"We are looking to expand into Europe and are interested in working with companies that have knowledge and success with European regulators," Jones said. 

"In regards to how we plan on using their technology, we are investigating new therapeutic indications, and it provides a standardized way to compare a normal healthy human to a person who has a particular disease state," Jones said of the test. "It may help us identify characteristics within the patients that may lead to more targeted therapies."

Rebiotix is developing different treatments for gastrointestinal diseases, with a focus on using human gut flora to reverse pathogenic processes through the transplantation of live microorganisms. 

The privately held, three-year-old company's lead product, RBX2660, is targeted at recurrent Clostridium difficile infection. Last year, the US Food and Drug Administration gave Rebiotix the go-ahead to embark on a Phase II clinical study of RBX2660, which is currently underway. Should the FDA eventually give the green light to RBX2660, it would be the first drug based on the human microbiome to achieve regulatory clearance.

For Rebiotix, the new deal with Genetic Analysis makes sense for a "variety of reasons," Jones noted, not only by giving the biotherapeutics developer a new tool to use in its R&D programs, but additional insight into entering the European clinical market. For Genetic Analysis, though, the agreement with Rebiotix is its first US pharma collaboration, and represents a "breakthrough for Genetic Analysis and recognition of the quality of our GA-map technology," CEO Kari Stenersen told GenomeWeb.

"We aim to build on this and see the US becoming a very important market for our test," she added.

According to Stenersen such deals are part of the company's strategy. In addition to offering its arrays for routine clinical testing and research, agreements with pharmaceutical companies — in this case a biotherapeutics company — are considered a third source of revenue.

Genetic Analysis was founded in 2008 to commercialize technology developed at the Norwegian University of Life Sciences.

Its method consists of several steps. First, total bacterial DNA is extracted from a stool sample and disrupted mechanically with magnetic beads, after which the 16S rRNA gene is amplified. Earlier this year, Genetic Analysis announced a licensing agreement with Applied BioCode, that gives Genetic Analysis the ability to use Applied BioCode's magnetic barcode bead technology and instruments in its offering.

Genetic Analysis 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 Stenersen, the firm's platform is currently available for "routine use, in diagnosis and monitoring of dysbiosis in IBS and IBD patients," though in the future it will be offered for other indications. The company aims to introduce its product to the US market next year, with the ultimate goal of attaining FDA clearance for the test, though Stenersen did not provide a timeline for when that might occur.

She also declined to comment on how Genetic Analysis' relationship with Rebiotix might impact any submission to the FDA for the GA-map dysbiosis test.

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