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Rules-Based Medicine in First Marketing Deal, With Charles River, for Animal Profiling

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Last fall, Rules-Based Medicine, of Austin, Texas, left the shelter of its parent company Luminex to provide tests for biochemical markers that use Luminex’s bead-based xMAP technology. The 16-employee spinoff, which is ten percent owned by Luminex, and headed by Luminex founder and former CEO Mark Chandler, started offering testing services in October.

Last week, RBM announced its first marketing deal, with Charles River Laboratories in Wilmington, Mass., thereby potentially increasing its customer base. “It is an important step for us,” said Craig Benson, RBM’s president and COO, “with Charles River’s market leadership and depth within the animal sector, and their relationship with their customers and breadth of other services.”

Charles River claims global market leadership in the commercial production and supply of laboratory research animal models. Eighty percent of CRL’s customers are pharmaceutical and biotechnology firms, according to the company, with the remainder being academic and government research institutions.

Under the agreement, Charles River will exclusively offer RBM’s panel of assays for the analysis of mouse and rat samples. The companies will share revenue.

To date, this panel includes 88 analytes, among them plasma proteins like hormones, cytokines, and chemokines, as well as a variety of viruses. According to Ralph McDade, RBS’ strategic development officer and former CSO of Luminex, these analytes were selected based on demand from pharmaceutical researchers and the availability of testing reagents, and additional analytes will be added in the future. All tests have been validated in plasma, “the most challenging matrix to do assays in,” he said.

At present, customers will have a choice between testing for all 88 markers, priced at $325, or two subsets, priced at $200 and $250. Charles River will send the samples to RBM, where they will be analyzed in an automated system that currently runs close to 24 hours a day, according to McDade.

The results of these tests are meant to help researchers characterize animal models, like transgenic mice, and find biomarkers associated with certain diseases in those animals. “[This gives] the client a broader view of his research animal, all toward the goal of making [it] more specific to a human disease state,” said Julie Palm, senior vice president for biomedical products and services at CLR.

The xMAP technology, developed by Luminex, uses up to 100 types of microspheres, each labeled with a different fluorescent signature. Coupled to each type of bead is a specific capture antibody that binds to an analyte, which can in turn be detected by a fluorescently labeled reporter antibody. After reacting with the sample in solution, the beads are run in single file through the path of two lasers that detect and quantify each type of analyte.

Compared to a traditional ELISA, the main advantage of this technology lies in the lower sample volume required and the lower cost of the assays, while their sensitivity and time to perform are comparable. “We can do the entire test [of 88 analytes] on 8 microliters of plasma,” said McDade.

Charles River decided to incorporate RBM’s test panel into its offerings partly because it “happens to be a very good fit, technology-wise, with what we do in our laboratory in Wilmington, where we do a lot of serology testing on rodents,” said Palm. Furthermore, Charles River has been a long-standing partner and customer of Luminex, and was already familiar with the technology, according to Benson.

Going forward, Charles River is planning to offer smaller segments or “mini-screens” of the total profile, according to Palm, “because we expect that … researchers may want all [the assays], or they might want a subset.”

Based on prior experience with new offerings, Palm expects the new service to catch on slowly initially, and gain momentum after the first year. The company has observed that 5-10 percent of its current clients pick up a new service in the first year. Benson declined to specify how much he expects the arrangement to contribute to RBM’s total revenues.

Rules-Based Medicine will continue to offer its services for analyzing human samples independently. Its human assay panel includes 166 analytes to date, which the company determines from 20-25 microliters of plasma at a price of $450 per sample. Its customers include “a number of” major pharmaceutical companies, as well as research institutions, according to Benson, and the company plans on “continuing to roll out the fee-for service-business,” he said.

In addition, RBM is involved in several research projects, both with academic groups and companies, to discover biomarker patterns for different disease states — including asthma, transplant rejection, and multiple sclerosis — in blood samples from patients. RBM plans to patent these biomarkers and license them to pharmaceutical or diagnostic companies for further development, Benson said.

— JK

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