Lining up with Lineagen

SALT LAKE CITY—Lineagen Inc., a diagnostics company focusingon complex genetic disorders, has joined forces with Fast Forward LLC, anonprofit subsidiary of the National Multiple Sclerosis Society (NMSS), in anew alliance aimed at developing a blood-based assay for multiple sclerosis(MS). The program will seek to develop a test that can aid clinician diagnosisof MS, providing an earlier diagnosis and allowing treatment decisions to bemade earlier.

Per the terms of the sponsored research agreement, FastForward will fund $622,000 to establish and validate an array of biomarkers forMS, which will include genes associated with a predisposition to the disease aswell as blood-based markers with diagnostic and prognostic potential. Thefunding will support Lineagen's ongoing clinical program, which is beingperformed by the teams of University of Utah faculty members Dr. John W. Rose,a professor of neurology, and Dr. Mark Leppert, a professor of human genetics.Lineagen will handle research, development and commercialization for theprogram.

"We are pleased to partner with Lineagen in the advancementof its innovative technology for MS," Dr. Timothy Coetzee, chief researchofficer at the NMSS, said in a press release. "Fast Forward's partnership withLineagen reflects our commitment to create new tools and technology to assistphysicians in making diagnostic and treatment decisions that will improve thequality of life for people living with this disease."

Coetzee says that with its strong financial backing andtrack record of developing lab-based tests and kits, as well as the strongscientific leadership they have in Drs. Rose and Leppert, Lineagen represented"the right team" for developing biologically based tests, adding that Lineagenalso has "an excellent cohort of patients" as well as "really interestinggenetic and biological marker technology."

"It's our sense that we need to have a laboratory-based testthat can help either confirm the diagnosis for MS … and this is where we seesignificant value, is to allow for the development of tailored treatmentapproaches," Coetzee says. "So that if you could begin to understand what wouldbe a person's disease progression rate, or if they have a particular geneticprofile, are they more likely to progress or be responsive to a particulartherapy—that kind of personalized medicine approach for MS is still very muchin its infancy."

Coetzee adds that while there has been a good deal oflaboratory work to that end, "there hasn't really been a focused effort bycompanies of yet—that has come to fruition, anyway—that have been able to takesome of that good science and translate it into technology on a consistentbasis."

Dr. Michael Paul, president and CEO of Lineagen, says thecompany began its broad partnership in MS with the University of Utah in 2007,with a sponsored research and licensing agreement in collaboration with Roseand Leppert. He says the program is on target in terms of its timeline, andthat they have identified regions of the genome they believe have not yet beenidentified in association with MS. In addition, Paul adds that they are ontarget for validating their protein markers as well as confirming geneticmarkers for the next-generation sequencing project.

"The way we're approaching it with access to these uniqueresources will enable us, enable Lineagen and the Fast Forward partnership, toidentify novel genetic factors associated with MS and then to associate thosegenetic factors with circulating protein factors in combination to produce aunique panel, if you will, a panel of markers that might be more informativethan just a protein panel or a genetic panel on their own," Paul explains.

He says the advanced notice an MS assay could provide is oneof its strongest features, citing that there is "a real market need for theearlier assessment." Being able to identify the clinical course of a patientahead of a full diagnosis of MS, "just to inform the clinician that Patient Amight be on a certain trajectory towards disease that could differ from PatientB," could lead to earlier intervention, Paul says, especially since "there area lot of good drugs on the market, a lot of good drugs in development, thatcould affect the course of disease if these patients could be assessedearlier."

"The market opportunity, to speak generally, is theacceleration and enhancement of the diagnostic evaluation process," says Paul."Not just a 'yes, no' diagnosis, but a more informed process."