A ‘crucial’ partnership

Empire Genomics, Emory University to develop multiple myeloma molecular diagnostic

Kelsey Kaustinen
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BUFFALO, N.Y.—Empire Genomics has announced the acquisitionof an exclusive license for patent-pending novel genomic biomarkers fromAtlanta-based Emory University. The biomarkers will be used to develop amolecular diagnostic that ideally would be able to determine ideal therapeutictreatments for sufferers of multiple myeloma, and the team will be movingforward into a Phase II biomarker-driven clinical trial using this technologyto secure validation of its ability to predict patient outcomes in newgenerations of drugs for multiple myeloma.
"This is a meaningful breakthrough in the area ofpersonalized medicine, and we are excited to work with Emory University and Dr.Bernal-Mizrachi to bring it to the market to help oncologists make moreinformed treatment decisions for this dreadful disease," Anthony Johnson, CEOof Empire Genomics, said in a press release.
Empire Genomics will make use of the test, and others indevelopment, to support and accelerate clinical trials and the development ofcompanion diagnostics for cancer therapies. This test will see use in clinicaltrials and be launched through clinical labs early next year. The biomarkersare expected to have some potential in additional indications such as lymphoma,and are undergoing investigation in some cancers.
"Developing a clinically validated multiple myeloma cancertheranostic assay with informative data would represent a major breakthrough inimproving disease management," Dr. Leon Bernal-Mizrachi, assistant professor ofhematology and medical oncology at Emory University School of Medicine, said ina statement. "It would fulfill an unmet medical need to help patients withmultiple myeloma better plan treatment options that will help produce the bestoutcomes."
Diagnostic tests such as these, Johnson says, are crucial.
"I think when you look at the cost of these drugs … I thinkthat having a biomarker that can actually identify which treatment is ideal fora given patient is going to improve healthcare, quality of life, as well as thedecision-making process for families and clinicians across the globe," he says.
As for whether he foresees diagnostic tests becoming a keyfeature in more therapeutic areas, Johnson notes that, "you can't really saywhich diseases will be amenable to personalized healthcare, but you'redefinitely going to imagine those out there right now would do well by having abiomarker and more specific treatment."
Approximately 10 percent of blood-based cancers are multiplemyeloma, and roughly 21,700 new cases—and 10,710 deaths—are expected in theUnited States alone for 2012. In this particular cancer, plasma cells in thebone marrow grow uncontrollably and form tumors in the bone, which makes itdifficult for the bone marrow to produce healthy blood cells. The cancer isparticularly prevalent in the aging population, and while therapeutic advanceshave led to improved response rates, the treatments come with significant sideeffects.
There is definite need for such a biomarker for thisindication, Bernal-Mizrachi notes, as none yet exists for multiple myeloma thatcan guide physicians in treatment decisions.
"This biomarker will be the first of its kind, and will bethe first that will allow a physician to decide whether or not a patient shouldbe exposed to a certain drug, and will also guide the physician to say whichwill be the best combination that will be capable of overcoming the resistanceinherent by this genetic abnormality," he explains.
Johnson calls academia-industry partnerships such as this"crucial," noting that without the innovation and research focus of academicorganizations such as Emory, the biomarker never would have been discovered.
"I think there needs to be a very close linkage between theacademic research institutions out there, and translate those into companieslike ourselves that are willing to work with them at a very early stage, andthen transition these actual technologies into clinically relevant andhigh-quality assays that are scalable and can be provided in aquality-controlled manner across the globe," he says. "And that's where we seethat kind of nexus between the research institutions and the industrial firmssuch as Empire Genomics."

Kelsey Kaustinen

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