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A ‘crucial’ partnership
BUFFALO, N.Y.—Empire Genomics has announced the acquisition of an exclusive license for patent-pending novel genomic biomarkers from Atlanta-based Emory University. The biomarkers will be used to develop a molecular diagnostic that ideally would be able to determine ideal therapeutic treatments for sufferers of multiple myeloma, and the team will be moving forward into a Phase II biomarker-driven clinical trial using this technology to secure validation of its ability to predict patient outcomes in new generations of drugs for multiple myeloma.
"This is a meaningful breakthrough in the area of personalized medicine, and we are excited to work with Emory University and Dr. Bernal-Mizrachi to bring it to the market to help oncologists make more informed treatment decisions for this dreadful disease," Anthony Johnson, CEO of Empire Genomics, said in a press release.
Empire Genomics will make use of the test, and others in development, to support and accelerate clinical trials and the development of companion diagnostics for cancer therapies. This test will see use in clinical trials and be launched through clinical labs early next year. The biomarkers are expected to have some potential in additional indications such as lymphoma, and are undergoing investigation in some cancers.
"Developing a clinically validated multiple myeloma cancer theranostic assay with informative data would represent a major breakthrough in improving disease management," Dr. Leon Bernal-Mizrachi, assistant professor of hematology and medical oncology at Emory University School of Medicine, said in a statement. "It would fulfill an unmet medical need to help patients with multiple myeloma better plan treatment options that will help produce the best outcomes."
Diagnostic tests such as these, Johnson says, are crucial.
"I think when you look at the cost of these drugs … I think that having a biomarker that can actually identify which treatment is ideal for a given patient is going to improve healthcare, quality of life, as well as the decision-making process for families and clinicians across the globe," he says.
As for whether he foresees diagnostic tests becoming a key feature in more therapeutic areas, Johnson notes that, "you can't really say which diseases will be amenable to personalized healthcare, but you're definitely going to imagine those out there right now would do well by having a biomarker and more specific treatment."
Approximately 10 percent of blood-based cancers are multiple myeloma, and roughly 21,700 new cases—and 10,710 deaths—are expected in the United States alone for 2012. In this particular cancer, plasma cells in the bone marrow grow uncontrollably and form tumors in the bone, which makes it difficult for the bone marrow to produce healthy blood cells. The cancer is particularly prevalent in the aging population, and while therapeutic advances have led to improved response rates, the treatments come with significant side effects.
There is definite need for such a biomarker for this indication, Bernal-Mizrachi notes, as none yet exists for multiple myeloma that can guide physicians in treatment decisions.
"This biomarker will be the first of its kind, and will be the first that will allow a physician to decide whether or not a patient should be exposed to a certain drug, and will also guide the physician to say which will be the best combination that will be capable of overcoming the resistance inherent by this genetic abnormality," he explains.
Johnson calls academia-industry partnerships such as this "crucial," noting that without the innovation and research focus of academic organizations such as Emory, the biomarker never would have been discovered.
"I think there needs to be a very close linkage between the academic research institutions out there, and translate those into companies like ourselves that are willing to work with them at a very early stage, and then transition these actual technologies into clinically relevant and high-quality assays that are scalable and can be provided in a quality- controlled manner across the globe," he says. "And that's where we see that kind of nexus between the research institutions and the industrial firms such as Empire Genomics."