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MDx/CDx Focus: MDxHealth Gains Access to Japanese CDx Market; UF Awarded NHGRI Grant


MDxHealth Gains Access to Japanese Pharmas Interested in Personalized Rx Development

MDxHealth has signed a deal with Summit Pharmaceuticals that will enable the molecular diagnostics firm to work with Japanese drug makers interested in advancing personalized treatments with companion tests.

Summit is a subsidiary of Sumitomo Corporation, which has 140 locations in 66 countries. Summit provides drug discovery research and production services in Japan.

MDxHealth CEO Jan Groen said in a statement announcing the partnership that the diagnostic company will work with Summit to provide epigenetic companion diagnostic products and services to drug development firms.

The partners didn't disclose the financial terms of their agreement.

MDxHealth currently markets a test called ConfirmMDx for Prostate Cancer, which detects an epigenetic "field effect" or "molecular halo" around a cancer lesion that can be present despite it appearing normal under a microscope. MDxHealth has launched the test as a tool to help urologists determine whether prostate cancer-free men can avoid biopsies and if high risk patients need repeat biopsies and aggressive treatment (PGx Reporter 2/13/2013).

MDxHealth worked with Merck to provide centralized companion diagnostic testing for a global Phase III clinical trial involving Merck's glioblastoma drug cilengitide. For the trial – which ultimately failed to show that cilengitide increased survival in patients compared to temozolomide and radiotherapy – MDxHealth tested around 3,500 patients for methylated MGMT, which past studies have suggested makes tumor cells more sensitive to chemoradiation (PGx Reporter 6/5/2013).

UF Receives NHGRI Grant to Expand Personalized Rx Program

University of Florida has received a $3.7 million grant from the National Human Genome Research Institute to expand its genomically-guided personalized medicine program.

A year ago, UF launched a personalized medicine program in which all patients visiting its catheterization lab would receive a multi-gene test that doctors used to gauge whether they will respond to the anti-platelet drug Plavix and other treatments (PGx Reporter 6/27/2012). Approximately 1,000 heart patients have participated in this program to date, and 28 percent have received a different treatment based on genetic test results.

The latest NIH funding will allow UF to expand this program over the next four years, and improve physicians' ability to individualize a broader range of drugs, including medications for pediatric cancer patients, as well as adult and pediatric gastroenterology patients.

Additionally, with this funding, UF will help move its personalized medicine program beyond the academic setting. UF plans to help implement genetic testing programs at two cardiology practices at Orlando Health in 2014. UF will also work with Florida State University's College of Medicine to set up a similar testing program within its network of community physicians' practices.

For its personalized medicine program, UF has set up a system where its pathology lab processes blood samples, interprets test results, and stores patients' data within the university's electronic medical records within 24 to 48 hours. This ensures that the EMR system can alert doctors with recommendations based on patients' genetic test data at the time they are being seen by the physician. With the NIH funds, UF will help external partners set up similar infrastructure to process patients' blood samples and quickly input the data in the EMR.

“UF Health was the perfect testing ground for understanding how to execute the program and get it to work,” David Nelson, director of the UF Clinical and Translational Science Institute, said in a statement. “Now we can offer that technology and know-how out to the state.”