Bringing personalized medicine to the market

Jan Groen, MDxHealth CEO

Personalized medicine has been the holy grail of diagnostics and biomarkers for some time, but at last, it seems like it is becoming a reality. Jan Groen, CEO at MDxHealth, spoke to FierceBiomarkers at BIO2012 about this growing field.

The move toward personalized medicine is driven by a number of factors--insurance companies; desire to select responders as their drug bills increase, and new FDA guidelines supporting the use of biomarkers in new drug development. However, the science is also a driving force, as more biomarkers are discovered every week.

The biggest area in diagnostics for personalized medicine is going to be oncology, Groen predicts. "Currently, around 90% of the diagnosis of cancer is made using microscopes, but this will change, as molecular diagnostics replace, or supplement, pathology. It's a big opportunity."

Some biomarker-driven tests are already on the market--MDxHealth ($MDXH) has launched ConfirmMDx for prostate cancer, which is designed to confirm the results of biopsies. Currently around 1.5 million men a year in the U.S. who have increasing levels of PSA (prostate-specific antigen) but have a negative biopsy will have to undergo repeat biopsies, each of which will involve taking 10 or 12 samples. MDxHealth's epigenetic test can use the existing biopsies, rather than needing fresh tissue samples. It is designed to either confirm a negative result, giving the physician and patient peace of mind and eliminating the need for further biopsies, or guide treatment by indicating the location of the tumor in the 25% of men whose biopsies come up negative but miss hidden cancers. This test will be followed by InformMDx to determine which prostate cancers will become aggressive and need treatment and which can simply be monitored.

Personalized medicine will, according to Groen, become a key part of healthcare, through screening and prevention, but physicians will need to be educated in the new methods. The secret to success is likely to be to follow and add to the current practices of diagnostic sampling, rather than moving suddenly to new and unfamiliar processes.

"The challenges to personalized medicine will be introducing new methodologies and getting reimbursement, particularly in Europe, where the market is less unified than the U.S. But it's still a very exciting place to be in, with a lot of opportunities," concludes Groen.