Brian Buntz, managing editor of MDDI, attended the "Diagnostics and Personalized Medicine" session at the OneMedForum San Francisco 2012 conference and submitted the following notes:

We are entering the era of personalized medicine, according to the panelists at a session aptly titled “Diagnostics and Personalized Medicine” at the OneMedForum in San Francisco. The age of one-size-fits-all medicine can’t be sustained. And as progress is made in this area, in the not too distant future, there is a very real chance that cancer can be viewed and treated not as a possible death sentence but as a chronic disease.

Another trend in diagnostics is that there is a growing amount of collaborations among stakeholders active in related areas. For instance, in the past, many academic researchers working on diagnostics didn’t want to become involved with business because of the fear that doing so might contaminate their ideas. This is changing now as the focus on improving patient care becomes clearer.

While the funding market is still tough for young companies, assuming a belief in survival of the fittest, the best ideas will get funded. It is still possible to find funding if an improved patient outcome can be demonstrated. However, it clearly takes a lot of time and research to prove that. “That’s the challenge,” said panelist Yves Dubaquie, PhD, director of business development and licensing at Novartis Molecular Diagnostics.

Panelist Ann Hanham, managing director of Burrill & Co., explained that her company schedules an annual event with members of FDA. Despite ongoing concerns about the regulatory environment in the United States, Harnham has noted a softening at the agency, which is trying to be more thoughtful.

In years to come, a growing share of innovation in the diagnostic sector is likely to come from outside of the United States. There are great technologies being developed around the world, from South America and Asia, one panelist noted. Brazil, Russia, India, and China—the so-called "BRIC" countries—are also becoming increasingly important.

Europe is where most new oncology products are going because of concerns about FDA’s policies. As a result of this, the continent will likely become a more important place to invest in years to come.

Another trend is that value pricing for diagnostics is growing more common owing to growing pressure from CMS. It is also vital that companies in the diagnostic sector focus on their reimbursement strategy from “day one,” the panelists agreed.

Many companies looking for funding that make their pitch to venture capitalists have not given their reimbursement strategies sufficient attention. Once a company is up and running, it should plan on a big percentage of its staff being allocated to reimbursement. Companies with great technology that lack good reimbursement strategies generally fail.

Speaking of reimbursement, that is a topic undergoing a sea change. The Centers for Medicare and Medicaid Services (CMS) has complained that it sometimes does not know what it is paying for. As a result, CMS will debut new diagnostic oncology codes for reimbursement in 2013.

Another important consideration is the explosion of data that will come from increased use of diagnostics. As a growing number of peoples' genomes are sequenced, it is not certain where this massive amount of data will be stored and, once it is, how it will be made available in an easy to digest format for oncologists and other interested parties.