Collaboration, Collaboration, Collaboration: The European Solution | Diaceutics

Collaboration, Collaboration, Collaboration: The European Solution

February 22nd, 2013

Tom Zietlow, PhD, MBA

Tom Zeitlow provides analysis on the recent report by Frost & Sullivan,’European Genetic Testing and Screening Services Market’.

Two things struck me about a recent report from Frost & Sullivan entitled European Genetic Testing and Screening Services Market [2012]. The report found that the European genetic testing and screening services market is poised to take off, driven by the increasing availability of tests covering a wider range of disease areas as testing for genetic diseases has swiftly moved from the laboratory into medical practice, but that reimbursement remains a primary barrier. As Frost & Sullivan Senior Research Analyst, Divyaa Ravishankar, specifically notes, “Varying reimbursement procedures across Europe, however, loom as a major concern to market participants. When samples are being shipped across international boundaries, inadequate reimbursement can result in uneven access to genetic testing services.”

First, it struck me that this report yet again highlights the market shift underway driven primarily by physician demand. As the report noted, “There is a rising interest in predictive testing, which is seen as the highest growth area within genetic testing.” Secondly, it struck me that this demand is again exposing the infrastructure gaps in the EU laboratory market. For more details on this research see

Perhaps we should  pose the question, “for whom are these reimbursement infrastructure gaps a problem?” Of course, diagnostic companies introducing new tests are often frustrated by the national reimbursement structures in most markets outside the US and continue to lobby for change. Whilst this serves to address some gaps on some tests it does not really address the underlying enablement of personalized medicine. Cash-strapped EU governments are not ready any time soon to stick their hand up to fund new predictive or molecular tests (particularly as the price tag associated with them is tenfold higher than previous price points). Ask any laboratory manager outside the US at the minute how much time they spend trying to get adequately reimbursed for the time, effort and commitment to introducing new tests and they will likely shock you with their answer.

The correct answer, naturally, is that infrastructure gaps are a problem for multiple stakeholders in a myriad of ways. It is our view that a solution will ultimately involve a pan-EU and coordinated action. A more immediate stopgap solution lies with coordinated actions between pharma, clinicians, diagnostic companies and, of course, laboratorians on a per disease or indication basis. The strident efforts by Roche to ensure quality BRAF testing (regardless of the platform used) outside the US is available and reimbursed whenever Zelboraf will be requested, should not be seen as the obligation only of a diagnostic company with deep pockets, but rather a role model for such coordinated action among all the interested stakeholders.

This level of industrial and organizational collaboration will not happen on its own. Indeed, our own research on cross industry collaboration highlights critical components of collaboration between competitors. Interestingly, it starts with identifying who the winners will be.


View all blogs

Webinars & Podcasts

August 9th, 2018
Podcast: Oncology Patient Research
Why do we need to talk biomarkers with patients? Senior Director of Market Research at Diaceutics, Marianne Fillion, recently spearheaded an effort to gather insights directly from oncology patients to get an understanding of what they know about ...
April 20th, 2018
Podcast: PM Readiness Report 2018
Peter Keeling discusses the landscape and challenges for precision medicine, companion diagnostics, CDx or biomarker and conduit diagnostics are discussed including global laboratory test data analysis and forecasts for budget impact and value.
View all

Expert Insights

April 19th, 2018
The CMS National Coverage Decision on NGS
I. Introduction On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination (NCD) that cove...
January 19th, 2018
What does the EU IVD Regulation mean for companion diagnostics and LDTs?
Dave Smart, PhD, Director at Diaceutics, discusses the introduction of the EU IVD Regulation. While it is considered a necessary step, the Regulati...
View all expert insights

Competitive Benchmarking Reports

March 16th, 2018
PM Readiness Report 2018 Summary
March 14th, 2017
Pharma Readiness for Diagnostic Integration 2017
View all reports

Case Studies

View all case studies


May 23rd, 2019
Diaceutics reviews the ongoing debate on diagnostics reform legislation
Thought leaders at Diaceutics recently authored a peer-reviewed article that covers the ongoing national debate over diagnostics reform legislation in the United States. The article is now available online ahead of print in the Journal of Molecula...
September 11th, 2018
BRAF mutation testing in melanoma – Poster presented at European Congress of Pathology 2018
BRAF mutation testing in melanoma: a study including Austria, Germany and UK, highlighting concordance for current technologies, and potential requirement of more sensitive technologies in future applications.
View all publications