Epigenomics Finally Gains FDA Approval For Epi proColon Blood Test

Epigenomics has finally gained US FDA approval for its Epi proColon noninvasive colorectal cancer screening test, ending what has been a long, obstacle-filled journey for the German-US molecular diagnostics company.

Epigenomics AG has finally gained US FDA approval for its Epi proColon noninvasive colorectal cancer screening test, ending what has been a long, obstacle-filled journey for the German-US molecular diagnostics company.

The approval makes Epi proColon, which detects Septin9 gene methylation in DNA isolated from the patient’s plasma, the first and...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Germany

A Deregulated Medtech Sector Could Flourish In Merz’s Industry-Friendly Germany

 
• By 

Less bureaucracy, no more national supply chain law, framework agreements and competition for direct reimbursement of medtech innovations are among the positive changes the local medtech industry might expect as Germany’s new government gets down to work. Life sciences lawyer Gunnar Sachs offers a view from the ground.

Keeping Germany’s Medtech Industry Apprised, Advised and Incentivized in Turbulent Times

 
• By 

A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.

Medtech Strategy Must Be Priority, German Diagnostics Firms Tell Government

 
• By 

Germany’s incoming coalition government has reacted positively to industry’s calls for a dedicated medtech strategy to boost economic growth. Faster digitization, lower energy costs and “IVDR 2.0” are also on the in vitro diagnostic industry’s agenda.

Medtechs Eye German Health Minister Switch As Governing Parties Reach Coalition Agreement

 
• By 

The architect of Germany’s hospital reform, Karl Lauterbach, will not be retained as health minister according to how the new CDU/CSU-SPD coalition government plans to spread the ministerial portfolios.

More from Europe