Utility Before Profitability: The Evolving Evidence Paradigm For Molecular Diagnostics

The standards needed for reimbursement of molecular diagnostics are changing – especially with respect to genomics-based tests, with their potential impact on public health with respect to screening, prevention, and measuring response to treatment, as well as cost. As the complexity of the assay development and launch process has grown, so too has the emphasis on evidence and clinical effectiveness, as well as the importance of finding better ways to align test coding and reimbursement with clinical value. But a lack of coordination across agencies and commercial players makes an assessment of the impact of any changes on evidence demands problematic.

The standards needed for reimbursement of molecular diagnostics are changing – especially with respect to genomics-based tests. As the complexity of the assay development and launch process has grown, so too has the emphasis on evidence and clinical effectiveness, as well as the importance of finding better ways to align test coding and reimbursement with clinical value.

The demise of code-stacking is bringing issues of evidence and coverage into even sharper relief. Code-stacking grew out of attempts...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo 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 Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

Shape Our Content: Take The Reader Survey

 

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

More from In Vivo

Wide Of The Mark: ‘The Worst EU Medtech Predictions Have Not Come True’

 
• By 

Jana Grieb, European regulatory and market access legal expert at McDermott Will & Emery, explains why the healthtech and pharma industries are warming to the new EU health commissioner as he faces calls to make the MDR more “user friendly.”

This Belgian Biotech’s Drug Cocktail Could Help Reverse Muscle Aging

 
• By 

While big pharma pours billions into creating new anti-aging molecules, a Belgian startup has taken a different path: combining existing safe drugs with AI precision. The early results suggest it might be onto something revolutionary.

Rising Leaders 2025: Doxie Jordan, From UNC Graduate To Global Market Strategist

 
• By 

Bristol Myers Squibb executive Doxie Jordan discusses his path to global commercial leadership and the principles guiding pharmaceutical market strategy