Bridesmaid No More: It is Time For Diagnostics To Shine

stakeholders understand the power of fully informed diagnostics. Too few physicians are totally confident in today’s diagnostic tools, too few policymakers fully appreciate the impact of diagnostics, and too few payers consider diagnostics “money well spent.”

To persuade stakeholders to adopt value-driven diagnostics into the healthcare value chain, we must educate to overcome the inertia around four key barriers:

1. Limited funding for innovation: The venture capital and private equity sectors are hesitant to invest in small companies that develop precision diagnostics and technologies, even though these organizations engender significant innovation.

2. Ambiguous (at best) healthcare regulation: Although the FDA has made strides in developing draft guidelines in recent years, they remain in draft form and thus the future approval pathway for diagnostics and companion diagnostics is unclear.

3. Insufficient reimbursement for diagnostic tests: The current coding and payment systems do not accurately describe novel diagnostics, reflect the value to patients, or account for the need for increased development resources to support strong claims.

4. Slow market adoption of novel diagnostics: Physicians must be educated to put their trust and confidence in diagnostic technologies that demonstrate potential to advance patient care. Education is paramount to accelerate market adoption of these valuable technologies.

The critical need for education to lift these barriers has led to a revolutionary alliance of the diagnostics community. Diagnostic stakeholders have joined together to create DxInsights in order to illuminate providers, policymakers, payers, investors, and patients about the important capabilities of diagnostics available today, ways to lift these barriers through education and research for all stakeholders, and promote the promise of an even greater future. It is time for diagnostics to step out of the shadows and be recognized for the value it brings. It is time for diagnostics to shine.

For more information, please visit the DxInsights website.

Author: Kristin Pothier

Kristin leads the Diagnostics and Life Sciences Practice at Health Advances, a global practice which meshes her consulting and scientific experience to provide results-oriented commercialization strategies for her clients in the biotech and clinical diagnostics sectors, including focus on launch strategy, pricing, and R&D prioritization for novel diagnostics and biotech platforms for the research laboratory, personalized medicine, point-of-care, and mainstream clinical diagnostics. Kristin is a noted speaker, workshop leader and writer in the diagnostics and life sciences industries, covering topics such as the future of point-of-care platforms, the commercialization of companion diagnostics, and innovations in personalized medicine. She is also a founder of DxInsights, a non-profit organization designed to educate on the impact of diagnostics in improving healthcare outcomes to the nation's healthcare communities. Kristin has over 16 years of experience in the diagnostics and drug discovery industries. Prior to joining Health Advances in 2002, Kristin was a scientist in diagnostics technology development at Genzyme and genomics research at Genome Therapeutics. She has an undergraduate degree in Biochemistry from Smith College and a Masters degree in Epidemiology, Health Management, and Maternal and Child Health from the Harvard School of Public Health.