Genetic Testing's Regulatory Quagmire

Various government agencies are proposing greater government oversight of genetic testing, with the most controversial recommendation asking the FDA to regulate "home brews," the tests that clinical labs develop in-house for clinical purposes. As implementation plans are hashed out slowly, IVD kit makers and clinical labs see both opportunities and hurdles. Hospital labs are concerned about being overburdened by the new rules, while iVD makers worry that reform would give labs an unfair advantage.

by Wendy Diller

It's been two years since the FDA established an advisory panel to review new genetic tests and longer than that...

More from Business Strategy

Turning Defense Into Attack: Snapshots Of A Changing Medtech Market And How To Respond

 
• By 

Against a backdrop of shifting trade policies, the end of multilateral market approaches and renewed focus on supply chain resilience, medtechs are doubling down on innovation in products and processes – using AI – and keeping unmet needs and outcomes in the center of the target.

AI Agents Set To Reshape Biopharma’s Workforce And Operations

 
• By 

While biopharma companies experiment with genAI, agentic AI is rapidly shifting the work paradigm towards one of autonomous digital workers that can handle entire process flows.

Mapping Biopharma’s AI Strategy: From Custom Datasets to Foundation Models

 
• By 

Biotech companies are pursuing diverse AI strategies beyond expensive custom data generation: foundation model fine-tuning, data-efficient computational methods and targeted proprietary datasets. In Vivo takes a look at some examples.

Late-Stage GLP-1 Drug Trials Outside The Cardiometabolic Space

 
• By 

A look at Novo Nordisk, Eli Lilly and other companies' late-stage clinical studies of GLP-1 drugs in indications ranging from neurodegeneration to oncology, and alcoholic liver disease to autoimmune conditions.

More from In Vivo

Podcast: ADDF’s Karen Harris On Investing In Alzheimer’s Like A VC

 
• By 

A discussion with Karen Harris, CFO of the Alzheimer's Drug Discovery Foundation, about the foundation's investment strategy, biotech and investor sentiment at the recent BIO conference and what innovations give her hope for Alzheimer's patients.

Turning Defense Into Attack: Snapshots Of A Changing Medtech Market And How To Respond

 
• By 

Against a backdrop of shifting trade policies, the end of multilateral market approaches and renewed focus on supply chain resilience, medtechs are doubling down on innovation in products and processes – using AI – and keeping unmet needs and outcomes in the center of the target.

AI Agents Set To Reshape Biopharma’s Workforce And Operations

 
• By 

While biopharma companies experiment with genAI, agentic AI is rapidly shifting the work paradigm towards one of autonomous digital workers that can handle entire process flows.