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Regulatory And Commercial Should Be 'Hand In Hand' For Dx Success, Expert Says

 
• By Hannah Daniel

Considering where and how a test will be used, and what kind of evidence regulators will want before clearing it, is key for developers of at home and point-of-care diagnostics.

• Source: Shutterstock

A diagnostic company’s commercial strategy should inform its regulatory strategy, in-vitro diagnostics expert Joen Johansen said.

Johansen, president and CEO of IVD consultation firm MDC Associates Inc., spoke about regulatory considerations for at home-use and point-of-care (POC) tests at the Next Generation Dx Summit in Washington,...

Key Takeaways:

  • Diagnostics firms should use their commercial strategy to drive their regulatory strategy;

  • Consider the entire usage of a test,...

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