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Unmet Needs In Infectious Disease Testing
Despite decades of scientific progress, many infectious diseases still lack:
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Fast, accurate diagnostics for all clinical settings
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Tests for neglected or emerging pathogens
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Tools that are affordable and scalable
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Options for diverse settings (rural, low-resource, home)
You can’t treat what you can’t diagnose — and you can’t stop what you can’t find.
Why the Gaps Exist
The diagnostic gap isn’t always about the science — it’s often about:
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Regulatory complexity: Long, expensive approval processes
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Low commercial return: Rare diseases ≠ big markets
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Fragmented development: Many tools get stuck in research
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Lack of integration: Diagnostics aren't always linked to treatment access or designed to fit a clinical workflow
At the end of the day, successful new diagnostics, fill a need that fits the right setting, are medically justifiable they need to be used in and have passed all regulatory hurdles. No easy feat!
What’s Emerging
We’re seeing exciting trends like:
Software as a Medical Device (SaMD) — using AI to interpret test results
Molecular multiplexing — detect multiple pathogens at once
Portable diagnostics — field-ready devices for outbreak response and even at-home testing
Microbiome and host-response testing — beyond just pathogen detection
What Developers Should Know
Citizen Science Considerations
