Custom assay design is your first inflection point. Are you asking the right questions?

Novel therapeutics demand novel measurements. The assays you need often don't yet exist. Inside this brief, we walk you through five critical questions that clarify whether off-the-shelf tools will work for your program—or whether custom assay design is essential.
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Choosing the wrong path early costs months later

The decision happens fast. You're 6-9 months from IND. You know what you want to measure. So you look for an assay—and either force-fit something close enough, or realize nothing exists. By then, you're already behind. Today's developers are navigating:

  • Novel mechanisms (cell therapy, gene therapy, advanced modalities) where standard assays don't apply
  • Regulatory questions that diagnostic platforms can't answer with precision
  • Pre-clinical to clinical consistency requirements that demand assay planning from day one
  • Timeline pressure that makes assay validation feel like a luxury rather than infrastructure
  • Lab partners who understand the science but miss the regulatory expectations baked into design
custom-assay-design-where-scientific-creativity-meets-regulatory-precision

hVIVO Delivers Clarity on Custom Assay Design

This brief outlines five questions that clarify your path. It's grounded in years of working with sponsors across infectious disease, immunology, oncology, and advanced modalities. Some programmes need custom design. Others don't. But you need to know which one is yours before you commit.

One brief. Five questions that change everything.

What Specific Question Are You Trying to Answer?

Not how to measure X, but what the regulator needs to see to move forward. Mechanistic questions rarely have off-the-shelf answers.

Is Your Therapeutic Novel Enough That Standard Assays Don't Fit?

Cell therapy, gene therapy, ADC, novel antiviral—if you're the first to ask this question, custom development is likely necessary.

When Do You Need This Validated?

Timeline shapes everything. Custom assay development takes time. Know your IND/IMPD/Phase pathway before scoping the project.

How Long Do You Need This Assay to Last?

One-off exploratory test, or infrastructure spanning pre-clinical through Phase III? This changes how you approach design.

Do You Have a Lab Partner With Multi-Platform Expertise?

Custom design requires integration across molecular, cell-based, ligand binding, immunology, possibly microbiology. Breadth matters.

Built by the Scientists Behind hVIVO's Laboratory Programme

The expertise in this brief comes from hVIVO's infectious disease and immunology heritage, extended across oncology, autoimmune, and advanced modalities. Our laboratory leadership brings decades of experience in custom assay development, regulatory strategy, and translational science. We lead hVIVO's laboratory services with a team of specialist scientists working across virology, molecular biology, immunology, and microbiology.