Example · Biotechnology

A stable assay for a degradation-prone biomarker

Meridian needed a reliable assay for a biomarker that degraded quickly in standard sample conditions, producing irreproducible results that no established protocol stabilized.

Meridian Biosciences (fictional). This is a fictional educational example. It is not a customer claim and is not tax advice. It illustrates how to structure and reason about a SR&ED narrative — not text to copy into a claim.

Technological uncertainty (T661 line 242)

Weak

Our assay wasn't giving consistent results so we worked to improve it.

Strong

It was uncertain whether a reproducible assay for the biomarker was achievable given its rapid degradation under standard handling. Established stabilization buffers did not prevent signal loss within the required window, and it was unknown whether any accessible method could hold the analyte stable without interfering with detection.

The strong version names the biological unknown and the fact that the standard fix had already failed.

Technological advancement (T661 line 246)

Weak

We developed an assay that now gives us consistent results.

Strong

We advanced our understanding of stabilizing this analyte class: a two-stage quench combined with a modified extraction held the signal within acceptable variance across replicates, while we established that the conventional cold-chain approach alone was insufficient — a negative result that informed the final protocol.

The strong version reports the methodological knowledge gained and the ruled-out approach.

Evidence matrix

What backs a claim like this

Each claimed element ties to a source that shows it. This is the traceability a review tests.

SourceWhat it shows
Lab notebooksThe dated protocols tried and their reproducibility outcomes
Assay result dataSignal variance across replicates for each approach
Protocol revisionsThe evolution of the method and the reasoning behind each change
Batch recordsThe conditions each experimental run was performed under

The takeaway

Distinguish the experimental development from confirmatory testing. The claim is the work to resolve the unknown, not the routine runs that followed once it was solved.

All examples · SR&ED for biotechnology

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