OnCo
ideasIdea

Record how long tissue waited before fixation in every pathology report

How a tissue sample is handled before it reaches the lab changes the results of biomarker tests. That handling time is almost never recorded, so nobody can tell a true negative from a spoiled sample.

Cold ischaemia time and fixation duration affect phosphoprotein, RNA and even some IHC markers (including HER2 and ER), yet pre-analytical variables are rarely recorded in structured form. Guidelines (ASCO/CAP for HER2) specify limits but compliance is unmeasured. Adding mandatory structured fields for time to fixation and fixation duration to pathology reporting standards and laboratory information systems would let biomarker results be interpreted, audited and used in research.

Hypothesis
Once recorded, pre-analytical time will explain a measurable share of the between-hospital variation in biomarker positivity rates, and hospitals with out-of-range times will improve within a year of feedback.
Rationale
Clinical chemistry rejects samples with documented pre-analytical faults; anatomic pathology has no equivalent because the data are not captured.
What would test it
Implement the fields in five hospitals; correlate recorded times with HER2 and ER positivity rates and with repeat-test rates.
Maturity
speculative
Who has to act
clinic
Cost to try
Small (under $1M)
Years to first evidence
2
Bottlenecks it attacks

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Pages like this

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technologies

1
Histopathology & immunohistochemistry

terms

1
Immunohistochemistry (IHC)

ideas

1
Publish each laboratory's biomarker proficiency results

bottlenecks

1
Biomarkers are not validated or standardised