Evidence map›Paper›PMID 42228252›Full record

ArticleThe AAPS journal2026

Context-of-use-Guided Development and Validation of a Transthyretin Immunoassay: A Framework for Biomarker Assay Design.

Tanya Watanabe, John Canfield, Erin Anderson, Leighla Tayefeh, John L Allinson, Nicholas J Viney, Joel A Mathews

Abstract readValidation Study
PubMed Publisher
In one paragraph

Article in The AAPS journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Tanya WatanabeIonis Pharmaceuticals, Carlsbad, California, USA.ORCID http://orcid.org/0009-0009-2193-9168
John CanfieldImmunologix Laboratories, Tampa, Florida, USA.ORCID http://orcid.org/0009-0003-6859-7800
Erin AndersonImmunologix Laboratories, Tampa, Florida, USA.ORCID http://orcid.org/0009-0001-0714-4774
Leighla TayefehIonis Pharmaceuticals, Carlsbad, California, USA.ORCID http://orcid.org/0009-0001-8302-8118
John L AllinsonImmunologix Laboratories, Tampa, Florida, USA.ORCID http://orcid.org/0000-0002-9375-8026
Nicholas J VineyIonis Pharmaceuticals, Carlsbad, California, USA.ORCID http://orcid.org/0009-0000-5080-3037
Joel A MathewsIonis Pharmaceuticals, Carlsbad, California, USA. jmathews@ionis.com.ORCID http://orcid.org/0000-0002-5535-8080

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Transthyretin (TTR) is a circulating protein biomarker central to the evaluation of therapies for transthyretin amyloidosis. Clinical trials with Eplontersen, a TTR-targeting antisense oligonucleotide, required an assay with a context of use differing from existing assay, requiring a more sensitive method. This study describes the development, optimization, and validation of a quantitative immunoassay for TTR, guided by a context-of-use framework. Method development focused on calibration curve modeling, weighting, parallelism, and determination of the minimal required dilution. Antibody selection and calibrator characterization followed established best practices. Pre-validation experiments optimized antibody concentrations and curve-fitting (five-parameter logistic with 1/y

Indexed as

Amyloid Neuropathies, FamilialPrealbuminBiomarkersCalibrationHumansImmunoassayReproducibility of ResultsBiomarkersPrealbuminTTR protein, humanATTRdevelopmentTTRvalidation

Identifiers

PMID42228252

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.