Evidence map›Paper›PMID 40248960›Full record

ArticleBioanalysis2025

Recommendations on biomarker assay validation (BAV) in tissues by GCC.

Moucun Yuan, Aihua Liu, Bin Xu, Kurt Sales, Shane Karnik, Troy Voelker, Danielle Salha, Jennifer Zimmer, Mark O'Dell, Shashank Gorityala and 57 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Bioanalysis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

67 authors.

Moucun YuanPPD, part of Thermo Fisher Scientific, Richmond, VA, USA.
Aihua LiuResolian, Malvern, PA, USA.
Bin XuAccurant Biotech, Cranbury, NJ, USA.
Kurt SalesAgilex Biolabs, Adelaide, Australia.
Shane KarnikAliri Bioanalysis, Colorado Springs, CO, USA.
Troy VoelkerAliri Bioanalysis, Salt Lake City, UT, USA.
Danielle SalhaAltasciences, Laval, QC, Canada.
Jennifer ZimmerAlturas Analytics, Moscow, ID, USA.
Mark O'DellB2S Life Sciences, Franklin, IN, USA.
Shashank GorityalaBioAgilytix, Durham, NC, USA.
Amanda HaysBioAgilytix, Durham, NC, USA.
Todd LesterBioAgilytix, Durham, NC, USA.
Gregory ReynoldsBioAgilytix, San Diego, CA, USA.
Magdalena Tary-LehmannCellular Technology Ltd, Beachwood, OH, USA.
Mathilde YuCerba Research Canada Formally CIRION BioPharma Research Inc, a Cerba Research Company, Laval, QC, Canada.
Martin RobergeCerba Research Canada Formally CIRION BioPharma Research Inc, a Cerba Research Company, Laval, QC, Canada.
Katherine MaloneCharles River Laboratories, Reno, NV, USA.
Vimal PatelCharles River Laboratories, Reno, NV, USA.
Iain LoveCharles River Laboratories, EdinburgTranent, UK.
Jenny LinCMIC, Hoffman Estates, IL, USA.
Manisha DiazEurofins Viracor BioPharma Services, Lenexa, KS, USA.
Tao XuFrontage Laboratories, Exton, PA, USA.
Wei GarofoloGCC, Toronto, ON, Canada.
Jessica McGregorGCC, Toronto, ON, Canada.
Amanda LeskovarICON, Whitesboro, NY, USA.
Robert KernstockICON, Whitesboro, NY, USA.
Mario PellerinICON, Whitesboro, NY, USA.
Michael BrownIQVIA Laboratories, Durham, NC, USA.
Adriane SpytkoIQVIA Laboratories, Ithaca, NY, USA.
Stephen LowesIQVIA Laboratories, Ithaca, NY, USA.
David AmbroseKCAS Bio, Olathe, KS, USA.
Dawn DufieldKCAS Bio, Olathe, KS, USA.
Cheikh KaneKCAS Bio, Olathe, KS, USA.
Rathna VeeramachaneniKCAS Bio, Olathe, KS, USA.
Marsha LunaKCAS Bio, Olathe, KS, USA.
Dominic WarrinoKCAS Bio, Olathe, KS, USA.
Varun DwivediKCAS Bio, Spring House, PA, USA.
Allan XuKeystone Bioanalytical, North Wales, PA, USA.
Elizabeth HyerLabcorp, Madison, WI, USA.
Tracy IlesLabcorp, Harrogate, UK.
Ritankar MajumdarLabcorp, Chantilly, VA, USA.
Daniel SikkemaLabcorp, Chantilly, VA, USA.
Eric ThomasLabcorp, Indianapolis, IN, USA.
Annika CarlssonMercodia AB, Uppsala, Sweden.
Naveen DakappagariNavigate BioPharma Services, Inc. (A Novartis Subsidiary), Carlsbad, CA, USA.
Nathan RiccitelliNavigate BioPharma Services, Inc. (A Novartis Subsidiary), Carlsbad, CA, USA.
Chantal Di MarcoPharma Medica Research, Mississauga, ON, Canada.
Mohammed BouhajibPharma Medica Research, Mississauga, ON, Canada.
Adriana IordachescuPharma Serv International, Bucharest, Romania.
Mitesh SanghviPharmaron, Germantown, MD, USA.
Hollie BartonPPD, part of Thermo Fisher Scientific, Richmond, VA, USA.
Amy LavellePPD, part of Thermo Fisher Scientific, Richmond, VA, USA.
Elizabeth DompkowskiPPD, part of Thermo Fisher Scientific, Richmond, VA, USA.
Stephen RundlettPrecision for Medicine, Redwood City, CA, USA.
Katie MatysResolian, Malvern, PA, USA.
Tim SangsterResolian, Fordham, UK.
Annelies TurksmaSanquin Diagnostic Services, Amsterdam, Netherlands.
Weihua GuShanghai Xihua Scientific Co, Shanghai, China.
Jia LiuShanghai Xihua Scientific Co, Shanghai, China.
Brian HoffpauirSmithers, Gaithersburg, MD, USA.
Agostinho RochaSmithers, Ewing, NJ, USA.
John PirroSword Bio, Long Branch, NJ, USA.
Jerome BergeronSyneos Health, Quebec City, QC, Canada.
Kyla O'BrienSyneos Health, Princeton, NJ, USA.
Xinping FangTri-Apex Inc, Plainsboro, NJ, USA.
Kelly DongUnited-Power Pharma Tech Co, Beijing, China.
Jim YamashitaWuXi AppTec, Plainsboro, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Biomarker analysis enables a deep understanding of physiological and biological processes and offers insights into pathological disease states and conditions. When measured in tissues, the spatial distribution of biomarkers may be evaluated. To meet regulatory and sponsor requirements, guidance on the approach to validation and the parameters to be evaluated is essential. The main goals of this GCC white paper are to disseminate the survey results discussed during the 16

Indexed as

Biological AssayBiomarkersHumansValidation Studies as TopicBiomarkersBAVbiomarker assay validationBiomarkersGCCglobal CRO council in bioanalysistissues

Identifiers

PMID40248960
PMCPMC12026151

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.