Flagship Biosciences
Tissue-based biomarker and digital pathology laboratory providing IHC, multiplex imaging and image analysis for drug development.
About Biomarker Analysis
Preclinical biomarker work measures the molecular, cellular or physiological signals that show a drug is reaching its target and having the intended effect, or that flag toxicity early. Pharmacodynamic biomarkers link exposure to response, while safety biomarkers such as cardiac troponins or kidney injury markers can detect organ damage before it shows up in histopathology.
Platforms range from immunoassays (ELISA, MSD, Simoa) and flow cytometry to qPCR, LC-MS/MS and immunohistochemistry. Many commercial kits are built for human samples, so cross-reactivity in rodent, dog or nonhuman primate matrices has to be confirmed rather than assumed. Assays are usually validated fit-for-purpose, with the level of rigor matched to how the data will be used, from exploratory readouts to go/no-go endpoints.
If a biomarker is meant to carry forward into clinical trials, choose the assay and platform with that path in mind so preclinical and clinical results can be compared directly.
Biomarker CROs for Preclinical Studies
Showing 7 CROs. Order rotates daily so no lab is permanently listed first.
InnoStar
Shanghai-based nonclinical CRO with GLP safety evaluation, pharmacology, DMPK, bioanalysis and biomarker services for small molecules, biologics and cell and gene therapies, operating several sites in China.
KCAS Bio
Bioanalytical and biomarker CRO supporting preclinical and clinical programs with LC-MS/MS, ligand binding, flow cytometry and cell and gene therapy assays, with sites in the US and France.
Biomere
Biomere (a JOINN company) is a preclinical CRO based in Worcester, MA. Services include non-GLP PK/PD, discovery toxicology, surgical services, disease models, and laboratory sciences. Surgical services include…
XenTech
French translational oncology CRO built around patient-derived xenograft models, with drug response and biomarker discovery services.
Bioneer
Danish non-profit research CRO offering customised cell models, assays and translational research services.
BioAgilytix
Large molecule bioanalytical laboratory providing GLP and GCLP pharmacokinetic, immunogenicity, biomarker and cell-based assays, with labs in the US and Europe.
Questions to ask when choosing a Biomarker Analysis CRO
- Has this assay been qualified in our species and matrix, or only in human samples?
- What level of fit-for-purpose validation do you propose, and what acceptance criteria will you use?
- Can biomarker samples be collected from the same animals as PK and efficacy endpoints?
- How are samples collected, processed and stored to protect unstable analytes?
- Could the same assay platform be used later in our clinical program?
Biomarker Analysis CRO FAQs
What does a biomarker CRO do?
A biomarker CRO develops, validates and runs assays that measure biological markers of drug activity, disease or safety, such as target engagement markers, cytokines, neurofilament light, or cell populations by flow cytometry. Preclinical biomarkers connect efficacy and toxicology studies to endpoints that can be measured in the clinic.
How are preclinical biomarker assays validated?
Biomarker assays are usually validated as fit for purpose: the depth of validation matches how the data will be used. An exploratory marker may need only precision and range checks, while a biomarker that supports dose selection or a safety decision needs fuller validation of accuracy, selectivity and stability in the relevant species matrix. Agree the context of use with the lab before work starts.