IQVIA Laboratories Protein Biomarkers —previously known as Rules-Based Medicine —brings more than 25 years of expertise in custom assay development. Our proven processes offer several strategic and scientific advantages over off-the-shelf commercial assay kits, particularly in early-phase or biomarker-driven studies.
We currently offer custom assay development on the following platforms:
In addition, Olink assays can be customized through the Olink Flex and Focus programs.
Feasibility to determine if the assay will meet specifications
Combinations of antibodies are tested to find the pair with the best sensitivity, specificity and dynamic range
Assays are multiplexed according to the concentration of the analyte in the matrix of interest
Elimination of non-specific interfering signal with proprietary blockers
Three-level controls that span the range of the standard curve
Guided by the Clinical Laboratory Standard Institute (CLSI)
Our biomarker validation process includes 6 steps to ensure optimal results:
Feasibility to determine if the assay will meet specifications
Combinations of antibodies are tested to find the pair with the best sensitivity, specificity and dynamic range
Assays are multiplexed according to the concentration of the analyte in the matrix of interest.
Elimination of non-specific interfering signal with proprietary blockers
Three-level controls that span the range of the standard curve
Guided by the Clinical Laboratory Standard Institute (CLSI)
Tap each area to view examples across improved sensitivity, greater control over assay lifecycle and supply and more
Custom development allows assay performance to be optimized for a customer’s need, not just analytical convenience. Our lower limits of detection are particularly useful in capturing early pharmacodynamic changes for earlier signal detection in Phase I/II, increased clarity in understanding dose–response relationships, and reduced false positives/negatives that can complicate interpretation.
Custom assays can be explicitly designed to support pharmacodynamic endpoints, patient stratification strategies, and identifying complementary pathways. Commercial kits may only measure a “related” marker, not the one that best reflects drug activity. Commercial kits may also have limited validation in the specific indication or patient population.
With custom assays, sponsors gain control and continuity across development phases. IQVIA Laboratories Protein Biomarkers has established processes to ensure we have sufficient quantities of critical reagents and decades of expertise in lot-to-lot validation. In contrast, commercial kits may change antibodies, calibrators, or protocols without notice, which can make it challenging when supporting longitudinal studies.
Novel targets require custom assay development to ensure that the assay is measuring the specific biomarker of interest what matters and not a “related” biomarker.
Custom assay development timelines vary based on need, but our approach optimizes the process to align with your study needs. We deliver long-term efficiency by having fewer failed studies due to inadequate biomarker sensitivity, reduced need for repeat testing. By enabling “go/no-go” decisions earlier in the development process, we help customers move forward with confidence.
IQVIA Laboratories Protein Biomarkers utilizes a proprietary RF blocker to improve the accuracy, reliability, and clinical relevance of multiplex immunoassay data by minimizing RF‑driven interference and false positives. This capability is particularly critical for studies involving autoimmune, elderly, or general clinical populations where RF levels are unknown and cannot be controlled in advance.
| PART # | STIMULUS | DESCRIPTION | TYPE |
|---|---|---|---|
| 782-001277 | Interferon beta (IFN-beta) | Type I interferon, modulator of for example T lymphocyte responses | Cytokine |
| 782-001278 | Interleukin-1beta (IL-1beta) + tumor necrosis factor- alpha (TNF-alpha) | 2 synergistically acting pro-inflammatory cytokines (weak to modest immune cell activation) | Cytokine |
| 782-001295 | TNF-alpha | Pro-inflammatory cytokine; weak activator of mediator synthesis when used alone | Cytokine |
| 782-001086 | Null | Pure (proprietary) TruCulture media without stimulants | Negative Control |
| 782-001291 | NegCo | TruCulture media without stimulants, specially formulated for premium and custom tubes | Negative Control including custom excipients |
| 782-001272 | Adenosine Triphosphate (ATP) + Lipopolysaccharide (LPS-EB) | ATP modulates via purinergic receptors (such as P2X7) LPS-induced activation of cells of the innate part of the immune system | NLRP3 Inflammasome / TLR4 Ligand |
| 782-001273 | Lauroyl-γ-D-glutamyl-meso-diaminopimelic acid (C12-iE-DAP) | Dipeptide representing bacterial peptido-glycan, activator of NOD1 (intracellular pattern recognition receptor) | NOD Ligand |
| 782-001259 | Zymosan | ß-glucan particles (fractions of yeast cell walls); triggers phagocytosis via TLR2, Dectin, and CD11/18 | Phagocyte activator |
| 782-001275 | HKEB | Heat killed preparation of the gram negative bacterium, E. Coli O111:B4. Triggers phagocytosis via TLR2, TLR4, and various others | Phagocyte activator |
| 782-001125 | anti-CD3 + anti-CD28 | Two antibodies triggering T-cell activation via the signaling unit of the T-cell receptor complex (CD3) + co-activation (intensifying T-cell responses, adding activities of Th2 and Treg) via CD28 | T-Cell activation |
| 782-001202 | anti-CD3 | T-cell activation via the signaling unit of the T-cell receptor complex (CD3) | T-Cell activation |
| 782-001416 | TStim | TCR-MHC cross-linking Mabs plus co-stim | T-Cell activation |
| 782-001274 | Fibroblast-Stimulating Lipopeptide (FSL-1) |
Synthetic analogue of microbial lipoprotein; agonist of TLR2/TLR6 |
TLR2 Ligand |
| 782-001282 | Polyinosinic : polycytidylic acid (Poly I:C) | Analogue of double-stranded RNA, mimics the presence of viral infection. Activator of TLR3 | TLR3 Ligand |
| 782-001087 | Lipopolysaccharide (LPS) | Bacterial endotoxin (E.coli, O55:B5) that elicits a strong innate immune response | TLR4 Ligand |
| 782-001261 | LPS-EB | Bacterial endotoxin (E.coli, O111:B4) that elicits a strong innate immune response | TLR4 Ligand |
| 782-001455 | LPS+TStim | Bacterial edotoxin (E.coli, O55:B5) that elicits a strong innate response in addition to a T cell response by crosslinking the T cell receptor and MHC on monocytes/macrophages | TLR4 Ligand + T cell receptor ligand |
| 782-001269 | Gardiquimod | Synthetic agonist of TLR7 (responding to single-stranded RNA, for example) | TLR7 Ligand |
| 782-001264 | Resiquimod (R848) | Synthetic agonist of TLR7 and TLR8 (both responding to single-stranded RNA) | TLR7/8 Ligand |
