Inside preclinical NAMs innovation: A Q&A with Labcorp experts Darren Kidd and Jessica Palmer on devTOX quickPredict™

In this edition of our R&D Insight Series, we spoke with Darren Kidd, a senior scientific leader in Labcorp’s in vitro Toxicology group and Jessica Palmer, the developer of the devTOX quickPredict™ assay, to discuss how devTOX quickPredict™ is reshaping early-stage decision‑making, the growing role of NAMs in developmental toxicity assessment, and how integrated DART strategies are helping sponsors move faster with greater scientific confidence. 

What makes developmental toxicity uniquely challenging for early-stage teams? 

Darren Kidd: Developmental toxicity is inherently complex because maternal physiology, placental biology, and embryofetal development interact in ways that traditional early screens can’t easily capture. Historically, teams relied on in vivo DART studies, but those occur much later, require substantial test material, and often identify risks at a stage when making major changes is costly and slow. 

In early discovery, the questions are more precise: Which candidates are viable enough to advance? How do we avoid unexpected late‑stage findings? And how do we generate human-relevant insight when test material is scarce? 

That’s why teams increasingly need modern in vitro NAM tools that provide directional clarity without slowing down medicinal‑chemistry cycles. 

devTOX quickPredict is positioned as a first‑in‑class NAM for developmental toxicity. How does the assay work, and what sets it apart scientifically? 

Jessica Palmer: devTOX quickPredict™ uses human-induced pluripotent stem cells to detect early developmental toxicity through changes in the ratio between ornithine and cystine (O/C ratio), two validated metabolomic biomarkers. This biomarker ratio responds to pathway disruptions independently of cytotoxicity, giving us a mechanistic and quantitative view of developmental hazard. Importantly, the assay’s results have demonstrated that the concentration where changes in the O/C ratio are observed can be related to the expected human exposures, allowing exposure-based interpretation of the data. Several attributes make the assay unique: 

• Human‑relevant biology rather than cross‑species extrapolation
• Strong predictive performance (~85–90%) against known human developmental toxicants
• Ability to distinguish developmental effects from general cytotoxicity
• Rapid turnaround measured in weeks
• Minimal test material requirement (from as little as15 mg), ideal for early-stage programs 

devTOX quickPredict™ is the only assay of its kind with more than a decade of use, a strong publication history, and an FDA-approved Qualification Plan under their Biomarker Qualification Program with a defined Context of Use statement, which are critical steps for the regulatory application of NAMs.

How do biopharma teams typically integrate devTOX quickPredict™ into their decision-making workflows? 

Jessica Palmer: Teams use devTOX quickPredict™ at multiple stages of compound safety profiling, including during hit-to-lead and lead optimization to rapidly screen large numbers of compounds; during candidate selection to derisk final choices before IND-enabling planning; and during issue resolution, when unexpected findings require mechanistic clarity. Because the assay delivers quantitative developmental toxicity thresholds, teams can prioritize analogs, optimize chemical series, reduce animal use, and prevent costly late-stage failures. Importantly, devTOX quickPredict™ integrates directly into Labcorp’s tiered DART workflow, feeding seamlessly into SEG I/II/III and NHP ePPND studies when escalation is needed. 

Some sponsors ask whether NAM assays are accepted by regulators. How do you respond to that?

Darren Kidd: devTOX quickPredict™ has an FDA-agreed Context of Use statement and complies with the ICH S5(R3) definition of a “qualified alternative assay.” It is also recognized by the EPA and has supported multiple NTP and Tox21 initiatives, reinforcing its credibility as a modern NAM tool. For biopharma teams, the key message is that while this assay cannot replace in vivo DART in most cases, it significantly improves early prioritization and can be used as part of a weight of evidence approach to replace in vivo testing in specific scenarios defined in the ICH S5(r3) guidelines. With regulators increasingly encouraging mechanistic, human-relevant data earlier in development, devTOX quickPredict™ provides an important foundation that helps sponsors generate meaningful insights and build more robust, future ready nonclinical strategies. 

Many early-stage programs struggle with limited test material. How does devTOX quickPredict™ address this constraint?

Jessica Palmer: This is one of the assay’s biggest advantages. devTOX quickPredict™ can be performed on compound amounts from as little as 15 mg of material, making it ideal for programs where synthesis capacity, modality complexity, or cost limit availability. That includes RNA therapeutics, peptides, monoclonal antibodies, gene‑ and cell‑therapy constructs, and high‑value impurity or variant assessments. It allows teams to generate meaningful hazard insight long before in vivo work becomes feasible. 

How does Labcorp support interpretation and integration of devTOX quickPredict™ results? 

Darren Kidd: Interpreting metabolomic biomarkers requires deep expertise—not only in stem‑cell biology but in DART mechanisms, translational toxicology, and assay‑specific nuances. Our scientists closely collaborate with sponsors to contextualize changes in the O/C ratio, determine developmental toxicity thresholds, define non‑cytotoxic windows, and decide whether and when escalation to in vivo studies is appropriate. This expertise in interpretation strengthens decision‑making and integrates assay results more seamlessly into broader DART strategies. 

What advice would you give biopharma teams as they plan their DART strategies for 2026 and beyond?

Darren Kidd: Build a tiered approach from the start. Program success improves when teams: 

• Screen early with human-relevant NAM tools
• Use exposure-threshold data to guide medicinal chemistry
• Escalate only when signals justify it
• Maintain continuity across partners

Because Labcorp provides devTOX quickPredict™ SEG studies NHP ePPND in one ecosystem, sponsors can avoid the fragmentation that often delays development. 

Jessica Palmer: It is important to work closely with the regulators and open the discussion early regarding the use of NAMs like devTOX quickPredict™ for DART. This will be important for helping everyone in the process understand how these assays can be applied in a regulatory setting, and everyone will be better informed about what is expected from the regulators regarding the assay’s use.