Spokane, WA – 08/15/2025 – Precision Quantomics has announced two major advancements in its mission to modernize drug development: the launch of a next-generation LC-MS/MS–based assay kit—MSQ-DILI—and the expansion of its Quantitative Proteomics Services to support the qualification of emerging human drug testing platforms, including organoids and micro-physiological systems (MPS).
The MSQ-DILI kit is designed to quantify protein biomarkers associated with drug-induced liver injury, in in vivo and in vitro systems. These kits are optimized for human-relevant models such as primary hepatocyte cultures, 3D organoids, and MPS platforms. Each kit includes finely calibrated stable-isotope–labeled peptides, validation and quality controls, robust protocols, and calibration data to support reproducibility, allowing seamless integration into preclinical workflows for enhanced decision-making.
Separately, PQ has expanded its CRO-style proteomics services to help drug developers qualify the sourcing, biological fidelity, and consistency of in vitro models used in NAMs. This includes rigorous quantitative profiling of model systems and comparison to human physiological baselines using popDTPdb, PQ’s proprietary population-informed proteomics database.
“Toxicity prediction and model qualification represent two critical bottlenecks in replacing animal testing,” said Chandima Bandara, CEO of Precision Quantomics. “With our new kit, researchers can detect early signals of liver injury in models that better reflect human biology. In parallel, our expanded services allow developers to benchmark their in vitro systems against real-world human quantitative proteomic data, increasing confidence in both the performance and sourcing of their models.”
By supporting both quantitative toxicology and model validation, Precision Quantomics enables a more confident transition to New Approach Methodologies (NAMs) and helps advance safer, more human-relevant drug development.
Following recent guidance from the National Institutes of Health (NIH), which announced it will no longer fund research proposals that rely exclusively on animal models, tools that support New Approach Methodologies (NAMs) have gained renewed importance. The NIH’s establishment of the Office of Research Innovation, Validation, and Application (ORIVA) reflects a broader shift toward human-relevant systems and quantitative validation approaches. In alignment with these goals, Precision Quantomics has launched the MSQ-DILI Kit for improved detection of drug-induced toxicity and expanded its proteomics services to help qualify NAMs by providing functional insights through quantitative proteomics and benchmarking against population-level human protein expression data from popDTPdb.
The MSQ-DILI Kit is part of a broader suite of LC-MS/MS–based proteomics kits offered by Precision Quantomics, who also offers a broad range of custom kits, services, and consultation for use in early drug discovery. This includes solutions for measuring cytochrome P450 enzymes, drug transporters, and glucuronosyltransferases to support drug metabolism, disposition, and safety assessments in human-based models. All kits are validated for use in in vitro systems and provide reference-calibrated, quantitative data compatible with PBPK modeling and IVIVE workflows.
Scientific and Regulatory Alignment
“While NAMs represent a promising shift toward more ethical and human-relevant tools in drug development, their widespread adoption hinges on comprehensive, quantitative characterization,” said Dr. Bhagwat Prasad, Chief Scientific Officer at Precision Quantomics. “Without robust quantitative validation, NAMs risk falling short in regulatory settings and failing to replace traditional animal models in a meaningful way. Drug development continues to face major challenges, including high failure rates, unanticipated human toxicity, and limited translational value of animal models. To address these, NAMs must not only be innovative, but also well-defined, reproducible, and characterized against physiologically relevant data.”
The MSQ kits from Precision Quantomics provide standardized, mass spectrometry-based tools to quantify drug toxicity and ADME-related protein biomarkers in human-derived in vitro systems. In parallel, the popDTPdb resource enables researchers to benchmark in vitro data against population-scale protein expression across human tissues.
“This dual approach, i.e., quantifying NAMs systems and comparing them to real-world human biology, not only enhances IVIVE and PBPK modeling, but also builds the foundation for regulatory trust and scientific credibility. Ultimately, our goal is to ensure that NAMs live up to their promise by making them quantitatively rigorous and biologically relevant,” Dr. Prasad added.
Precision Quantomics’ MSQ kits are designed for use in regulatory submissions, IVIVE studies, and translational modeling projects involving emerging in vitro systems.
The MSQ-DILI Kit is now available for order, along with expanded proteomics services to support NAM qualification. For product details, pricing, or consultation, visit https://precisionquantomics.com or contact the team at contact@precisionquantomics.com.
⸻ About Precision Quantomics Inc.
Founded in 2020 with the vision of accelerating the drug development process, Precision Quantomics Inc. specializes in the integration of quantitative proteomics into pharmacokinetic modeling to address critical gaps in drug safety and efficacy. The company’s innovative approach leverages cutting-edge technology to create tools and resources that enhance the predictability and inclusivity of drug development processes. We aim to update the current approach to toxicology testing in drug development, one collaboration at a time. For more information, visit www.precisionquantomics.com.
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