Patent & Pipeline
The DermaSafe SCT™ is built on a patented enzyme-activity reduction platform with broad applicability across nine human tissue types, forming the foundation for a new generation of nonanimal toxicology.
What the Patent Covers
U.S. Patent US12559784B2, granted February 24, 2026 to Lebrun Labs LLC, covers a cell-free, reagent-based assay in which a test material is exposed to a defined enzyme or enzyme mixture. The degree to which the test material reduces enzymatic activity predicts the extent and classification of toxicity to living tissue.
Because the assay uses no animal tissues, cells, or cell cultures, it is classified as an in chemico method: the most shelf-stable and field-deployable category of nonanimal test under OECD guidelines.
Core Method Claims
- 1Applying a test substance to a predefined enzyme or enzyme mixture to effect an in chemico reaction
- 2Measuring any reduction in enzymatic activity on a predefined substrate
- 3Comparing the measured reduction to a control or previously established activity value
- 4Predicting the extent or classification of living tissue toxicity based on the measured reduction
Broad Tissue Applicability: Beyond Dermal Testing
The WIPO abstract and patent specification make clear that the enzyme-activity reduction platform is not limited to skin. The inventors disclose applicability to the full spectrum of human tissue toxicity assessment.
Skin (Dermal)
DermaSafe SCT™
Resolves GHS Category 1 into subcategories 1A, 1B, and 1C. Assigns DOT packing groups. Key differentiator vs. RhE models.
OECD TG 431, DOT 49 CFR Part 173
Ocular (Eye)
IVD EIT™ complement
Extends to ocular toxicity via lysozyme, lactate dehydrogenase, and corneal esterases. Shelf-stable alternative to RhCE models.
OECD TG 492, OECD TG 496
Pulmonary (Lung)
In development
Surfactant-associated proteins, proteases, and oxidoreductases modeled for aerosols, vapors, and respirable particulates.
OECD TG 403, REACH inhalation
Hepatic (Liver)
In development
ALT, AST, and CYP450 isoforms configured for rapid, cell-free hepatotoxic potential screening.
ICH S2(R1), FDA DILI guidance
Neurological
In development
AChE inhibition as validated endpoint for cholinergic toxicity. Applicable to organophosphate and carbamate pesticides.
OECD TG 424, EPA neurotoxicity
Developmental / Repro.
In development
RALDH, DHFR, aromatase (CYP19A1) and steroidogenic enzymes for teratogenicity and endocrine disruption screening.
OECD TG 414, REACH Repr.
Acute Systemic
In development
Multi-enzyme panels spanning hepatic, renal, cardiac, and hematological markers for broad-spectrum tier-1 screening.
OECD TG 129, GHS Cat. 1–5
Renal (Kidney)
In development
NAG, GGT, alkaline phosphatase, and KIM-1 associated enzymes for nephrotoxicity from heavy metals and pharmaceuticals.
OECD TG 407/408, ICH S7A
Cardiac
In development
CK-MB and cardiac troponin-associated enzymatic pathways for rapid, cell-free cardiotoxic potential screening.
ICH S7B, FDA cardiac safety
High-Throughput Workflow: From Chemical to Report in 6 Hours
Using standard 96-well or 384-well microplate formats, automated liquid handling, and a high-throughput spectrophotometric plate reader, a single operator can test up to 30 different chemicals simultaneously across the full human tissue panel, delivering a complete multi-tissue toxicity profile within 6 hours from sample receipt to final report.
Sample Intake
~30 min
Up to 30 test materials received and logged. Each prepared at a defined concentration range in aqueous buffer.
Automated Plate Setup
~45 min
Automated liquid handling robot dispenses test materials, enzyme reagents, and substrate solutions into 96-well or 384-well microplates. No manual pipetting required.
Incubation
1–4 hrs
Plates incubated at 37°C. Test chemical reacts with enzyme reagent. Greater toxicity produces greater reduction in enzymatic activity.
Plate Reader Measurement
~2 min
High-throughput spectrophotometric plate reader measures absorbance across all wells simultaneously at substrate-specific wavelength (405–450 nm).
Microplate Format
96 or 384-well
384-well format enables all 30 test chemicals in triplicate across 9 tissue enzyme panels on a single plate. Low reaction volumes (10–50 µL) minimize reagent use.
Report Generation
~30 min
Percent enzyme activity calculated per chemical × tissue combination. Results expressed as quantitative toxicity score and GHS/regulatory classification.
Total elapsed time
~30 min
Sample intake
~45 min
Plate setup
1–4 hrs
Incubation
~30 min
Read + analysis
~30 min
Report
Total: ≤ 6 hours from sample receipt to final report · Up to 30 chemicals tested simultaneously
Example: Full Human Tissue Panel Report Output
The following illustrates the multi-tissue toxicity profile generated for a strong industrial oxidizer (sodium hypochlorite, 10% w/v) tested across all nine tissue enzyme panels simultaneously.
ICSC REPORT OUTPUT — LEBRUN LABS LLC
SODIUM HYPOCHLORITE — 10% w/v · CASRN: 7681-52-9
| Tissue Panel | Enzyme Marker | % Act. Remaining | Classification |
|---|---|---|---|
| Skin (Dermal) | Biomimetic skin enzyme substrate | 4.2% | GHS Cat. 1A — Corrosive (DOT PG I) |
| Ocular (Eye) | Corneal esterase / lysozyme | 7.1% | GHS Cat. 1 — Serious Eye Damage |
| Pulmonary (Lung) | Surfactant protein / lung esterase | 11.3% | Acute Inhalation Hazard — Cat. 1 |
| Hepatic (Liver) | ALT / CYP3A4 activity | 38.4% | Moderate hepatotoxic potential |
| Neurological | Acetylcholinesterase (AChE) | 82.1% | Not classified — low neurotoxic potential |
| Developmental / Repro. | RALDH / aromatase (CYP19A1) | 44.0% | Potential endocrine disruptor — flag |
| Acute Systemic | Multi-organ enzyme panel | 9.0% | GHS Acute Tox. Cat. 1 — Oral/Dermal |
| Renal (Kidney) | NAG / GGT activity | 51.2% | Moderate nephrotoxic potential |
| Cardiac | CK-MB / LDH-1 isoforms | 76.3% | Not classified — low cardiotoxic potential |
Applications of the Full Human Tissue Panel
Drug Development
- Screen 30 structural analogs simultaneously to identify the safest multi-tissue candidate
- Hepatic enzyme panel (ALT, CYP3A4) flags DILI potential before IND-enabling studies
- CK-MB and LDH-1 data provide early cardiotoxicity signal complementing hERG assays
- Evaluate excipients, solvents, and delivery vehicles across all tissue types in one run
Research Toxicology
- Map toxicological SAR across nine tissue types for a chemical series
- Test complex mixtures for multi-tissue hazard in a single run
- Generate mechanism-of-action hypotheses from tissue-specific enzyme inhibition patterns
- Compatible with HTS workflows for large compound library screening
Regulatory Toxicology
- Multi-tissue results support GHS classification across multiple endpoints from one run
- Supports REACH multi-endpoint data requirements as alternative to in vivo studies
- Quantitative, reproducible data suitable for OECD test guideline validation studies
- Dermal and systemic data support DOT packing group assignment
Interested in the platform behind DermaSafe?
The enzyme-activity reduction platform is owned and developed by Lebrun Labs LLC — the assignee of U.S. Patent US12559784B2 and recipient of NIH/NIEHS Award R44 ES036065. Lebrun Labs is the commercial and scientific home of this technology, with a roadmap spanning nine human tissue types and high-throughput multi-tissue panels.
If you are interested in licensing, partnership, contract research, or investment opportunities related to this platform, visit Lebrun Labs directly.
Lebrun Labs LLC
NIH/NIEHS Support
Research reported in this publication was supported by the National Institute of Environmental Health Sciences of the National Institutes of Health under Award Number R44 ES036065 (2024–2027), awarded to develop a new nonanimal, high-throughput, field test to identify dermal corrosives — the first commercial application of this broadly applicable platform. Inventors: Stewart Lebrun PhD and Linda Nguyen. Assignee: Lebrun Labs LLC.