Albuminomics Patent Portfolio

Three granted/filed patents from INSERM / CHU Limoges / Université de Limoges, covering a complete “3-level” functional and structural diagnostic platform based on HSA post-translational modifications.

Inventors on all patents: Souleiman El Balkhi (lead), Franck Saint-Marcoux, Jean-Baptiste Woillard.

The 3-Level Platform

All three levels operate on a single blood draw and analyze HSA from complementary angles:

LevelPatentTechnologyWhat it measures
1US20220018852ICP-MS (SEB Test)Functional binding capacity of albumin
2WO2024074685Top-Down LC-MS isoform profilingStructural etiology signature (ALD vs MASH)
3WO2025099157Top-Down LC-MS + myoglobin ISAbsolute quantification of isoforms

Level 1 — Functional (SEB Test)

US20220018852 / SEB test

Measures the effective binding capacity of albumin by spiking serum with 5 metal/organic ligands (Cu, Co, Au, Cd, T4/dansylsarcosine) and quantifying the free (unbound) fraction via ICP-MS. A high free fraction = albumin is structurally damaged and cannot bind toxins. Detects liver dysfunction earlier than ALT/AST.

Level 2 — Structural / Etiological (Isoform Profiling)

WO2024074685

Identifies and quantifies up to 14 HSA isoforms by Top-Down LC-MS. Key finding: disease-specific PTM signatures:

  • ALD signature: elevated HSA-DA (N-terminal dipeptide truncation, −186 Da)
  • MASH/NASH signature: elevated HSA-SGGS (S-glutathionylation) + HSA-2Glyc (double glycation)
  • Use case: liquid biopsy for liver disease etiology without biopsy; clinical trial cohort purity screening (exclude hidden alcohol consumers from MASH trials)

Level 3 — Absolute Quantification

WO2025099157

Solves the longstanding problem of mass accuracy and absolute quantification in Top-Down proteomics. Myoglobin co-injected as internal standard enables:

  • Real-time mass recalibration to <3 ppm error
  • Absolute quantification without isotope labeling
  • Extended to hemoglobin → HbA1c precision measurement resistant to hemoglobin variants

IP Status

DocumentTypeFiledPublishedApplicants
WO 2020/104458 A1PCT (members: US 2022/0018852 A1; EP 3 884 280 B1 granted; ES 2 971 966 T3)PCT Nov 20192020INSERM, CHU Limoges, Univ. Limoges
WO 2024/074685 A1PCT Application~20232024INSERM, CHU Limoges, Univ. Limoges
WO 2025/099157 A1PCT Application~20242025INSERM, CHU Limoges, Univ. Limoges

Strategic Value

The portfolio positions the group at the intersection of three high-growth markets:

  1. Hepatic diagnostics — non-invasive alternatives to liver biopsy (FIB-4 + FibroScan complement, not compete)
  2. Theranostics for albumin therapy — companion diagnostic for Grifols/CSL Behring albumin infusion (ANSWER trial, ATTIRE trial)
  3. Clinical trial services — cohort purity tool for MASH pharma trials (Resmetirom, etc.)

See technology-transfer for full commercialization strategy and albuminomics-partnerships for specific partner proposals.

Publication Basis

  • el-balkhi-2024-seb — SEB Test (Level 1): rat early-detection model + human pilot (45 cirrhotic vs 45 controls, Sci Rep 2024); large multicentric validation ongoing via MALAHBAR (560 pts / 8 CHUs, readout ~2027)
  • lakis-2024 — Absolute quantification method (Level 3 basis)
  • el-balkhi-2025 — ALBOM study clinical validation (Level 2) — published, Sci Rep 2026, DOI 10.1038/s41598-026-57614-y (Open Access)