VLVbio
VLVbio is a Swedish biotechnology company that develops, manufactures, and sells CE-IVD marked keratin-18 ELISA biomarker kits used by hepatology clinics, pharmaceutical companies in MASLD/MASH clinical trials, and academic researchers to non-invasively detect and monitor epithelial cell death.
- Company typePrivate
- Founded2013
- HeadquartersNacka, Sweden
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What VLVbio does
VLVbio AB is a Swedish biotechnology company founded in 2013 in Sundbyberg (later relocating to Nacka, Stockholm) that develops, manufactures, and sells in vitro diagnostic ELISA kits based on proprietary keratin-18 (K18) biomarker technology. The company took over the PEVIVA product line originally invented at the Karolinska Institute in 1996, and operates a portfolio of CE-IVD marked assays — M30 Apoptosense ELISA (caspase-cleaved K18 / apoptosis), M65 ELISA and M65 EpiDeath ELISA (total soluble K18 / total cell death), M30 CytoDeath ELISA (cell culture), and M65 EpiRat ELISA (pre-clinical / toxicology) — used to non-invasively detect and monitor epithelial cell death in liver disease and oncology applications.
The underlying technology rests on the proprietary M30, M5, and M6 monoclonal antibodies, which enable quantification of hepatocyte apoptosis and total epithelial cell death with documented meta-analytic performance (pooled AUROC ~0.82, sensitivity 78%, specificity 86% for MASH detection). VLVbio serves three primary end markets: hepatology and gastroenterology clinics (for MASH/MASLD diagnosis and treatment monitoring), pharmaceutical and biotech companies (as screening tools and endpoint biomarkers in 60+ active MASLD/MASH clinical trials), and academic / pre-clinical research institutions. The M30 Apoptosense and M65 assays are CE marked as IVDs in Europe, ANVISA-accepted in Brazil, and — via the IMMUNIS Cytokeratin 18F EIA developed with the Institute of Immunology Japan — PMDA-approved and reimbursed under Japan's national health insurance since 2024; an FDA 510(k) de novo trial has been enrolling since 2019.
VLVbio operates a 100% distributor-based go-to-market model, with 20+ regional partners (including DiaPharma Group in the US/Canada, TECOmedical across Europe, FUJIFILM Wako in China/Hong Kong, Funakoshi in Japan, and XboXLab in the Nordics) covering 60+ countries. Revenue is generated through one-time product sales of ELISA kits with quote-based pricing. The company maintains an ISO 13485:2016 quality system certified by BSI, a staff of approximately 7 employees, and strategic collaborations including the LITMUS and GripOnMASH EU-funded consortia for biomarker validation. Funding history is undisclosed and the company appears to be founder/privately held with no institutional backers identified.
VLVbio firmographics
Firmographics- Name
- VLVbio
- Legal name
- VLVbio AB
- Website
- https://vlvbio.com
- Company type
- Private
- Founded year
- 2013
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- VLVbio is a Swedish biotechnology company that develops, manufactures, and sells CE-IVD marked keratin-18 ELISA biomarker kits used by hepatology clinics, pharmaceutical companies in MASLD/MASH clinical trials, and academic researchers to non-invasively detect and monitor epithelial cell death.
- Ownership category
- akta.pro rank
VLVbio industry classification
Industry- Product category
- In Vitro Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)
- akta.pro secondary industry
- Proteomics & Biomarker Analytical Testing (HLAGADAG)
Keywords
Where VLVbio is headquartered
LocationHeadquarters
- HQ city
- Nacka
- HQ country
- Sweden
- HQ region
- Europe
Offices2 records
Markets served
VLVbio business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Supply Chain, Infrastructure
Revenue model
- ELISA Kit Product Sales: Sale of diagnostic ELISA kits for detecting cell death biomarkers. Products include M30 Apoptosense, M65, M65 EpiDeath, M65 EpiRat, and M30 CytoDeath assays sold globally through distributor network.
- Clinical Research Products: Supply of K18 assays for pharmaceutical clinical trials in MASLD/MASH drug development, used as screening tools and endpoint measurements.
Go-to-market motion2 records
Distribution channels1 record
Marketing channels8 records
VLVbio product offering
Product offeringCore offering
VLVbio manufactures, R&Ds, and sells the PEVIVA product line of ELISA-based in vitro diagnostic kits that detect keratin-18 (K18) biomarkers of epithelial cell death. The kits (M30 Apoptosense®, M65®, M65 EpiDeath®, M30 CytoDeath™, M65 EpiRat™) quantify hepatocyte apoptosis and total cell death for clinical diagnosis of MASH/MASLD and for pre-clinical and clinical research in hepatology and oncology.
Product overview
VLVbio offers a portfolio of ELISA-based biomarker assays for measuring epithelial cell death. The core products are the M30 Apoptosense® ELISA and M30 CytoDeath™ ELISA (measuring apoptosis via caspase-cleaved keratin 18) and the M65® ELISA, M65 EpiDeath® ELISA, and M65 EpiRat™ ELISA (measuring total cell death including both apoptosis and necrosis). The M30 Apoptosense® ELISA is CE-IVD marked for clinical diagnostic use in liver diseases including MASH and alcohol-associated liver disease. The products are used globally by hospitals, academia, and industry for hepatology research, oncology drug development, and toxicology applications.
Differentiator
Problem solved
Functional benefit
Brands
- PEVIVA Keratin 18 Biomarkers: The original product line of ELISA kits (M30 Apoptosense®, M65®, M65 EpiDeath®, M30 CytoDeath™, M65 EpiRat™) for measuring epithelial cell death in liver disease and oncology.
Products and services
- M30 Apoptosense® ELISA ELISA assay that measures caspase-cleaved keratin 18 (ccK18) in human serum and cell culture supernatants, reflecting the amount of apoptosis. Uses the unique M30 antibody that recognizes a neo-epitope formed after caspase cleavage. CE marked as an IVD medical device for clinical diagnostic use in liver disease.
- M65® ELISA ELISA assay that measures total cell death (apoptosis and necrosis) by quantifying levels of total soluble keratin 18 (K18) released from dying epithelial cells. Based on M5 and M6 antibodies. CE marked as an IVD medical device for clinical diagnostic use.
- M65 EpiDeath® ELISA ELISA assay measuring the concentration of total soluble keratin 18 (K18) in human plasma, serum, and cell culture supernatants. K18 levels reflect total cell death from apoptosis or necrosis of epithelial cells. CE marked for IVD use.
- M30 CytoDeath™ ELISA ELISA assay for measuring human cell death by apoptosis in cell cultures, multicellular spheroids, and organ culture systems. Developed for cell culture applications with dynamic range and sensitivity suitable for in vitro work, serving as a drug screening tool.
- M65 EpiRat™ ELISA Rat-specific ELISA assay based on M5 and M6 antibodies that measures total cell death (apoptosis and necrosis) in K18 positive cells by quantifying K18 in rat serum and plasma samples. Used in toxicology and pre-clinical drug development studies.
Quantifiable outcome
- Pooled AUROC of 0.82, 78% sensitivity, 86% specificity for MASH detection
- +3 more outcomes
Companies that use VLVbio
Customer profileNamed customers3 records
Segments4 records
Ideal customer profiles4 records
VLVbio technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
VLVbio partnerships and signals
Strategic signalPartnerships
15 partnerships are on record, tiered core, major and minor.
- Institute of Immunology (Japan)coreLong-standing collaboration with Japan's Institute of Immunology resulting in the IMMUNIS Cytokeratin 18F EIA launch. The product gained PMDA approval as IVD for NASH diagnosis in Japan and was included in Japan's national health insurance system for broad accessibility.
- LITMUS ConsortiumcoreEU-funded project to evaluate and find the best performing NAFLD biomarkers. VLVbio's M30 Apoptosense was included in the LITMUS project starting 2018 for biomarker validation.
- GripOnMASH ConsortiumcoreCollaborative consortium with leading clinical academic centers, regulatory bodies, and industry partners to advance biomarker development for MASLD/MASH diagnosis and monitoring.
- DiaPharma Group (US/Canada)coreExclusive distributor for VLVbio products in the United States and Canada, serving pharmaceutical companies, hospitals, and research institutions.
- TECOmedical Group (Europe)coreTECOmedical AG (Switzerland headquarters) with offices in Germany, France, and Benelux serves as distributor across multiple European countries.
- FUJIFILM Wako (China/Hong Kong)coreDistributor for PEVIVA products in mainland China and Hong Kong through FUJIFILM Wako Trading Corporation.
- XboXLab (Nordics)corePartnership established 2023 for distribution of VLVbio kits in Sweden, Denmark, Finland, and Norway.
- Funakoshi (Japan)majorDistributor for VLVbio products in Japan market.
- BioScientific (Australia/New Zealand)majorDistributor for VLVbio products in Australia and New Zealand.
- Precision Technologies (Southeast Asia)majorDistributor covering Singapore, Malaysia, and Indonesia.
- GastroLab IndiamajorDistributor for VLVbio products in India.
- Exomedica (Baltics)minorDistributor covering Estonia, Latvia, and Lithuania.
- Pantec (Italy)minorDistributor for VLVbio products in Italy.
- Bioaxxess (UK/Ireland)majorDistributor for VLVbio products in United Kingdom and Ireland.
- VIDIA (Czech Republic)minorDistributor for VLVbio products in Czech Republic.
Scale indicators5 records
Recent moves8 records
Expansion highlights6 records
VLVbio competitors and assessment
Company assessmentDirect peers
- Bio-Techne: Major US-based manufacturer of ELISA kits, immunoassay reagents, and biomarker tools for research and clinical use. Directly comparable to VLVbio as both companies produce and distribute immunoassay products for cell biology and clinical diagnostics through global channels.
- Genfit: French biotech company that developed NIS4, a multi-biomarker blood test for MASH diagnosis. Directly competes with VLVbio's M30 Apoptosense in the non-invasive MASH diagnostic space.
- Nordic Bioscience: Danish biomarker company developing and commercializing blood-based biomarkers for fibro-inflammatory diseases including liver fibrosis. Directly comparable as a specialty biomarker assay company serving hepatology and clinical trial markets.
- Echosens: French developer of FibroScan, the leading non-invasive technology for liver disease assessment. Directly competes with VLVbio in the MASH/MASLD diagnostic market with an imaging-based rather than blood-based biomarker approach.
- SomaLogic: US-based specialty proteomics company offering the SomaScan platform for large-scale biomarker measurement. Comparable as a specialty biomarker platform company serving clinical research and drug development.
- Olink (Thermo Fisher Scientific): Swedish-origin specialty proteomics company (now part of Thermo Fisher) offering high-multiplex biomarker discovery platforms. Comparable as a Nordic-based specialty biomarker platform company with clinical applications in disease research.
Broad incumbents
- Roche Diagnostics: Major global IVD manufacturer with broad diagnostic portfolio including liver and metabolic disease tests. Indirect competition via dominant clinical lab instrument platforms.
- Siemens Healthineers: Major global IVD manufacturer with broad portfolio including liver diagnostics (e.g., ELF test for liver fibrosis). Competes with VLVbio at the clinical diagnostics level through established hospital lab channels.
- Abbott Diagnostics: Major global IVD manufacturer with broad portfolio of clinical chemistry, immunoassay, and point-of-care diagnostics. Indirect competitor in clinical liver and metabolic disease testing.
Emerging players
- Perspectum Diagnostics: UK-based liver diagnostics company offering MRI-based LiverMultiScan and related biomarker products for non-invasive liver disease assessment. Comparable as a non-invasive MASH/MASLD diagnostic company at earlier commercialization stage.
Market position
Strengths5 records
Weaknesses4 records
Competitive moat5 records
Key risks5 records
Key highlights6 records
Customer concentration
VLVbio social profiles
Digital presenceVLVbio compliance and trust
Trust signalCompliance2 records
VLVbio financial estimates
Financial estimateRevenue estimate
Valuation estimate
VLVbio leadership team
Management profileNumber of profiles
Profiles6 records
VLVbio funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
VLVbio M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about VLVbio
What does VLVbio do?
VLVbio manufactures, R&Ds, and sells the PEVIVA product line of ELISA-based in vitro diagnostic kits that detect keratin-18 (K18) biomarkers of epithelial cell death. The kits (M30 Apoptosense®, M65®, M65 EpiDeath®, M30 CytoDeath™, M65 EpiRat™) quantify hepatocyte apoptosis and total cell death for clinical diagnosis of MASH/MASLD and for pre-clinical and clinical research in hepatology and oncology.
Is VLVbio a public or private company?
VLVbio is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was VLVbio founded?
VLVbio was founded in 2013. It employs 1 to 10 people.
Where is VLVbio based?
VLVbio is headquartered in Nacka, Sweden, in the Europe region.
How does VLVbio make money?
Two revenue lines are on record. ELISA Kit Product Sales are the primary driver. The others are clinical Research Products.
Who are VLVbio's main competitors?
Direct peers on record are Bio-Techne, Genfit, Nordic Bioscience, Echosens, SomaLogic and Olink (Thermo Fisher Scientific). Broad incumbents are Roche Diagnostics, Siemens Healthineers and Abbott Diagnostics. Perspectum Diagnostics is listed as an emerging player.
Does VLVbio have an API?
No public API is recorded for VLVbio.
What industry is VLVbio in?
VLVbio's product category is In Vitro Diagnostics. Its primary akta.pro industry code is HLAGAEAB, Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry), with a secondary code of HLAGADAG, Proteomics & Biomarker Analytical Testing. Its NAICS code is 325413 and its SIC code is 2835.