What Biomedal does

Biomedal, S.L. is a privately held Spanish biotechnology company headquartered in Sevilla with laboratory and production facilities in Camas, operating across three divisions: in vitro diagnostics (iVYDAL), food and beverage analytical services, and life science research services. Its core technology is the detection of Gluten Immunogenic Peptides (GIP) using patented monoclonal antibodies G12 and A1, developed jointly with the University of Seville. The iVYDAL division offers professional-use products including the iVYLISA GIP Stool quantitative ELISA and iVYCHECK GIP Stool/Urine rapid immunochromatographic tests, plus the GlutenDetect home testing line sold direct-to-consumer and the GlutenPack standardized gluten sachets for clinical use.

The company generates revenue through one-time product sales of IVD kits to clinical laboratories and consumers, fee-for-service analytical testing for the agri-food industry (allergens, microbiological, physico-chemical), and custom biotechnology services (gene synthesis, recombinant protein expression across five systems, custom peptide synthesis, antibody production, and bioinformatics). Distribution is hybrid: direct B2B sales for professional diagnostics and lab services, and own e-commerce storefronts for consumer and life science services. Quality infrastructure is anchored by ISO 17025, ISO 9001, and ISO 13485 certifications across divisions, with reference laboratory status from FACE and ADILAC providing institutional credibility in the Spanish celiac and lactose-intolerance communities.

Financially, Biomedal is self-funded: no external VC or PE investment is evidenced. The company has received non-dilutive EU FEDER grants (~€251K in 2020 for COVID-related diagnostics and facility expansion, plus REACT-UE energy support) and participates in the ICEX Next internationalization program. In April 2025, Biomedal executed a partial spin-off, transferring real estate and asset management activities to a newly created BIGFAIVICS INVESTMENTS, S.L., leaving the biotech operating company leaner and more focused. The company currently lists Spain as its only served market and employs 11-50 people.

Name

Biomedal

Legal name

BIOMEDAL, S.L.

Website

https://biomedal.com/

Company type

Private

Founded year

2000

Operating status

Operating

Headcount range

11–50 employees

Short description

Biomedal is a Sevilla-based Spanish biotech company that develops patented GIP-detection diagnostics for celiac disease management (iVYDAL), ISO-accredited food safety testing, and custom life science research services. It serves clinical labs, celiac patients, food manufacturers, and biotech researchers.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

akta.pro secondary industries

Microbiology & Infectious Disease Testing (Trial Support) (HLAGAEAF), Clinical Chemistry & Immunoassay Laboratories (HLAFAMAB), Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB)

Keywords

• In vitro diagnostics
• Celiac disease testing
• Food allergen analysis
• Life science services
• Biotechnology research

Headquarters

HQ city

Sevilla

HQ country

Spain

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Supply Chain, Marketing or Sales

Revenue model

1. In Vitro Diagnostic Products: Sale of professional-use and home-use diagnostic tests for celiac disease monitoring. Products include iVYLISA GIP Stool (96-well ELISA kit), iVYCHECK GIP Stool and Urine rapid tests, and GlutenDetect home testing kits. Revenue generated through direct product sales to healthcare professionals and consumers.
2. Analytical Laboratory Services: Food and beverage analysis services for the agri-food industry including allergen analysis, microbiological testing, physico-chemical analysis, and other specialized food testing. Services offered to food manufacturers and the agri-food sector with emergency 24-hour turnaround available.
3. Life Science Research Services: Biotechnology services including genetic engineering (gene synthesis, oligo synthesis, sequencing), expression and purification of recombinant proteins, custom peptide synthesis, antibody production, and bioinformatics analysis. Services targeted at life sciences researchers and the biotechnology industry.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels3 records

Core offering

Biomedal is a biotechnology company that develops, manufactures, and commercializes in vitro diagnostic kits and laboratory services. Its flagship offering is the only non-invasive Gluten Immunogenic Peptides (GIP) detection technology for monitoring gluten-free diet adherence in celiac patients, using proprietary G12 and A1 monoclonal antibodies in ELISA and lateral flow formats. The company also operates ISO 17025-accredited food analytical laboratories and provides life science research services including gene synthesis, recombinant protein expression, peptide synthesis, and antibody production.

Product overview

Biomedal is a biotechnology company with a multi-divisional structure offering in vitro diagnostic products, analytical laboratory services, and life science services. The iVYDAL In Vitro Diagnostics division provides professional-use celiac disease management tools including iVYLISA GIP Stool (quantitative ELISA), iVYCHECK GIP Stool and iVYCHECK GIP Urine (rapid immunochromatographic tests), and GlutenPack (professional gluten sachets). The home testing division offers GlutenDetect Stool and Urine tests for patient self-monitoring of gluten-free diet compliance. The Analytical Services division provides ISO 17025 accredited food testing including allergen analysis, microbiological analysis, physico-chemical analysis, and COVID-19 surface detection. The Life Science division offers genetic engineering services (gene synthesis, oligo synthesis, sequencing), recombinant protein expression in five systems (E. coli, B. subtilis, yeast, baculovirus, mammalian cells), custom peptide synthesis, antibody production (polyclonal, monoclonal, phage libraries), and bioinformatics analysis.

Differentiator

Problem solved

Functional benefit

Brands

• iVYDAL In Vitro Diagnostics: In vitro diagnostic products for the diagnosis and management of celiac disease, including tests for detecting Gluten Immunogenic Peptides (GIP) in stool and urine samples
• iVYLISA GIP Stool
• iVYCHECK GIP Stool
• iVYCHECK GIP Urine
• GlutenDetect
• GlutenPack
• Biomedal Life Science
• Biomedal Servicios Analíticos

Products and services

• iVYLISA GIP Stool Quantitative Sandwich ELISA test for detection and quantification of Gluten Immunogenic Peptides (GIP) in stool samples. Uses G12 monoclonal antibody against the 33-mer peptide. For professional use in clinical analysis laboratories. 96-well format (catalog KT-5739).
• iVYCHECK GIP Stool Rapid immunochromatographic lateral flow test for qualitative detection of Gluten Immunogenic Peptides (GIP) in stool samples. Results in 15-30 minutes as red line (positive) or green control line. For professional use. Available in 25-test and 10-test formats.
• iVYCHECK GIP Urine Rapid immunochromatographic test for qualitative detection of Gluten Immunogenic Peptides (GIP) in urine samples. Urine sample mixed with Conditioning Solution before detection. For professional use by doctors, pharmacists, or specialists. Available in 25-test and 10-test formats.
• GlutenDetect Stool Test Rapid home test for detection of Gluten Immunogenic Peptides (GIP) in stool samples. Lateral flow strip similar to a pregnancy test format. Enables self-monitoring of gluten-free diet at home without visiting a medical center. Results in 15-30 minutes. 2-test format.
• GlutenDetect Urine Test Rapid home test for detection of Gluten Immunogenic Peptides (GIP) in urine samples. Lateral flow strip format for self-monitoring gluten-free diet adherence at home. Results in 15-30 minutes. Available in 1-test, 5-test, and 12-test formats.
• GlutenPack Individual 11g gluten sachets packaged in 30-unit packs. Designed for hospital environments, research centers, and laboratories requiring precision, convenience, and standardization in gluten handling. Available exclusively for professional use.
• Food Allergen Analysis Analytical service for detection of food allergens including gluten, milk proteins, nuts, egg, sulfites, and others. Performed at an ISO/IEC 17025 accredited laboratory that serves as a reference laboratory for FACE (Federation of Celiac Associations of Spain) and ADILAC (Association of Lactose Intolerant Spain).
• Microbiological Analysis Microbiological testing services for food including Salmonella, Listeria, and other pathogens, plus surface microbiology and water analysis. Emergency 24-hour turnaround available.
• Physico-chemical Analysis Physical-chemical analysis services for food and water including nutritional analysis, organoleptic testing, fatty acids, vitamins, heavy metals, sulfites, acidity, and phosphates.
• COVID-19 Detection on Surfaces PCR-based detection service for COVID-19 virus on surfaces. Designed to verify effectiveness of disinfection and cleaning protocols. Provides early detection with high specificity and sensitivity.
• Gene Synthesis De novo gene synthesis service producing double-stranded DNA genes up to 3,000 bp. Includes codon optimization, sequencing verification, and delivery of approximately 4 µg lyophilized DNA cloned into a vector. Efficiency greater than 99.9%.
• Oligo Synthesis Oligonucleotide synthesis service. DNA oligos from 12-140 bases, RNA oligos from 2-40 bases. Multiple purification methods (RP-cartridge, HPLC, PAGE). Quality controlled by MALDI mass spectrometry. Various modifications available for 5', 3', and internal positions.
• Sequencing Service DNA sequencing services including Sanger sequencing and Next-Generation Sequencing (NGS). NGS platforms include Ion Torrent, Illumina HiSeq 2500, and MiSeq. Results in 48 hours for Sanger sequencing.
• Recombinant Protein Expression and Purification Recombinant protein production service with five expression systems: E. coli, B. subtilis, yeast (P. pastoris, S. cerevisiae), baculovirus (Sf9, Sf21, Hi5), and mammalian cells (HEK, CHO). Capacity up to 24 L in flasks and over 100 L in bioreactors.
• Custom Peptide Synthesis Custom peptide synthesis service with no size limit in amino acid sequence, with all types of modifications available, guaranteed purity with HPLC and MS verification, COA documentation, 5-week delivery, and a 99% success rate. Backed by over 17 years of experience.
• Antibody Production Comprehensive antibody production services including polyclonal antibodies (rabbit, mouse, rat, chicken, goat, sheep, llama, alpaca) and monoclonal antibodies via hybridoma technology. Also offers phage library screening. From antigen design to purified antibody. Polyclonal success rate exceeds 99%.
• Bioinformatics Analysis Bioinformatics and statistical analysis services for genomics, transcriptomics, and proteomics data, providing expert guidance through all steps of data analysis from experiments.
• Clinical Trial Services for Celiac Disease Comprehensive services for celiac disease clinical trials including iVYDAL GIP detection products (stool and urine), clinical trial design, sample analysis and storage, final reports, and technical support.

Quantifiable outcome

• iVYLISA GIP Stool: 97.1% diagnostic sensitivity, 83.3% diagnostic specificity
• +6 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Four partnerships are on record, tiered core and minor.

• ICEX (Instituto de Comercio Exterior)coreGTM or Marketing Partner · 1 January 2021Biomedal participates in the ICEX Next Program for international development of Spanish companies, receiving support and co-financing from the European FEDER fund to advance international expansion efforts.
• University of Seville (Universidad de Sevilla)coreStrategic or Co-development PartnerJoint development and patenting of GIP detection technology using monoclonal antibodies G12 and A1. The collaboration between University of Seville and Biomedal SL resulted in proprietary technology for detecting Gluten Immunogenic Peptides in human samples for celiac disease monitoring.
• Federación de Asociaciones de Celíacos de España (FACE)coreOthersBiomedal is a reference laboratory for FACE (Federation of Celiac Associations of Spain), providing allergen testing services and GIP detection validation for the celiac community in Spain.
• Asociación de Intolerantes a la Lactosa España (ADILAC)minorOthersBiomedal holds reference laboratory status for ADILAC (Association of Lactose Intolerant Spain), providing lactose analysis services to support the lactose intolerance community.

Scale indicators6 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• SGS: Swiss-based global inspection, verification, testing and certification company with a substantial food and life sciences testing portfolio. Comparable to Biomedal's ISO 17025-accredited analytical services and life science offerings, particularly in allergen and microbiological testing.
• Eurofins Scientific: Global leader in food and pharmaceutical testing services, including allergen analysis, microbiological testing, and environmental analysis — directly comparable to Biomedal's Servicios Analíticos food testing division and life science services. Operates at vastly greater scale with global reach.
• Bio-Techne: Major life sciences tools company providing proteins, antibodies, ELISA kits, and diagnostics reagents. Comparable to Biomedal's antibody production and iVYDAL ELISA product lines; significantly larger and publicly listed with broader catalog.
• Inova Diagnostics (Werfen): Specialty diagnostics company (part of Werfen group) focused on autoimmune disease diagnostics, including celiac disease serology (anti-tTG, anti-endomysium). Comparable as a competitor in celiac disease diagnostic testing, though focused on serology rather than GIP detection.
• Prometheus Laboratories (Nestlé Health Science): Subsidiary of Nestlé Health Science historically focused on GI diagnostics including celiac disease serology and IBD. Comparable as a competitor in celiac disease monitoring, though Prometheus is now broader and Nestle-owned with significantly more distribution scale.

Direct peers

• GenScript: Global biotechnology company offering gene synthesis, peptide synthesis, antibody production, and protein expression services. Directly comparable to Biomedal's Life Science division across most of its service catalog (gene synthesis, peptide synthesis, antibody production, recombinant protein expression).

Regional players

• Grifols: Spanish-listed global healthcare company specializing in plasma-derived medicines and diagnostic systems. Comparable as a major Spanish-headquartered biotech/diagnostics company, though at much greater scale; useful benchmark for the Spanish biotech ecosystem and diagnostic commercialization pathways.
• PharmaMar: Spanish biotechnology company focused on oncology drug development, headquartered in Madrid. Comparable as a Spanish biotech of similar vintage and headcount scale, providing a regional benchmark for biotech operations in Spain, though operating in a different therapeutic area.

Emerging players

• Zedira: Specialty German biotech focused on transglutaminase and celiac disease research reagents, including diagnostic tools for celiac disease. Comparable as a niche player developing specialized celiac diagnostics, though Zedira's product focus is more research-grade than Biomedal's clinical/professional positioning.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInes.linkedin.com/company/biomedal
• Xx.com/biomedal

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Biomedal