Certest Biotec

What Certest Biotec does

Certest Biotec, S.L. is a privately held Spanish biotechnology company founded in 2002 and headquartered in San Mateo de Gállego, Zaragoza. It develops and manufactures in vitro diagnostic (IVD) products for human clinical use, organized into three business units: Diagnostics (five technology platforms — Rapid Test lateral flow, Turbilatex turbidimetry, VIASURE real-time PCR, VIASURE NGS, and CLIA chemiluminescence), Alaset (raw materials including antibodies, antigens, enzymes, primers, probes, fluorophores, quenchers, and master mixes sold to other IVD manufacturers), and Pharma (RNA and oligonucleotide therapeutics built on 1,500+ proprietary ionizable lipids for LNP-based delivery).

The company monetizes through one-time sales of diagnostic kits and raw materials, transaction-based revenue from the BD partnership distributing VIASURE assays through the BD MAX System menu in European clinical labs, and the future licensing potential of its LNP and RNA therapeutic platform. Pricing is quote-based B2B with no public list prices, and products are sold directly to clinical laboratories, hospitals, and IVD manufacturers rather than to consumers.

Certest holds IVDR certification under EU Regulation 2017/746 (since 2024), MDSAP, and Responsible Business Alliance certifications, and distributes to 130+ countries across all continents, with flagship commercial partnerships including BD (since 2017) and the RAPID-VAC strategic project for RNA vaccines and biological defense. Recent moves include the March 2026 launch of Certest Resist CARBAS, the November 2025 rebranding of the Raw Materials unit as Alaset, and continued expansion into the Chinese and U.S. markets via CACLP and ADLM conferences in 2026.

Name

Certest Biotec

Legal name

Certest Biotec, S.L.

Website

https://certest.es

Company type

Private

Founded year

2002

Operating status

Operating

Short description

Certest Biotec is a Spanish IVD manufacturer (founded 2002, Zaragoza) selling diagnostic kits, raw materials (Alaset), and RNA/LNP therapeutics to clinical labs, IVD manufacturers, and pharma companies across 130+ countries, with a flagship BD partnership on the BD MAX System.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

akta.pro secondary industries

Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI), Non-viral Gene Delivery & Gene Therapy (LNP, polymers, electroporation, physical methods) (HLAAACAC)

Keywords

• In vitro diagnostics
• Molecular diagnostic assays
• Immunochromatographic rapid tests
• Diagnostic raw materials
• RNA therapeutics delivery

Headquarters

HQ city

Zaragoza

HQ country

Spain

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. IVD Diagnostic Products: Sale of diagnostic products including Rapid Tests, Turbilatex reagents, VIASURE PCR kits, VIASURE NGS solutions, and CLIA reagents for detection of infectious diseases and other biomarkers in clinical samples
2. Raw Materials (Alaset): Sale of raw materials including antibodies, antigens, enzymes, primers, probes, and master mixes to other IVD manufacturers and research institutions for developing their own diagnostic products
3. Pharma - RNA Therapeutics: Development and potential licensing of RNA-based therapeutics and LNP delivery technology for nucleic acid therapies
4. BD Partnership Revenue: Revenue from partnership with BD for VIASURE assays distributed through BD MAX System menu in European clinical laboratories

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels8 records

Core offering

Certest Biotec develops and manufactures in vitro diagnostic (IVD) products for human clinical applications across five complementary technology platforms: immunochromatographic lateral flow tests (Rapid Test), turbidimetry reagents (Turbilatex), real-time PCR kits (VIASURE), next-generation sequencing solutions (VIASURE NGS), and chemiluminescence reagents (CLIA). The company also supplies raw materials for IVD development (antibodies, antigens, enzymes, primers, probes, master mixes under the Alaset brand) and develops RNA therapeutics and lipid nanoparticle delivery technology (Certest Pharma) with 1,500+ proprietary ionizable lipids.

Differentiator

Problem solved

Functional benefit

Brands

• VIASURE: Real Time PCR platform providing ready-to-use molecular assays for sensitive and specific detection of infectious pathogens.
• VIASURE NGS
• Certest Rapid Test
• Turbilatex
• Certest CLIA
• Certest Pharma
• Certest ResisCheck
• Alaset

Products and services

• Certest Rapid Test One-step immunochromatographic lateral flow tests for qualitative detection of antigens in clinical samples. Used by clinical laboratories and healthcare facilities for rapid point-of-care diagnosis of infectious diseases and other biomarkers.
• Turbilatex Quantitative immunodiagnostic turbidimetry reagents for high-sensitivity detection and quantification of antigens, with fecal antigen detection as a primary application. Sold to clinical laboratories for quantitative diagnostic testing.
• VIASURE Real Time PCR Detection Kits Ready-to-use molecular diagnostic assays for sensitive and specific detection of infectious pathogens via real-time PCR. Available in liquid and lyophilized formats, including respiratory virus panels (SARS-CoV-2, influenza, RSV), sexually transmitted infections (HSV-1, HSV-2, syphilis), and other infectious disease panels. Distributed through the BD MAX System under partnership with BD since 2017.
• VIASURE NGS Solutions Next-generation sequencing solutions including lyophilized library preparation kits and a proprietary bioinformatic tool to streamline sequencing workflows. Targets clinical laboratories and research institutions performing advanced molecular analysis.
• Certest CLIA Reagents Chemiluminescence immunoassay reagents for diagnosis of infectious diseases, with specialization in gastrointestinal infections. Sold to clinical laboratories running automated chemiluminescence platforms.
• Alaset Raw Materials Bulk diagnostic raw materials including antibodies, antigens, enzymes, primers, probes (Taqman, Biolocked, MGB), fluorophores, quenchers, and master mixes for IVD manufacturers and research institutions developing their own immunodiagnostic and molecular diagnostic products. Includes optimized Taq DNA polymerase and reverse transcriptase.
• Certest Resist CARBAS (Certest ResisCheck Carbapenemases) Rapid immunochromatographic test for qualitative detection and differentiation of five carbapenemase enzyme families (KPC, OXA-48-like, VIM, IMP, NDM) in bacterial isolates. Delivers results in 15 minutes. CE-IVDR certified and manufactured in Europe for clinical microbiology laboratories performing antimicrobial resistance screening.
• Certest Pharma RNA Therapeutics and LNP Delivery Development of novel RNA sequences (short and long/complex RNA) and refined lipid nanoparticle (LNP) formulations using 1,500+ proprietary ionizable lipids for targeted nucleic acid delivery. Serves pharmaceutical and biotechnology companies developing RNA-based therapeutics, vaccines, and gene therapies through licensing and co-development partnerships.

Quantifiable outcome

• Detection of five carbapenemases (KPC, OXA-48-like, VIM, IMP, NDM) in 15 minutes
• +2 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

Feature5 records

Partnerships

One partnership is on record.

• BD (Becton, Dickinson and Company)flagshipStrategic or Co-development Partner · 15 December 2025Partnership since 2017 for development and distribution of VIASURE molecular diagnostic assays on the BD MAX System. In December 2025, two VIASURE assays received IVDR certification: a respiratory virus panel detecting SARS-CoV-2, influenza, and RSV, and an assay for HSV-1, HSV-2, and syphilis detection. The partnership enables clinical laboratories across Europe to perform automated molecular testing with results delivered in approximately three hours.

Scale indicators6 records

Recent moves6 records

Expansion highlights7 records

Broad incumbents

• bioMérieux: Global IVD leader with deep portfolios in microbiology, immunoassays and molecular diagnostics (BioFire FilmArray). Direct overlap with Certest in infectious disease rapid tests and PCR assays, but operates at much larger scale and broader menu.
• Hologic: US-based molecular diagnostics leader (Panther system, Aptima assays) with strong overlap to Certest's STI/HSV/syphilis and respiratory testing on BD MAX. Larger installed base and broader FDA-cleared menu.
• QIAGEN: Major player in molecular diagnostics and sample technologies with extensive PCR and NGS reagent menus. Comparable in PCR kit and raw-material offering, with significantly larger global footprint.

Direct peers

• Cepheid (Danaher): Direct competitor to BD MAX-based molecular workflows through the GeneXpert system; both Certest and Cepheid target infectious disease PCR in clinical labs. Comparable menu scope (respiratory, STI, AMR).
• R-Biopharm: German mid-sized IVD manufacturer specializing in clinical diagnostics, food/feed testing and rapid immunoassays. Closely comparable to Certest in lateral flow and turbidimetric reagents serving European clinical labs.
• ELITechGroup: European IVD company offering molecular diagnostics (sample-to-result), clinical chemistry and microbiology reagents. Similar mid-sized footprint, overlapping PCR/immunoassay menu and EU regulatory profile.
• Seegene: Korean molecular diagnostics company with multiplex PCR (Allplex) assays for respiratory, STI and gastrointestinal pathogens. Comparable menu and syndromic testing approach; competes head-to-head in global tenders.
• Meridian Bioscience (Revvity): IVD manufacturer of immunoassays, molecular reagents and raw antigens/antibodies. Comparable business model to Certest combining finished diagnostics with raw materials supply to other IVD developers.
• Acuitas Therapeutics: Specialist in lipid nanoparticle delivery technology for nucleic acid therapeutics, including partnerships with major vaccine developers. Comparable to Certest Pharma's LNP/RNA delivery focus, though narrower scope.

Regional players

• EKF Diagnostics: UK-headquartered diagnostics group with point-of-care hemoglobin, clinical chemistry and infectious disease rapid tests. Comparable mid-cap European IVD profile with overlapping rapid test offering.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• Instagraminstagram.com/certestbiotec
• Xx.com/certestbiotec
• LinkedInlinkedin.com/company/certest-biotec-s.l.

Revenue estimate

Valuation estimate

Number of profiles

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 Certest Biotec