Biocartis
Biocartis is a Belgium-based molecular diagnostics company that commercializes the Idylla Platform — a fully automated real-time PCR system delivering oncology biomarker results in approximately 3 hours — serving clinical laboratories, oncologists, pathologists, and pharmaceutical CDx partners across 75+ countries.
- Company typePrivate
- Founded2007
- HeadquartersMechelen, Belgium
- Headcount101–250
- GTM typeB2B
- OfferingHardware or Manufacturing
What Biocartis does
Biocartis NV is a Belgium-headquartered molecular diagnostics company that develops and commercializes the Idylla Platform, a fully automated, real-time PCR-based sample-to-answer system designed to deliver oncology biomarker results in approximately 3 hours with less than 3 minutes of hands-on time. The company serves clinical laboratories, oncologists, pathologists, oncology researchers, and pharmaceutical partners, with a menu spanning FDA-approved and IVDR-certified companion diagnostic tests (including the Idylla CDx MSI Test for colorectal cancer), IVD oncology assays (EGFR, BRAF, KRAS, NRAS-BRAF, MSI, GeneFusion Panel), an extensive RUO research assay portfolio, and APIS-branded dPCR/qPCR kits. It reaches approximately 2,000 customers across 75+ countries through a hybrid model combining direct enterprise field sales, Molecular Technical Specialist-led demonstrations, and an extensive global distributor network, with a wholly-owned US subsidiary (Biocartis US Inc.) supporting North American operations. Revenue is generated through Idylla instrument hardware sales plus recurring cartridge consumables, RUO assay sales, and pharmaceutical CDx partnership and licensing arrangements. Biocartis operates with approximately 200 employees, has cumulatively raised roughly $418M across nine disclosed funding rounds between 2009 and 2020, and has undergone a major corporate restructuring while continuing to extend its regulatory footprint (FDA approval and EU IVDR Class C certification) and platform menu.
Biocartis firmographics
Firmographics- Name
- Biocartis
- Legal name
- Biocartis NV
- Website
- https://biocartis.com
- Company type
- Private
- Founded year
- 2007
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- Biocartis is a Belgium-based molecular diagnostics company that commercializes the Idylla Platform — a fully automated real-time PCR system delivering oncology biomarker results in approximately 3 hours — serving clinical laboratories, oncologists, pathologists, and pharmaceutical CDx partners across 75+ countries.
- Ownership category
- akta.pro rank
Biocartis industry classification
Industry- Product category
- Molecular Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Services-Testing Laboratories (8734)
- akta.pro primary industry
- Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD)
- akta.pro secondary industries
- Biomarker Discovery & Validation (omics, assay feasibility, clinical validation) (HLAAAMAA), Translational Medicine & Biomarkers (HLAIALAF), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Genomics & Molecular Diagnostics (Trial Support) (HLAGAEAD)
Keywords
Where Biocartis is headquartered
LocationHeadquarters
- HQ city
- Mechelen
- HQ country
- Belgium
- HQ region
- Europe
Offices2 records
Markets served
Biocartis business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales, Infrastructure
Revenue model
- Idylla Platform Hardware: Sale of Idylla instrument systems to laboratories and healthcare institutions. The platform is a benchtop molecular diagnostics system that labs purchase to run Biocartis cartridge-based tests.
- Diagnostic Test Cartridges (Consumables): Recurring revenue from sale of proprietary test cartridges for use on the Idylla platform. Tests include EGFR, BRAF, KRAS, NRAS-BRAF, MSI, GeneFusion Panel, and other oncology biomarker assays.
- Research Assays (RUO): Sale of Research Use Only assays for biomarker investigation, including POLE-POLD1, IDH1-2, PIK3CA-AKT1, ctEGFR, ctKRAS, and ctNRAS-BRAF mutation assays.
- Pharmaceutical Partnership & Licensing: Partnerships with pharmaceutical companies for companion diagnostic development and co-commercialization, including licensing of patents and technology.
Go-to-market motion1 record
Distribution channels2 records
Marketing channels7 records
Biocartis product offering
Product offeringCore offering
Biocartis develops and commercializes the Idylla Platform, a fully automated real-time PCR-based molecular testing system that delivers sample-to-answer oncology biomarker results in approximately 3 hours with less than 3 minutes of hands-on time. The company sells the benchtop Idylla instrument together with proprietary single-use test cartridges (IVD and RUO) covering cancer biomarkers such as EGFR, BRAF, KRAS, NRAS, MSI, gene fusions, ctDNA targets, and additional research markers. It also partners with pharmaceutical companies to co-develop companion diagnostics and licenses related technology.
Product overview
Biocartis is a molecular diagnostics company offering the Idylla Platform, a fully automated, sample-to-answer real-time PCR system for oncology diagnostics. The product portfolio consists of the Idylla Platform as the core instrument system, complemented by FDA-approved and IVDR-certified companion diagnostic tests (including Idylla CDx MSI Test for colorectal cancer) and a comprehensive menu of IVD oncology tests (EGFR, BRAF, KRAS, NRAS-BRAF, MSI, GeneFusion Panel). The company also provides an extensive range of Research Use Only (RUO) assays covering the same biomarkers plus additional targets (POLE-POLD1, IDH1-2, PIK3CA-AKT1, ThyroidPrint) and liquid biopsy assays (ctEGFR, ctKRAS, ctNRAS-BRAF-EGFR S492R). Additionally, Biocartis offers APIS branded digital PCR (dPCR) and quantitative PCR (qPCR) kits for research applications. The platform delivers results in approximately 3 hours with minimal hands-on time, enabling rapid molecular testing suitable for any laboratory setting.
Differentiator
Problem solved
Functional benefit
Brands
- Idylla: Fully automated molecular testing platform for oncology diagnostics providing sample-to-answer results in approximately 3 hours
- Idylla CDx MSI Test
- Idylla MSI Test
Products and services
- Idylla Platform A fully automated, real-time PCR based benchtop molecular testing system that provides sample-to-answer diagnostics. Delivers molecular biomarker results in approximately 3 hours with less than 3 minutes hands-on time, designed to make molecular testing easy, fast and suitable for any laboratory setting without specialized molecular expertise.
- Idylla CDx MSI Test FDA-approved and IVDR Class C certified companion diagnostic test for rapid detection of microsatellite instability-high (MSI-H) in colorectal cancer tissue samples. Indicated as an aid to identify adult patients with MSI-H metastatic colorectal cancer who may benefit from treatment with nivolumab in combination with ipilimumab.
- Idylla EGFR Mutation Test Real-time PCR IVD test for detection of EGFR mutations, used in oncology diagnostics for lung cancer and other applications on the Idylla Platform.
- Idylla BRAF Mutation Test Real-time PCR IVD test for detection of BRAF mutations, used in melanoma and colorectal cancer diagnostics on the Idylla Platform.
- Idylla KRAS Mutation Test Real-time PCR IVD test for detection of KRAS mutations, used in colorectal cancer and other oncology applications on the Idylla Platform.
- Idylla NRAS-BRAF Mutation Test Real-time PCR IVD test for simultaneous detection of NRAS and BRAF mutations on the Idylla Platform.
- Idylla MSI Test Real-time PCR IVD test for microsatellite instability detection in colorectal cancer tissue samples on the Idylla Platform.
- Idylla GeneFusion Panel Real-time PCR panel for detection of gene fusions used in oncology diagnostics on the Idylla Platform.
- Idylla EGFR Mutation Assay (RUO) Research use only assay for detection of EGFR mutations, providing the same technology as the IVD test for research applications on the Idylla Platform.
- Idylla MSI Assay (RUO) Research use only assay that performs detection of microsatellite instability from FFPE tissue. Detects mutations in 7 MSI loci (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, and SULF2) with approximately 150 minutes turnaround time and less than 3 minutes hands-on time. Does not require paired normal tissue samples.
- Idylla POLE-POLD1 Mutation Assay (RUO) Research use only assay for detection of POLE and POLD1 mutations on the Idylla Platform.
- Idylla ThyroidPrint Assay (RUO) Research use only assay for thyroid cancer diagnostics on the Idylla Platform.
- Idylla IDH1-2 Mutation Assay (RUO) Research use only assay kit for detection of IDH1 and IDH2 mutations on the Idylla Platform.
- Idylla PIK3CA-AKT1 Mutation Assay (RUO) Research use only assay for detection of PIK3CA and AKT1 mutations on the Idylla Platform.
- Idylla ctEGFR Mutation Assay (RUO) Circulating tumor DNA assay for research use only, detecting EGFR mutations from liquid biopsy samples on the Idylla Platform.
- Idylla ctKRAS Mutation Assay (RUO) Circulating tumor DNA assay for research use only, detecting KRAS mutations from liquid biopsy samples on the Idylla Platform.
- Idylla ctNRAS-BRAF-EGFR S492R Mutation Assay (RUO) Circulating tumor DNA assay for research use only, detecting NRAS, BRAF, and EGFR S492R mutations from liquid biopsy samples on the Idylla Platform.
- APIS ESR1 dPCR Kit (RUO) Digital PCR kit for research use only, detecting ESR1 mutations. Distributed under the APIS brand as part of Biocartis' research assay portfolio.
- APIS ESR1 qPCR Kit (RUO) Quantitative PCR kit for research use only, detecting ESR1 mutations. Distributed under the APIS brand as part of Biocartis' research assay portfolio.
- APIS ESR1 & PIK3CA qPCR Kits Bundle (RUO) Bundle of quantitative PCR kits for research use only, detecting both ESR1 and PIK3CA mutations. Distributed under the APIS brand as part of Biocartis' research assay portfolio.
Quantifiable outcome
- Over 97% concordance with standard MSI/dMMR testing methods
- +2 more outcomes
Companies that use Biocartis
Customer profileNamed customers2 records
Segments4 records
Ideal customer profiles4 records
Biocartis technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Biocartis partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- City of HopecoreBiocartis announced an agreement with City of Hope to explore development of a rapid, blood-based, sample-to-answer gene signature test for early detection of pancreatic cancer on the Idylla Platform. Under the deal, Biocartis secured an option to license key patents and related know-how from City of Hope to accelerate test development. The test remains investigational and not yet available for diagnostic use. Dr. Ajay Goel of City of Hope noted that their microRNA-based liquid biopsy signature platform has demonstrated ability to detect cancers that current FDA-approved noninvasive tests miss across multiple international patient cohorts.
Scale indicators5 records
Recent moves5 records
Expansion highlights5 records
Biocartis competitors and assessment
Company assessmentMarket position
Competitive moat5 records
Key highlights6 records
Customer concentration
Biocartis social profiles
Digital presenceBiocartis compliance and trust
Trust signalCompliance2 records
Biocartis financial estimates
Financial estimateRevenue estimate
Valuation estimate
Biocartis leadership team
Management profileNumber of profiles
Profiles18 records
Biocartis subsidiaries and ownership
Company hierarchySubsidiaries1 record
Biocartis funding detail
Funding detailFunding overview
Funding rounds9 records
Investors17 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Biocartis M&A and investment
M&A and investmentM&A
Investments2 records
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Biocartis
What does Biocartis do?
Biocartis develops and commercializes the Idylla Platform, a fully automated real-time PCR-based molecular testing system that delivers sample-to-answer oncology biomarker results in approximately 3 hours with less than 3 minutes of hands-on time. The company sells the benchtop Idylla instrument together with proprietary single-use test cartridges (IVD and RUO) covering cancer biomarkers such as EGFR, BRAF, KRAS, NRAS, MSI, gene fusions, ctDNA targets, and additional research markers. It also partners with pharmaceutical companies to co-develop companion diagnostics and licenses related technology.
Is Biocartis a public or private company?
Biocartis is a private company. It is classified as venture growth investor backed and is currently operating.
When was Biocartis founded?
Biocartis was founded in 2007. It employs 101 to 250 people.
Where is Biocartis based?
Biocartis is headquartered in Mechelen, Belgium, in the Europe region.
How does Biocartis make money?
Four revenue lines are on record. Idylla Platform Hardware is the primary driver. The others are diagnostic Test Cartridges (Consumables), research Assays (RUO) and pharmaceutical Partnership & Licensing.
Does Biocartis have an API?
No public API is recorded for Biocartis.
What industry is Biocartis in?
Biocartis's product category is Molecular Diagnostics. Its primary akta.pro industry code is HLAHAAAD, Molecular Diagnostics (PCR/NAAT/NGS-based IVD), with a secondary code of HLAAAMAA, Biomarker Discovery & Validation (omics, assay feasibility, clinical validation). Its NAICS code is 325413 and its SIC code is 2835.