Biocartis NV
- Company typePrivate
- Founded2007
- HeadquartersMechelen, Belgium
- Headcount251–500
- GTM typeB2B
- OfferingHardware or Manufacturing
Biocartis NV firmographics
Firmographics- Name
- Biocartis NV
- Legal name
- Biocartis NV
- Website
- https://biocartis.com
- Company type
- Private
- Founded year
- 2007
- Operating status
- Operating
- Headcount range
- 251–500 employees
- Ownership category
- akta.pro rank
Biocartis NV industry classification
Industry- Product category
- Molecular Diagnostics Instruments & Assays
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD)
- akta.pro secondary industries
- Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Companion Diagnostics (CDx) & Therapy Selection Assays (HLAAALAF), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)
Keywords
Where Biocartis NV is headquartered
LocationHeadquarters
- HQ city
- Mechelen
- HQ country
- Belgium
- HQ region
- Europe
Offices3 records
Markets served
Biocartis NV business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Supply Chain, Personnel, Marketing or Sales, Operations
Revenue model
- Idylla Instrument Sales/Leasing: Biocartis generates revenue through the sale or lease of the Idylla molecular diagnostics instrument platform to laboratories and hospitals.
- Diagnostic Test Consumables: Recurring revenue from sale of assay cartridges and test kits (Oncology Tests and Research Assays) that run on the Idylla platform. Assays include EGFR, BRAF, KRAS, NRAS-BRAF, MSI, GeneFusion, POLE-POLD1, IDH1-2, PIK3CA-AKT1, ctEGFR, ctKRAS, ctNRAS-BRAF, ThyroidPrint, and CDx MSI Test.
- Pharmaceutical Companion Diagnostics Partnerships: Revenue from companion diagnostic collaborations with pharmaceutical companies for drug development and patient stratification, including the Idylla CDx MSI Test for nivolumab/ipilimumab therapy selection.
Go-to-market motion2 records
Distribution channels3 records
Marketing channels8 records
Biocartis NV product offering
Product offeringCore offering
Biocartis develops, manufactures, and commercializes the Idylla platform, a fully automated real-time PCR-based molecular testing system that delivers sample-to-answer molecular biomarker results in approximately 3 hours. The company sells the Idylla instrument together with a menu of IVD oncology assays (EGFR, BRAF, KRAS, NRAS-BRAF, MSI, GeneFusion) including the FDA-approved and IVDR Class C-certified Idylla CDx MSI Test, an extensive portfolio of Research Use Only assays, and APIS-branded digital PCR kits. Customers include hospital and reference laboratories, oncologists, pathologists, oncology researchers, and pharmaceutical companies for companion diagnostic collaborations.
Product overview
Biocartis offers the Idylla platform, a fully automated, real-time PCR-based molecular diagnostics system that delivers results in approximately 3 hours. The platform supports a broad menu of oncology tests including IVDR/IVDD-certified in vitro diagnostics (Idylla EGFR Mutation Test, Idylla GeneFusion Panel, Idylla BRAF/KRAS/NRAS-BRAF Mutation Tests, Idylla CDx MSI Test, Idylla MSI Test) and an extensive portfolio of Research Use Only (RUO) assays (including MSI, POLE-POLD1, ThyroidPrint, EGFR, BRAF, KRAS, NRAS-BRAF-EGFR S492R, IDH1-2, PIK3CA-AKT1, ctEGFR, ctKRAS, ctNRAS-BRAF-EGFR S492R assays). The company also offers APIS-branded digital PCR and qPCR kits for research applications. Tests process molecular biomarkers from FFPE tissue sections and liquid biopsy samples, with the CDx MSI Test serving as a companion diagnostic for immunotherapy patient selection.
Differentiator
Problem solved
Functional benefit
Brands
- Idylla: Revolutionary, fully automated real-time PCR based molecular testing system for oncology biomarker testing
- Idylla Platform
- Idylla CDx MSI Test
- Idylla MSI Assay
- Idylla EGFR Mutation Test
- Idylla BRAF Mutation Test
- Idylla KRAS Mutation Test
- Idylla NRAS-BRAF Mutation Test
- Idylla GeneFusion Panel
- APIS ESR1 dPCR Kit
- ThyroidPrint
Products and services
- Idylla Platform Fully automated, real-time PCR-based molecular testing instrument that delivers sample-to-answer molecular biomarker results in approximately 3 hours. Designed for use by hospital and reference laboratories without specialized molecular biology expertise.
- Idylla CDx MSI Test Companion diagnostic test that qualitatively detects microsatellite instability (MSI) status in colorectal cancer tissue samples within three hours. Indicated to identify patients who may benefit from nivolumab/ipilimumab combination therapy. FDA-approved and IVDR Class C certified.
- Idylla EGFR Mutation Test In vitro diagnostic test for detecting EGFR mutations, IVDR certified (A0270/6).
- Idylla BRAF Mutation Test In vitro diagnostic test for BRAF mutation detection (A0010/6 | IVDD).
- Idylla KRAS Mutation Test In vitro diagnostic test for KRAS mutation detection (A0020/6 | IVDD).
- Idylla NRAS-BRAF Mutation Test Combined in vitro diagnostic test for NRAS-BRAF mutation detection (A0030/6 | IVDD).
- Idylla GeneFusion Panel In vitro diagnostic test for gene fusion detection (A0120/6 | IVDD).
- Idylla MSI Test In vitro diagnostic test for microsatellite instability detection (A0100/6 | IVDD).
- Idylla MSI Assay (RUO) Research Use Only assay that performs detection of microsatellite instability directly from FFPE human cancer tissue sections utilizing PCR reaction followed by high-resolution melting curve analysis. Detects mutations in 7 novel MSI loci (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, SULF2) with approximately 150 minutes assay turnaround time and less than 3 minutes hands-on time (A0101/6 | RUO).
- Idylla POLE-POLD1 Mutation Assay (RUO) Research Use Only assay for POLE-POLD1 mutation detection (A0281/6 | RUO).
- APIS ESR1 dPCR Kit Digital PCR kit for ESR1 mutation detection, Research Use Only.
Quantifiable outcome
- Molecular biomarker results in approximately 3 hours (vs. traditional methods taking days)
- +3 more outcomes
Companies that use Biocartis NV
Customer profileNamed customers1 record
Segments4 records
Ideal customer profiles4 records
Biocartis NV technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Biocartis NV partnerships and signals
Strategic signalPartnerships
13 partnerships are on record, tiered regional and core.
- A&B d.o.oregionalDistributor for Croatia, handling sales and support of Biocartis products in the Croatian market.
- Abacus dxregionalDistributor for Australia and New Zealand, responsible for local sales, distribution, and customer support of the Idylla platform and assays.
- Advance Test Est.regionalDistributor for Saudi Arabia and Bahrain, providing local sales and distribution services for Biocartis products.
- Advanced Technology CompanyregionalDistributor for Kuwait, handling sales and distribution of Idylla products in the Kuwaiti market.
- Al Zahrawi Medical Supplies LLCregionalDistributor for Oman and UAE (Dubai), providing local sales, distribution, and support for Biocartis molecular diagnostics products.
- Alatheia Medical, S.A.regionalDistributor for Chile, handling sales and distribution of Biocartis products in the Chilean market.
- Alfa HealthcareregionalDistributor for Egypt, Tunisia, and Libya, providing local sales and distribution services for the Idylla platform in North Africa.
- UAB Nova naturaregionalDistributor for Estonia, Latvia, and Lithuania (Baltic states), handling sales and distribution of Biocartis products.
- UniscienceregionalDistributor for Brazil, responsible for sales, distribution, and support of Idylla products in the Brazilian market.
- VibagregionalDistributor for Ecuador, handling sales and distribution of Biocartis molecular diagnostics products.
- Web Trading Concern Pvt. Ltd.regionalDistributor for Nepal, providing local sales and distribution services for Biocartis products.
- Wonderful Life Science Co Ltd.regionalDistributor for Taiwan, handling sales and distribution of Idylla products in the Taiwanese market.
- Pharmaceutical and Diagnostic/Biomarker CompaniescoreBiocartis maintains partnership programs with pharmaceutical companies for companion diagnostic development and with diagnostic or biomarker companies for menu expansion. The Idylla CDx MSI Test is indicated to identify patients who may benefit from nivolumab/ipilimumab combination therapy ( Bristol-Myers Squibb products).
Scale indicators3 records
Recent moves6 records
Expansion highlights6 records
Biocartis NV competitors and assessment
Company assessmentBroad incumbents
- bioMérieux: Diversified in vitro diagnostics company with BIOFIRE FilmArray and molecular oncology/infection panels; competes with Biocartis for lab automated testing footprints and CDx partnerships.
- Roche Diagnostics: Broad diagnostics incumbent offering cobas PCR and NGS-based oncology assays (EGFR, KRAS, BRAF, MSI) on an installed hospital-lab base; overlaps with Idylla's menu but as part of a much larger IVD portfolio.
- Abbott Molecular: Offers the m2000 and Alinity m automated real-time PCR molecular diagnostics platforms with oncology and infectious disease menus, competing head-to-head with Idylla for hospital and reference-lab placements.
Direct peers
- QIAGEN: Provides sample-to-answer PCR and NGS-based molecular diagnostics, including companion diagnostics and oncology biomarker panels, with global distribution footprint similar to Biocartis.
- GenMark Diagnostics (Roche): Now part of Roche, GenMark provides the ePlex fully-automated sample-to-answer molecular platform with syndromic and oncology test menus — a close competitive analogue to Idylla's fully automated PCR value proposition.
- Cepheid (Danaher): Direct competitor with the GeneXpert line of fully automated real-time PCR systems delivering sample-to-answer molecular diagnostics across infectious disease, oncology and hospital-acquired infection menus — closest analogue to Biocartis' Idylla in workflow and use cases.
- Hologic (Panther/Granger): Operates the Panther Fusion fully-automated molecular platform targeting hospital and reference labs; an established automated PCR/NAAT competitor in the same capital-equipment-plus-consumables model as Idylla.
Emerging players
- Vela Diagnostics: Provides automated PCR and NGS-based oncology companion diagnostics and infectious disease kits on the Sentosa platform; partial overlap with Idylla's automated molecular diagnostics positioning.
- Accelerate Diagnostics: Smaller automated molecular diagnostics company developing sample-to-answer platforms; competes with Idylla in the niche of decentralised, easy-to-use molecular testing in hospital labs.
- QuidelOrtho: Molecular diagnostics and immunoassay provider offering PCR-based assays for hospital and reference labs; an adjacent automated molecular competitor with overlapping customer targets.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
Biocartis NV social profiles
Digital presenceBiocartis NV financial estimates
Financial estimateRevenue estimate
Valuation estimate
Biocartis NV leadership team
Management profileNumber of profiles
Profiles4 records
Biocartis NV subsidiaries and ownership
Company hierarchySubsidiaries1 record
Biocartis NV funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Biocartis NV 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 Biocartis NV
What does Biocartis NV do?
Biocartis develops, manufactures, and commercializes the Idylla platform, a fully automated real-time PCR-based molecular testing system that delivers sample-to-answer molecular biomarker results in approximately 3 hours. The company sells the Idylla instrument together with a menu of IVD oncology assays (EGFR, BRAF, KRAS, NRAS-BRAF, MSI, GeneFusion) including the FDA-approved and IVDR Class C-certified Idylla CDx MSI Test, an extensive portfolio of Research Use Only assays, and APIS-branded digital PCR kits. Customers include hospital and reference laboratories, oncologists, pathologists, oncology researchers, and pharmaceutical companies for companion diagnostic collaborations.
Is Biocartis NV a public or private company?
Biocartis NV is a private company. It is classified as unknown and is currently operating.
When was Biocartis NV founded?
Biocartis NV was founded in 2007. It employs 251 to 500 people.
Where is Biocartis NV based?
Biocartis NV is headquartered in Mechelen, Belgium, in the Europe region.
How does Biocartis NV make money?
Three revenue lines are on record. Idylla Instrument Sales/Leasing is the primary driver. The others are diagnostic Test Consumables and pharmaceutical Companion Diagnostics Partnerships.
Who are Biocartis NV's main competitors?
Broad incumbents on record are bioMérieux, Roche Diagnostics and Abbott Molecular. Direct peers are QIAGEN, GenMark Diagnostics (Roche), Cepheid (Danaher) and Hologic (Panther/Granger). Emerging players are Vela Diagnostics, Accelerate Diagnostics and QuidelOrtho.
Does Biocartis NV have an API?
No public API is recorded for Biocartis NV.
What industry is Biocartis NV in?
Biocartis NV's product category is Molecular Diagnostics Instruments & Assays. Its primary akta.pro industry code is HLAHAAAD, Molecular Diagnostics (PCR/NAAT/NGS-based IVD), with a secondary code of HLAAALAE, Oncology Diagnostics (tumor profiling, MRD, liquid biopsy). Its NAICS code is 325413 and its SIC code is 2835.