What LaCAR MDx does

LaCAR MDx Technologies is a Belgian in vitro diagnostics company founded in December 2013 in Liège through collaboration with the genetic unit of the University of Liège. The company designs, develops, manufactures, and commercializes CE-IVD certified diagnostic kits, automated instruments, and interpretation software across three domains: newborn screening, pharmacogenetics, and genetic predispositions and disorders. Its portfolio addresses clinical needs ranging from early detection of congenital and metabolic disorders in newborns, to prevention of adverse drug reactions through pharmacogenetic testing, and identification of inherited risk factors for thrombosis, autoimmune disease, and food intolerance. LaCAR serves approximately 250 diagnostic laboratories and healthcare institutions across more than 50 countries.

The product portfolio rests on multiple molecular diagnostic modalities. The core proprietary technology is LAMP (Loop-mediated Isothermal Amplification), which enables DNA extraction-free genetic testing directly from EDTA whole blood and reduces pharmacogenetic assay turnaround times to under one hour. The portfolio also includes immunoassay and enzymatic fluorometric kits for metabolic and endocrine newborn screening, a multiplex qPCR assay for SCID and SMA, mass spectrometry-based kits for hemoglobinopathies, and the SEEKER digital microfluidics platform acquired through the 2025 Baebies acquisition. Supporting automation includes the NEO-F-500 fluorometric workstation, the NEO-M-300 Hamilton robotic system, the Genie III isothermal amplification instrument, and proprietary interpretation software (GeneFox, GeneFoxCub). LaCAR holds ISO 13485, MDSAP, and CE-IVDR certifications and was the first company globally to offer an IVDR-compliant combined SMA/SCID kit.

LaCAR generates revenue through a mix of capital equipment sales (automated instruments and workstations), consumable kit sales with recurring reagent orders, software licenses, and professional services for training and integration. The company employs 78 people across four locations: the Liège headquarters and production facility, a North Carolina operational site acquired via Baebies, an Italian subsidiary (Biosense Italy) for public tender participation, and regional sales offices. Distribution combines direct field sales through dedicated regional account managers covering Germany, Italy, Iberia, Benelux, Switzerland, and LATAM, with channel partners and distributors for broader geographic reach. Following 20% operational growth in 2024, the company secured EU/Walloon regional co-funding in 2026 for a new MDSAP-compliant production laboratory and is executing on a multi-year strategy that includes U.S. market entry via Baebies.

Name

LaCAR MDx

Legal name

LaCAR MDx Technologies

Website

https://lacar-mdx.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

11–50 employees

Short description

LaCAR MDx is a Belgian in vitro diagnostics company that designs, manufactures, and sells CE-IVD certified kits, automated instruments, and interpretation software for newborn screening, pharmacogenetics, and genetic predisposition testing, serving 250+ diagnostic laboratories across 50+ countries.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Clinical Chemistry & Hematology Diagnostics (automated analyzers, blood testing) (HLAAALAH)

akta.pro secondary industries

Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL), Hematology & Coagulation Diagnostics (HLAHAAAB)

Keywords

• Newborn screening diagnostics
• Pharmacogenetic testing kits
• LAMP diagnostic assays
• Molecular diagnostics platforms
• In vitro diagnostics

Headquarters

HQ city

Liège

HQ country

Belgium

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. CE-IVD Diagnostic Kits: LaCAR designs, develops, produces, and commercializes CE-IVD certified diagnostic kits across three areas: newborn screening (immunoassays, qPCR, mass spectrometry, digital microfluidics), pharmacogenetics (LAMP-based kits for TPMT, NUDT15, DPD, CYP2C9, CYP2C19), and genetic predispositions & disorders (thrombosis, hemochromatosis, HLA-B27, food intolerance). Kits are sold as one-time purchases with repeat orders for reagents and consumables.
2. Automated Instruments and Workstations: Sale of automated sample preparation and analysis instruments including NEO-C-500, NEO-F-500, NEO-M-300, SEEKER, Genie III, and BSD Robotics punchers. These instruments are sold as capital equipment, often bundled with kit contracts.
3. Interpretation Software (GeneFoxCub, GeneFox): Specialized software licenses for automated interpretation and management of diagnostic results. Software supports laboratory workflows and ensures regulatory compliance, likely sold as subscriptions or site licenses.
4. Customer Support and Technical Services: Personalized technical support, on-site training, integration assistance, and demonstration services provided alongside product sales to ensure optimal kit use and workflow integration.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels8 records

Core offering

LaCAR MDx designs, develops, produces, and commercializes CE-IVD/IVDR certified diagnostic kits, automated instruments, and interpretation software for three areas: newborn screening (immunoassays, qPCR, mass spectrometry, digital microfluidics), pharmacogenetics (LAMP-based kits for TPMT, NUDT15, DPD, CYP2C9, CYP2C19), and genetic predispositions and disorders (thrombosis, hemochromatosis, HLA-B27, food intolerance). The company delivers a complete workflow from dried blood spot sample collection through automated preparation and analysis to result interpretation software.

Product overview

LaCAR MDx offers a comprehensive diagnostic ecosystem combining kits, instruments, and software for newborn screening, pharmacogenetics, and genetic predisposition testing. The portfolio includes immunoassay and enzymatic fluorometric kits (PKU, MSUD, G6PD, Biotinidase, TSH, 17-OHP, IRT, GAL-T, T-GAL) for metabolic and endocrine disorders; qPCR-based DNA analysis kits (SCID & SMA) and mass spectrometry tests (Targeted MS/MS Hemo for hemoglobinopathies); digital microfluidics-based SEEKER® platform for lysosomal storage diseases; LAMP-based pharmacogenetic kits (TPMT, NUDT15, DPD, CYP2C9, CYP2C19) without DNA extraction; and genetic predisposition tests for thrombosis (Factor V Leiden, Prothrombin, MTHFR, PAI-1), autoimmune diseases (HLA-B27), food intolerance (lactose intolerance), and hemochromatosis. Supporting platforms include NEO-F-500 and NEO-M-300 automated workstations, Genie® III isothermal amplification instrument, GeneFoxCub and GeneFox interpretation software, and 903® dried blood spot collection cards. All products are CE-IVD/IVDR certified and ISO 13485 compliant.

Differentiator

Problem solved

Functional benefit

Brands

• GeneFoxCub: Software developed by FoxWare for LaCAR, designed to automate and optimize neonatal screening workflows, providing standardized, accelerated, and reliable diagnosis with regulatory compliance.
• GeneFox
• SEEKER

Products and services

• NEONATAL PKU Screening Fluo Fluorescent enzymatic test for quantitative determination of phenylalanine levels in newborns from dried blood spots, enabling early detection of phenylketonuria (PKU). Designed for diagnostic laboratories and newborn screening programs.
• NEONATAL MSUD Screening Fluo Enzymatic test for fluorescence detection of branched-chain amino acids (leucine, isoleucine, valine) accumulated in maple syrup urine disease (MSUD). For diagnostic laboratories.
• NEONATAL G-6-PD Screening Fluo Enzymatic assay for precise quantitative measurement of G-6-PD activity in neonatal dried blood spots, aiding detection of glucose-6-phosphate dehydrogenase deficiency. For diagnostic laboratories.
• NEONATAL BTD Screening Fluo Enzymatic assay for quantitative measurement of biotinidase activity levels in newborns using dried blood spots for detection of biotinidase deficiency. For diagnostic laboratories.
• NEONATAL TSH Screening FLISA Fluorescent sandwich ELISA for quantitative measurement of thyroid stimulating hormone (TSH) in neonatal dried blood spots for congenital hypothyroidism screening. For diagnostic laboratories.
• NEONATAL 17-OHP Screening FLISA Competitive fluorescent enzyme immunoassay for quantitative measurement of 17 alpha-hydroxyprogesterone (17-OHP) from dried blood spots for congenital adrenal hyperplasia (CAH) screening. For diagnostic laboratories.
• NEONATAL IRT Screening FLISA Fluorescent sandwich ELISA for quantitative determination of immunoreactive trypsinogen (IRT) from dried blood spots for cystic fibrosis newborn screening. For diagnostic laboratories.
• NEONATAL GAL-T Screening Fluo Enzymatic assay for quantitative determination of galactose-1-phosphate uridyltransferase (GAL-T) activity levels for galactosemia screening. For diagnostic laboratories.
• NEONATAL T-GAL Screening Fluo Enzymatic test for fluorescence detection of D-galactose and galactose-1-phosphate for neonatal galactosemia screening. For diagnostic laboratories.
• NEONATAL SCID & SMA Screening qPCR Flex Kit Multiplex qPCR assay for semi-quantitative TREC detection (SCID screening) and qualitative SMN1 exon 7 detection (SMA screening) from dried blood spots, with results in under 2.5 hours and up to 93 samples per plate. Fully CE-IVDR compliant - the first SMA/SCID kit on the market to achieve this.
• Targeted MS/MS Hemo Mass spectrometry-based newborn screening kit for hemoglobinopathies including sickle cell disease, thalassemia syndromes, and structural variants using triple quadrupole MS/MS system with Multiple Reaction Monitoring.
• LAMP Human TPMT Deficiency Kit LAMP-based in vitro diagnostic test for qualitative detection of TPMT alleles (*3B, *3C, *2) associated with thiopurine intolerance, performed directly from EDTA whole blood without DNA extraction, with results in under 1 hour.
• LAMP Human NUDT15 Deficiency Kit LAMP-based diagnostic test for qualitative detection of NUDT15 alleles (*3, *6, *9) associated with thiopurine toxicity risk, particularly common in Asian populations. CE-IVDR certified, works directly on EDTA whole blood without DNA extraction.
• LAMP Human DPD4var Kit LAMP-based test for qualitative detection of four DPYD non-functional/less functional alleles (*2A, *13, c.2846A>T, HapB3) for DPD deficiency screening prior to fluoropyrimidine therapy. CE-IVDR certified, no DNA extraction required.
• LAMP Human DPD5var Kit

Quantifiable outcome

• Turnaround time under 1 hour for pharmacogenetic LAMP assays (e.g., TPMT, NUDT15, DPD kits)
• +4 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

Integration2 records

Feature9 records

Partnerships

One partnership is on record.

• Baebies, Inc. (Newborn Screening Division)coreTechnology or Integration · 12 March 2025LaCAR MDx acquired the Newborn Screening division of Baebies, Inc., a U.S. company known for its innovative neonatal diagnostic technologies. This acquisition gives LaCAR access to the SEEKER digital microfluidics platform for lysosomal storage disease (LSD) screening, a North Carolina operational site for U.S. market entry, and accelerates commercialization of Baebies' products outside the United States. The acquisition reinforces LaCAR's newborn screening portfolio and strengthens its presence in the U.S. market.

Scale indicators9 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Revvity: Revvity (formerly PerkinElmer Life Sciences) is the global market leader in newborn screening reagents, instruments, and software, offering comprehensive solutions across SCID, SMA, LSD, and metabolic disorder screening. Directly comparable to LaCAR as both sell integrated NBS kits-instruments-software ecosystems, but at vastly larger scale and with established US public health contracts.
• Bruker Corporation: Bruker is a major scientific instruments and clinical diagnostics company with mass spectrometry-based IVD solutions comparable to LaCAR's Targeted MS/MS Hemo product. Both compete in clinical mass spec applications for hemoglobinopathies and metabolic disorders, though Bruker operates at much larger scale across broader analytical markets.
• Hologic: Hologic operates a significant molecular diagnostics franchise (Panther system, Aptima assays) with expanding pharmacogenetic content. Comparable as a molecular diagnostics kit and instrument provider targeting hospital and reference laboratories, though Hologic's core focus is women's health and infectious disease rather than newborn screening.
• QIAGEN: QIAGEN is a global leader in molecular sample preparation, PCR/qPCR reagents, and pharmacogenetics testing solutions. Directly comparable in the pharmacogenetic testing workflow (sample-to-result kits) and broader molecular diagnostics space, though at much larger scale and with broader infectious disease and oncology focus.
• Bio-Rad Laboratories: Bio-Rad is a major IVD manufacturer with a long-standing newborn screening and clinical diagnostics portfolio (BioPlex 2200, VARIANT systems, qPCR diagnostics). Directly comparable product categories across blood spot testing, hemoglobinopathy screening, and clinical chemistry/hematology diagnostics — but with significantly broader portfolio and larger R&D budget.

Direct peers

• EKF Diagnostics: EKF Diagnostics is a small-cap IVD company specializing in point-of-care hemoglobin/hematology testing and clinical chemistry reagents. Comparable in scale (sub-200M revenue) and product focus on blood-based diagnostics, though EKF skews more toward POC while LaCAR focuses on central lab IVD kits.
• ELITech Group: ELITech is a European-headquartered IVD specialty manufacturer with a comparable portfolio in molecular diagnostics, clinical chemistry, and niche specialty testing. Similar scale and customer mix (hospital and reference laboratories) make ELITech one of the closest publicly-traded analogues to LaCAR's business model and go-to-market approach.
• Sebia: Sebia is a specialty diagnostics company focused on hemoglobinopathy screening and clinical electrophoresis — directly overlapping with LaCAR's Targeted MS/MS Hemo kit for sickle cell disease and thalassemia screening. Both serve central laboratories in the newborn screening market with specialty diagnostic kits and instruments.

Emerging players

• Trivitron Healthcare: Trivitron is an India-based emerging-market IVD manufacturer with growing newborn screening, hematology, and clinical chemistry product lines. Directly comparable in targeting emerging-market newborn screening expansion, though with less differentiated technology and primarily regional rather than European regulatory positioning.

Others

• SCIEX (Danaher): SCIEX is a leading mass spectrometry instrument manufacturer whose triple quadrupole systems underpin LaCAR's Targeted MS/MS Hemo newborn screening kit. An adjacent/ecosystem relationship rather than direct competitor — SCIEX provides the analytical platform while LaCAR provides the diagnostic application kits and software for hemoglobinopathy screening.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/lacar_mdx
• LinkedInlinkedin.com/company/lacar-mdx-technologies

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Subsidiaries3 records

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 LaCAR MDx