What PRIMA Lab does

PRIMA Lab SA is a privately held Swiss in vitro diagnostic (IVD) manufacturer founded in 2014 and headquartered in Morbio Inferiore, Canton Ticino. The company designs, develops, and produces rapid diagnostic test kits based on lateral flow immunochromatographic technology, marketed under three sub-brands: PRIMA Home Test (self-testing for consumers), PRIMA Professional (clinical point-of-care use), and PRIMA Veterinary (animal health diagnostics). The product portfolio spans approximately 200 CE-marked devices across infectious disease (HIV 1/2, Strep A, CRP, UTI, vaginal pH), gastrointestinal (celiac disease, H. pylori, bowel FOB), check-up (Vitamin D, PSA, ferritin, IgE, kidney albumin, drug screening), fertility (LH, sperm, pregnancy, amniocheck, FSH), and veterinary (Giardia, NGAL kidney injury) indications, with the NGAL test positioned as a first-of-its-kind canine kidney damage screening assay.

The company's go-to-market is a hybrid B2B/B2C model executed primarily through distributor and local representative channels across more than 30 countries. Commercial partnerships with entities such as Eurosirel, IDI Pharma, Federfarma.co, Interlux, and Brands and More provide geographic reach, while the regulatory backbone rests on ISO 13485:2016 certification and CE marking under IVDD 98/79/EC (extended through May 2025), with an active portfolio transition to IVDR 2017/746 via notified body mdc (0483). All development, production, and packaging are conducted in-house at the Swiss facility, supporting quality control and rapid product iteration. Cumulative volumes exceed 20 million tests sold globally to date.

Revenue mechanics are driven by one-time unit sales of rapid test kits across consumer self-test and professional use channels, with pricing not publicly disclosed and commercial inquiries handled via direct sales representatives. The company employs 51-100 people, has no disclosed parent company, subsidiaries, or institutional funding rounds, and is described as founder-owned. Strategic milestones include being among the first to launch a CE-IVD COVID-19 serological test in Europe in 2020, the 2021 HIV ½ Self-Test launch, and the 2023 entry into veterinary diagnostics with the NGAL platform.

Name

PRIMA Lab

Legal name

PRIMA Lab SA

Website

https://primalabsa.ch

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

51–100 employees

Short description

PRIMA Lab SA is a Swiss manufacturer of CE-marked rapid diagnostic test kits based on lateral flow immunochromatographic technology, serving consumer self-testing, clinical point-of-care, and veterinary channels across 30+ countries through distributor and representative networks.

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

Laboratory & Point-of-Care Diagnostic Devices (Analyzers, Test Kits, Microscopy) (HLAMAFAI)

akta.pro secondary industry

Point-of-Care & In-Clinic Diagnostics (Rapid Tests, Benchtop Analyzers) (HLAMADAI)

Keywords

• Rapid diagnostic tests
• In vitro diagnostics
• Point-of-care testing
• Self-testing kits
• Veterinary diagnostics

Headquarters

HQ city

Balerna

HQ country

Switzerland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Rapid Diagnostic Test Sales: Revenue generated from the manufacture and sale of CE-marked rapid diagnostic tests across multiple product categories including infectious disease, gastrointestinal, check-up, fertility, and veterinary diagnostics. Tests are sold both for self-testing (consumer) and professional use (healthcare providers).

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

PRIMA Lab SA is a Swiss in vitro diagnostic (IVD) manufacturer that develops, evaluates, and produces CE-marked rapid diagnostic test kits. The portfolio of 200+ devices is organized into three product lines: PRIMA Home Test (consumer self-testing), PRIMA Professional (clinical use by healthcare providers), and PRIMA Veterinary (animal diagnostics), built on lateral flow immunochromatographic technology.

Product overview

PRIMA Lab SA is a Swiss in vitro diagnostic (IVD) manufacturer specializing in CE-marked rapid tests across three distinct product lines: PRIMA Home Test (self-testing for consumers), PRIMA Professional (diagnostic tests for healthcare professionals), and PRIMA Veterinary (animal health diagnostics). The company operates with fully in-house development, production, and packaging capabilities from its facility in Morbio Inferiore, Switzerland. The portfolio encompasses over 200 CE-marked devices spanning five therapeutic areas: infectious disease (HIV, Strep A, CRP, UTI, vaginal pH), gastrointestinal disorders (celiac disease, H. pylori, bowel FOB), check-up monitoring (Vitamin D, prostate PSA, iron FER, allergy IgE, kidney albumin, drug screening), fertility (ovulation LH, sperm, pregnancy, amniocheck, menopause FSH), and veterinary diagnostics (Giardia pet test, NGAL kidney screening). Tests are designed as lateral flow immunochromatographic devices providing rapid results at the point of care, with semi-quantitative readouts achieved through visual comparison against color charts.

Differentiator

Problem solved

Functional benefit

Brands

• PRIMA Home Test: Consumer-oriented rapid diagnostic tests for home use, including HIV self-tests, celiac disease screening, fertility tests, and general health monitoring.
• PRIMA Professional
• PRIMA Veterinary

Products and services

• HIV 1/2 Self-Test A CE-IVD rapid self-test for the detection of HIV-1 and HIV-2 antibodies, enabling at-home screening with results in minutes.
• C-Reactive Protein Test A rapid test for detecting C-Reactive Protein (CRP) in blood samples, used to monitor inflammation and infection status at home.
• Strep A Test A rapid test for detecting Group A Streptococcus antigens from a throat swab, enabling at-home differentiation of strep throat from viral pharyngitis.
• Urinary Tract Infections Test A rapid self-test for detecting urinary tract infection markers, enabling at-home screening for UTI symptoms.
• Vaginal pH Test A rapid test for measuring vaginal pH levels to help identify potential infections such as bacterial vaginosis or yeast infections.
• Celiac Disease Screening Test A rapid screening test for celiac disease designed for home use, detecting disease-specific biomarkers to support initial diagnosis.
• Helicobacter pylori Test A rapid test for detecting H. pylori antibodies in blood, used for at-home screening of Helicobacter pylori infection associated with peptic ulcers.
• Helicobacter pylori Antigen Test A rapid test for detecting H. pylori antigens in stool samples, enabling direct detection of active Helicobacter pylori infection at home.
• Bowel FOB Test A rapid fecal occult blood test for at-home screening of gastrointestinal bleeding, used as an early indicator for bowel disorders including colorectal cancer.
• Vitamin D Test A rapid self-test for measuring Vitamin D levels from a blood sample, supporting at-home monitoring of nutritional status.
• Prostate PSA Test A rapid test for detecting Prostate-Specific Antigen (PSA) in blood, designed for at-home screening to support prostate health monitoring.
• Iron FER Test A rapid self-test for measuring ferritin levels to assess iron deficiency or iron overload, supporting at-home monitoring of iron status.
• Allergy IgE Test A rapid test for detecting Immunoglobulin E (IgE) antibodies in blood, enabling at-home screening for allergic sensitization.
• Kidneys Albumin Test A rapid self-test for detecting albumin in urine to screen for kidney damage and monitor renal function at home.
• Drug Test A rapid test for detecting drugs of abuse in urine samples, enabling at-home substance screening.
• Ovulation LH Test A rapid test for detecting Luteinizing Hormone (LH) surge in urine to predict ovulation and identify the optimal fertility window.
• Sperm Test A rapid at-home test for evaluating sperm concentration to support male fertility assessment.
• Early Pregnancy Test A rapid test for detecting human Chorionic Gonadotropin (hCG) in urine for early pregnancy confirmation at home.
• Amniocheck A rapid test for detecting amniotic fluid in vaginal secretions, helping confirm rupture of membranes during pregnancy.
• Menopause FSH Test A rapid test for detecting Follicle-Stimulating Hormone (FSH) in urine to help identify the onset of menopause.
• Giardia Pet Test A rapid test for detecting Giardia antigens in pet stool samples, enabling at-home screening for giardiasis in dogs and cats.
• Helicobacter pylori Antigen Rapid Test (Professional) A rapid immunochromatographic test for professional use detecting H. pylori antigens in stool specimens for clinical diagnosis.
• Bowel FOB Rapid Test (Professional) A rapid fecal occult blood test for professional use in clinical settings to screen for gastrointestinal bleeding and bowel disorders.
• Celiac Rapid Test (Professional) A rapid test for professional use detecting celiac disease biomarkers, supporting clinical screening in healthcare settings.
• C-Reactive Protein Rapid Test (Professional) A rapid quantitative CRP test for professional use providing objective inflammatory marker measurement in clinical settings.
• Strep A Rapid Test (Professional) A rapid test for professional use detecting Group A Streptococcus antigens from throat swabs in clinical environments.
• Iron FER Rapid Test (Professional) A rapid quantitative ferritin test for professional use enabling objective iron deficiency assessment in clinical settings.
• Vitamin D Rapid Test (Professional) A rapid quantitative Vitamin D test for professional use providing objective measurement of Vitamin D levels in clinical practice.
• KI Screening Test The first rapid lateral flow immunochromatographic test for semi-quantitative detection of Neutrophil Gelatinase Associated Lipocalin (NGAL) in dog urine, enabling early screening of kidney damage in dogs. Results are available in 10 minutes with 97.6% sensitivity and 98.15% specificity.

Quantifiable outcome

• NGAL test achieves 97.6% sensitivity and 99.21% sensitivity for detecting kidney injury in dogs

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Six partnerships are on record, tiered minor and core.

• EurosirelminorChannel Partner/ Reseller/ DistributorPartner logo displayed on PRIMA Lab website partnership section. Nature of partnership appears to be commercial distribution or reseller relationship.
• IDI PharmaminorChannel Partner/ Reseller/ DistributorPartner logo displayed on PRIMA Lab website partnership section. Nature of partnership appears to be commercial distribution or reseller relationship.
• Federfarma.cominorChannel Partner/ Reseller/ DistributorPartner logo displayed on PRIMA Lab website partnership section. Nature of partnership appears to be commercial distribution or reseller relationship.
• InterluxminorChannel Partner/ Reseller/ DistributorPartner logo displayed on PRIMA Lab website partnership section. Nature of partnership appears to be commercial distribution or reseller relationship.
• Brands and MoreminorChannel Partner/ Reseller/ DistributorPartner logo displayed on PRIMA Lab website partnership section. Nature of partnership appears to be commercial distribution or reseller relationship.
• mdc (Medical Device Certification)coreOthersPRIMA Lab's Quality Management System is certified by mdc, which has been designated as a Notified Body for IVDR services (NANDO). mdc issues PRIMA Lab's CE certificates including CE certificate # D1408400052 under IVDD 98/79/EC, valid until May 2025 for self-testing devices.

Scale indicators3 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Healgen Scientific: Healgen Scientific is a global manufacturer of lateral flow rapid diagnostic tests across infectious disease, fertility, and drugs-of-abuse categories, directly competing with PRIMA Lab's PRIMA Home Test and PRIMA Professional portfolios in similar OTC and clinical channels.
• SD Biosensor: SD Biosensor is a Korean IVD manufacturer specializing in rapid diagnostic test kits for infectious disease, cardiology, and other areas, competing head-to-head with PRIMA Lab in CE-marked lateral flow tests distributed across multiple geographies.
• BTNX Inc. BTNX is a Canadian biotechnology company that develops and manufactures rapid test kits for clinical and at-home use, including infectious disease and fertility, directly comparable to PRIMA Lab's product lines and CE/Health Canada dual-market approach.
• Nal von Minden GmbH: Nal von Minden is a German manufacturer of rapid diagnostic tests including drug screening, infectious disease, and fertility tests under the MoLab and NADAL brands, directly competing with PRIMA Lab in European pharmacy and professional channels.
• Hangzhou AllTest Biotech: AllTest Biotech is a Chinese IVD manufacturer of lateral flow rapid tests covering infectious disease, fertility, tumor markers, and cardiac markers, competing with PRIMA Lab across multiple CE-marked SKUs in distributor and OEM channels.
• Biopanda Reagents: Biopanda Reagents is a UK-based manufacturer of lateral flow rapid diagnostic test kits for infectious disease, fertility, drugs of abuse, and veterinary use, overlapping with PRIMA Lab's three sub-brands including PRIMA Veterinary.

Broad incumbents

• Abbott Rapid Diagnostics: Abbott is a global diagnostics incumbent with broad lateral flow and POC test portfolios (Binax, Panbio, Clearview), competing with PRIMA Lab in human infectious disease and OTC self-testing while serving as the de facto scale benchmark for the segment.
• Roche Diagnostics: Roche Diagnostics is a global incumbent offering a wide range of IVD products including rapid tests for pregnancy, infectious disease, and clinical chemistry, serving as both a competitor and a market-shaping benchmark for European IVD manufacturers like PRIMA Lab.
• QuidelOrtho: QuidelOrtho is a broad diagnostics incumbent specializing in rapid immunoassays and POC testing (Sofia, Triage, QuickVue), with overlapping product categories in infectious disease and consumer-facing rapid tests relevant to PRIMA Lab's professional and home lines.
• IDEXX Laboratories: IDEXX is a global veterinary diagnostics incumbent offering in-clinic chemistry, hematology, and rapid tests for companion animals; its scale in vet channels makes it the dominant reference point for evaluating PRIMA Lab's NGAL-based veterinary expansion.

Market position

Strengths1 record

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/channel/UCfzcbRDaOxmO0wYumtyf75g
• LinkedInlinkedin.com/company/primahometest
• Facebookfacebook.com/primahometest

Compliance3 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 PRIMA Lab