PRIMA Lab


PRIMA Lab SA is dedicated to creating a world where pathologies can be detected early through innovative, high-quality diagnostic devices developed in Switzerland. Their mission emphasizes prevention, collaboration, and excellence in manufacturing, with a focus on rapid, accurate testing for human and veterinary health across various fields including infectious diseases, gastrointestinal disorders, check-ups, fertility, COVID-19, and pet health. They are committed to compliance with international standards such as ISO 13485 and IVDR regulations, ensuring their products meet the highest quality and regulatory requirements.

Industries

manufacturing
medical
medical-device

Nr. of Employees

medium (51-250)

PRIMA Lab


Products

Celiac antibody rapid test (IgG anti-DGP and IgA anti-tTG) — home and professional formats

Lateral-flow rapid test for detection of antibodies against deamidated gliadin peptides (DGP) and tissue transglutaminase (tTG) in whole blood, serum or plasma for celiac disease screening. Available in consumer and professional presentations.

Helicobacter pylori tests (antibody and stool antigen) — home and professional formats

Rapid tests for detection of Helicobacter pylori: antibody detection in whole blood and antigen detection in stool. Available in home and professional presentations.

Bowel FOB rapid test (occult blood in stool) — home and professional

Rapid lateral-flow test for detection of occult blood in stool samples for gastrointestinal bleeding screening, offered in consumer and professional formats.

Vitamin D semiquantitative rapid test (home and professional)

Semiquantitative lateral-flow test for detection of 25-hydroxyvitamin D in whole blood, available in self-test and professional formats.

COVID-19 antigen self-test (nasal) — home

Rapid nasal swab self-test for qualitative detection of SARS-CoV-2 nucleocapsid antigens for home screening.

COVID-19 saliva antigen self-test

Rapid saliva-based self-test for qualitative detection of SARS-CoV-2 antigens for non-invasive home screening.

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Services

Supply of consumer self-test IVD kits

Provision and distribution of self-test kits intended for consumer/home use across multiple health categories (infectious disease, fertility, check-up, gastrointestinal, COVID-19).

Supply of professional-use IVD kits

Provision and distribution of professional in-vitro diagnostic tests and multi-pack rapid tests intended for use by healthcare professionals and laboratories.

Veterinary diagnostic kit supply

Provision of rapid tests for veterinary use, including fecal antigen detection and semiquantitative urine biomarker kits for animal health screening.

Regulatory transition and IVDR support

Advisory support for transition to the EU IVDR framework, including documentation alignment, notified-body interaction guidance and market-entry assistance.

Expertise Areas

  • Lateral-flow rapid diagnostic development
  • Semiquantitative point-of-care assay design
  • Point-of-care and self-test product engineering
  • Rapid-test chemistry for urine, stool, saliva and blood
  • Show More (6)

Key Technologies

  • Immunochromatographic lateral-flow assays
  • Semiquantitative lateral-flow readouts
  • Antigen detection assays
  • Serology/antibody detection assays
  • Show More (6)

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