Company history

Company profileCompany history

VEDALAB is a privately French owned company, founded in 1991

It is devoted to the development, production and marketing of in vitro immunodiagnostic reagents. As a market leader, VEDALAB focuses on international expansion by forming long-term partnerships with reliable and trustworthy distributors worldwide. Continually expanding its impressive range of products, VEDALAB is today the biggest rapid test manufacturer in Europe.

VEDALAB’s headquarters, its research and development, manufacturing and marketing departments are all located in a modern, well-equipped and expanding (4 500 m²) ISO certified plant in the beautiful Normandy town of Alençon. VEDALAB employs about 50 people all of whom are dedicated to the design, development, manufacture or promotion of a very wide range of innovative reagents and instruments, including the use of patented technologies.

Throughout its years of development, VEDALAB has acquired incomparable research experience ranging from initial antibody screening to the creation of its own manufacturing equipment. Such unparalleled experience has made VEDALAB a reference of quality in the world of immunodiagnostics.

VEDALAB’s headquarters in Cerisé / Alençon France
VEDALAB's headquarters in Cerisé / Alençon France
VEDALAB’s headquarters in Cerisé / Alençon France
VEDALAB's headquarters in Cerisé / Alençon France

History

  • 2018

    New quantitative rapid tests for reader use: HbA1c and Hb Total. CE marking of Gluten rapid test (Gluten'Alarm) for home use.

  • 2017

    New product development: PSA Free quantitative rapid test. Qualitative rapid test for the detection of Alanine Transaminase (ALT) and Aspartate transaminase (AST).

  • 2016

    New quantitative rapid tests for reader use: CA 15-3, CA 19-9, CALPROTECTIN, CORTISOL, TRANSFERRIN. Obtention of CE marking of Ebola rapid test (Ezyscreen). Launch of Trio TOXIN A+B+GDH qualitative rapid test.

  • 2015

    Extension of the company facility (300 m²). Launch of the new Easyreader+® quantitative rapid tests reader New product development: T3 quantitative rapid test for reader use. Legionella rapid test. Streptococcus pneumoniae rapid test.

  • 2014

    New product development: CYSTATIN C quantitative rapid test for Easy Reader use. HS-PROLACTIN quantitative rapid test for Easy Reader use. ULTRA-TSH quantitative rapid test for Easy Reader use.

  • 2013

    Extension of the company facility (700 m²). New product development: FABP rapid test. HS-INSULIN quantitative rapid test for Easy Reader use. Procalcitonin quantitative rapid test for Easy Reader use. T4 quantitative rapid test for Easy Reader use.

  • 2012

    New product development: Giardia lamblia, helicobacter pylori antigen (in feces), insulin qualitative rapid tests. Insulin quantitative rapid test for Easy reader use. FSH quantitative rapid test for Easy reader use. LH quantitative rapid test for Easy reader use. HS-CRP quantitative rapid test for Easy reader use. HS-TSH quantitative rapid test for Easy reader use.

  • 2011

    Celebration of the 20th anniversary of the company's creation. CE marking of Lyme (Tik'Alert®) for home use. CE marking of IgE (Allergy-Check®) for home use. Insulin quantitative rapid test for Easy Reader use. FSH quantitative rapid test for Easy Reader use.

  • 2010

    CE marking of Ferritin (Ferri-Check®) for home use. CE marking of helicobacter pylori (Pylori-Screen®) for home use. CE marking of TSH (Thyro-Check®) for home use. CA-125 quantitative rapid test for Easy Reader use. Micro-albumin quantitative rapid test for Easy Reader use. Quality system accreditation (CMDCAS) in Canada : ISO 13485 (2003).

  • 2009

    FOB quantitative rapid test for Easy reader use. EN ISO 9001 (2008) and EN ISO 13485 (2003) certification obtained from MDC GmbH notified body.

  • 2008

    CK-MB quantitative rapid test for Easy reader use. hCG quantitative rapid test for Easy reader use. CE marking of HEM (Poly-Check®) for home use.

  • 2007

    IgE quantitative rapid test for Easy reader use. New product development: Influenza A and B, C.d. Toxin B, Lyme IgG and IgM. CE marking of PSA (Prosta-Check®) for home use. CEA quantitative rapid test for Easy reader use. Prolactin quantitative rapid test for Easy reader use. AFP quantitative rapid test for Easy reader use.

  • 2006

    Ferritin quantitative rapid test for Easy reader use. Myoglobin quantitative rapid test for Easy reader use. New product development: Chagas qualitative rapid test. Departure of Milovan Stankov. Patent litigation settlement.

  • 2005

    NF EN ISO 13485 (2004) certification obtained from LNE/GMED (French notified body). Launch of VEDA.LAB rapid test reader (Easy Reader). PSA semi-quantitative and quantitative rapid test for Easy reader use. Troponin I quantitative rapid test for Easy reader use. TSH quantitative rapid test for Easy reader use. Uricheck biochemistry strips.

  • 2004

    Quality system management approved on the basis of ISO 9001 (2000) and ISO 13485 52001) standards.

  • 2003

    Full application of European IVD 98/79/CE requirements. GMP (EN 46001) certification renewal of the QA system by G-Med (French notified body). New products development. Launch of a rapid test reader optimized for PSA rapid test for quantitative results reading.

  • 2002

    Automation of production (2nd stage). Compliance with CE requirements. new products development.

  • 2001

    Celebration of the 10th anniversary of the company's creation. CE marking of Babycheck® and Evidence® pregnancy tests. Construction of the third phase of the GMP facility. New products development.

  • 2000

    Application of European IVD 98/79/CE. Extension of the QA certificate as per GMP (EN46001).

  • 1999

    QA system certified by the French QA association (AFAQ). New products developed: Adenovirus, Rotavirus, RSV.

  • 1998

    Automation of production (1st stage).

  • 1997

    Construction (extension) of the second phase of the GMP facility.

  • 1996

    New VEDA.LAB products developed in-house (cardiac markers, drugs of abuse, TB and syphilis) were launched on the international market.

  • 1995

    Set-up of the Quality Assurance system (QA) in compliance with ISO 9001 standards. Development of veterinary rapid tests (FIV, FeLV).

  • 1994

    Construction (extension) of the first phase of a new GMP facility.

  • 1993

    FDA approval of pregnancy test in USA (510K). Export of rapid tests to India, China, Russia and Latin America.

  • 1992

    Product launch on the US market. Development of other fertility tests (LH, FSH) and infectious disease rapid tests (Chlamydia and Strep A).

  • 1991

    Foundation of the company by Milovan Stankov and Raphael Donati. Launch of the Babycheck® pregnancy test in France and Europe.