About Us

Evolving to meet your needs.

BioAssay Works, LLC (BAW) powers the development of the finest rapid immunoassays. Utilizing our high sensitivity concentrated gold sols, high-performance gold conjugates, and our patented lateral-flow test platform, BAW develops and manufactures rugged lateral-flow tests that rival the sensitivity of ELISA. These tests can be read visually for quick positive/negative results or with simple instruments for more quantitative results.

Our milestones

BioAssay Works is evolving to meet the needs of customers and a changing market to become a leading assay development partner-of-choice for both early-stage and established companies.

  • 2005

    BioAssay Works
    Founded

    BioAssay Works is founded by three entrepreneurs with over 75 years of combined experience in developing, producing, and selling tools for research and diagnostic assay development. Their goal was simple — produce the best gold nanoparticles to make rapid tests more sensitive.

  • 2005

    Naked Gold® Superior Gold
    Nanoparticles Launched

    The first highly concentrated gold nanoparticles are commercially available under the Naked Gold trade name. Produced using a proprietary process that does not involve the traditional boiling and centrifugation methods, Naked Gold sols are highly concentrated (15 – 50 OD/mL) and offer a significant sensitivity over traditional gold sols.

  • 2006

    Dressed Gold® Gold
    Conjugates Offered

    Building on the success of the Naked Gold® nanoparticles, BioAssay Works launches line of gold conjugates. The Dressed Gold® conjugates offered rapid assay producers with potent ready-to-use gold conjugates.

  • 2009

    BioAssay Works Makes
    Isotyping Rapid

    BioAssay Works launches the Iso-Gold™ Isotyping Kits, one of the first 5-minute assays to determine the isotype of mouse monoclonal antibodies. Utilizing superior gold nanoparticles and our assay development expertise, these kits make isotyping an antibody quick and easy.

  • 2011

    Superior Lateral
    Flow Device Patented

    US Patents #7,910,381 and #7,344,893 are awarded for immuno gold lateral flow assays. The resultant C-Flat® lateral flow assay platform further enhances assay sensitivity.

  • 2015

    BioAssay Works Celebrates
    10 Years!

    We celebrate our first 10 years in business. Since founding, BioAssay works has developed dozens of custom assays and has manufactured hundreds of thousands of rapid diagnostic devices for some of the leading diagnostic customers!

  • 2015

    BioAssay Works
    Expands

    BioAssay Works adds 2,000 square feet of additional Manufacturing and Research & Development space, positioning the company to better serve our growing customer base.

  • 2018

    ISO 13485:
    2016 Registered

    BioAssay Works receives ISO 13485:2016 registration.

  • 2024

    BioAssay Works Expands
    Manufacturing Capabilities

    BioAssay Works adds an additional 1,000 square feet of Manufacturing space and acquires equipment to further automate our lateral flow manufacturing processes.

Our quality
system

BioAssay Works operates a Quality Management System which is certified to ISO 13485:2016. This certification covers the development and manufacture of lateral flow assays, components, and reagents used in IVD medical devices. For a copy of BioAssay Works’ certificate, please click here.

BioAssay Works Quality Policy
BioAssay Works is committed to meeting applicable requirements, maintaining the effectiveness of the Quality Management System (QMS), and increasing customer satisfaction through continual improvement of its products, services and the QMS.

Our management team

  • Les Kirkegaard Headshot

    Les Kirkegaard, MBA

    Vice President

    Marketing & Business Development

    Les joined BAW in 2016 with over 30 years of marketing and sales experience. In previous roles, he was responsible for product management, marketing, and sales of veterinary diagnostic and life science research product lines. Les leads the worldwide sales, marketing and business development efforts at BioAssay Works. He also manages many of the project teams developing custom lateral flow assays for BAW clients.

  • Olivier Côté Headshot

    Olivier Côté, PhD

    Executive Vice President

    Research & Development

    Dr. Olivier Côté obtained his PhD in Pathobiology (Molecular biology) from the University of Guelph, Canada in 2014. He has over 10 years of experience in the development of lateral flow assays (LFAs). At BAW, he has worked on over 80 client development projects and successfully helped them rapidly enter the market. He is an expert at trouble-shooting LFAs by root cause analyses and protocol optimization. Olivier leads the R&D team in design development and control of LFAs under ISO 13485.

  • Marc Berman headshot

    Marc Berman

    Vice President

    Operations

    Marc joined BAW in 2019 with over 30 years of Operations experience. In his previous roles, he has provided leadership in both day to day tactical actions as well as creating the long-term strategic vision in Lean Manufacturing, Production Planning, Supply Chain Management and Facility Engineering for medical device, research reagent and industrial component manufacturers under various regulatory and quality standards such as ISO 13485, ISO 9001, cGMP, USDA, UL, ATEX/IEX and others. Marc leads the Operations and Quality teams at BAW.

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