ASSAY DEVELOPMENT

YOUR TRUE PARTNER IN ASSAY DEVELOPMENT

ZeptoMetrix is the most trusted partner for assay manufacturers across the assay development process.Our scientists provide the most comprehensive product and custom services portfolio to help you reach your assay development goals.

Interested in learning more? Download our brochure now.

Your Partner Across All Four Stages of Development

With over 20 years of experience working with top assay manufacturers, we have the expertise and portfolio required for total cycle support.

1
CONCEPT & FEASIBILITY
Rapidly demonstrate project viability and proof of concept.
Demonstrating early stage feasibility is a critical step of an assay development project. Using high-quality materials in proof-of-concept studies can save time and money and ultimately help avoid project delays.
2
ANALYTICAL VALIDATION
Generate data for regulatory submission.
Regulatory submissions require manufacturers to demonstrate assay performance through a series of rigorous testing protocols. High-quality materials help streamline these studies and generate accurate, reproducible data.
3
DEVELOPMENT & MANUFACTURING
Scale-up growing operations without delay.
Transitioning from validation to manufacturing scale can be a challenging process. A consistent supply of critical materials for internal QC can help ensure an efficient and affective transition while adhering to rigorous quality standards.
4
COMMERCIALIZATION & LAUNCH
Facilitate quick and easy assay adoption.
Having verification panels and quality control products that are designed to work on your assay and available to your customers can greatly simplify this process and facilitates rapid and easy adoption of your assay.
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Single Source Partner for Quality Controls and Microorganisms

At ZeptoMetrix, we partner with assay developers like you through all the stages of assay development—from assay concept and design to the development of custom controls for product development as well as ready-to-use external quality controls and panels for labs.

Explore Our Diverse Portfolio for IVD Development Excellence

  • Organisms for analytical testing
  • Custom controls and validation materials for internal testing (batch release)
  • Controls for clinical studies
  • Organism sourcing
  • Recombinant generation
  • Proficiency testing surveys
  • Antibodies and reagents for immunoassay development
  • Design history or technical file support

What Makes Us Different

The foundation of our success is based upon a sincere partnership approach with collaborators and subject matter experts in both industry and academia as well as a dedicated team to support though the full development process.

Areas of Expertise

  • Bacteriology / mycology / parasitology
  • Virology
  • Molecular biology
  • Immunology
  • Oncology

Breadth of Portfolio

  • Extensive library of 1,200+ organisms
  • 60+ new products launched each year
  • Products designed for use across the spectrum from high-complexity tests to point of care (POC)
  • Global distribution network

Innovation & Depth

  • Multiple BSL-2 and BSL-3 labs
  • PhD level scientists
  • Strong IP and technical expertise
  • Array of product modalities and configurations (e.g., liquid, frozen lyophilized, swab)

Compliance

  • IVD & RUO capabilities
  • ISO 13485:2016 Certified IVD and CE-IVD capability
  • FDA 21 CFR part 820
  • IVDD 98/79/EC
  • IVDR 2017/746

Trustworthiness

  • 25+ large global partners
  • High volume capabilities
  • 2 million tubes filled annually
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