MOLECULAR RAW MATERIALS FOR IVD ASSAYS

Given the rapid and dynamic nature of disease outbreaks, securing precision reagents from a robust supply chain with supporting compliance documentation is key for the continued success and growth of in vitro diagnostics. Additionally, reliably sourced, contamination-free molecular materials for use in diagnostic assays are increasingly in high demand as concerns for false positive/negative test results increase.

Our goal is to solve the toughest problems in life science with expertise, passion, and commitment, by providing scientists and engineers with best-in-class lab materials, molecular technologies and services. Leveraging our extensive diagnostic assay development experience and worldwide manufacturing, we are excited to offer molecular raw materials suitable for use in the development and manufacturing of diagnostic assays. Our foundational molecular raw materials portfolio will be sure to support your needs with many products in the assay development workflow, complete with QA, and audit-ready documentation.

To be informed of our latest molecular raw materials product releases, or if you have specific immediate needs for support, please contact us.

MOLECULAR RAW MATERIALS IN A CONSTANTLY EVOLVING IVD REGULATORY LANDSCAPE

To prepare for new guidance directives like the EU IVDR, diagnostics manufacturers must not only secure raw materials that work in their assay but also be able to back up their quality claims with audit-ready documentation. As an industry leader and partner to diagnostic manufacturers large and small globally, we understand the need to adapt quickly to changes in IVD development manufacturing regulations and offer a molecular raw materials product portfolio with full technical support and quality documentation. The distinguishing factor of the products in this portfolio is the M-Clarity™ Level.

M-CLARITY LEVEL FOR IVD RAW MATERIALS

Industry-driven regulations require that products of higher criticality or those used in highly-regulated industries, such as pharmaceutical or in vitro diagnostics manufacturing, need enhanced supplier quality support. To further support manufacturers, we launched the M-Clarity™ Quality Program to ensure that these crucial technical and documentation needs are met throughout the different focus areas of Life Science.

The MQ levels of the M-Clarity™ Program provide transparency so that you can choose, with confidence, suitable products that meet your needs with respect to quality and regulatory compliance, transparency, and change notification.

The Molecular Raw Materials portfolio contains a broad range of key products with MQ300-MQ400 quality levels. The table below outlines the quality attributes and service our customers can expect to receive from our products at these M-Clarity levels:

MOLECULAR DIAGNOSTICS REAGENTS FOR A CHANGING WORLD

In bringing together and supporting these quality molecular reagents our goal is to provide molecular diagnostic assay developers and manufacturers the materials and support they need for commercial success in a rapidly changing global market. We will continue to add new molecular dx materials with quality documentation on a regular basis as they pass our extensive validation process.