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Molecular Diagnostic Case Study

Molecular Diagnostic Case Study

Fast Track to Early Detection

NEED

A molecular diagnostic company with in vitro diagnostics (IVD) technology for rapid and early detection of a common form of cancer approached VWR to manufacture and support commercial development of several buffer reagents and solutions used in an IVD test kit.

SOLUTION

The company needed a long-term partner to supply the products needed for clinical trial testing, all the way through initial production for release to market, on a rapid time scale and with extreme attention to quality, regulatory compliance, and custom product validations. VWR Custom Manufacturing Services answered the call with its diverse capabilities, including aseptic production, hazardous material production, and automated fill & finish.

RESULTS

The samples yielded positive results and the company successfully completed clinical trials for final approval of the IVD test kit to the market. VWR continues to support the company's commercial activities by meeting the production needs for rapid growth in the market.