Some of the world’s largest suppliers of in vitro diagnostic (IVD) products rely on us as their OEM and contract manufacturing partner. With over 35 years of experience, customers count on us for quality, compliance, and reliability.
We specialize in:
We also have expertise in identifying and developing novel biomarker assays that serve unmet clinical needs and in developing niche diagnostics assays including, but not limited to, drugs of abuse testing (DAT), therapeutic drug monitoring (TDM), immunosuppressant drug monitoring (ISD), and companion diagnostic tests.
We have a global manufacturing footprint with multiple centers of manufacturing and development excellence. All current contract manufacturing facilities are compliant with FDA, international, and ISO guidelines.
Video: Enabling partner innovation and productivity through custom solutions for the In vitro diagnostics (IVD) market.
We have a wide range of capabilities, including large volume liquid formulation and filling, lyophilization, biomarker assay development, antibody production, development and validation of drugs of abuse tests, therapeutic drug monitoring assays, clinical chemistry reagents, calibrators and controls, as well as designing and developing clinical chemistry, immunoassay, and lab automation instrumentation.
Our global manufacturing footprint has multiple centers of excellence for development and manufacturing. All current sites are compliant with FDA and international regulations and have ISO 13485 certification.
Centers of excellence
Middletown, Virginia—contract manufacturing and clinical chemistry reagents
Fremont, California—specialty diagnostics products
Hennigsdorf, Germany and Nimes, France—novel biomarkers
Vantaa and Joensuu, Finland—instrumentation and automation
China and Eastern Europe—expansions on-going to provide diagnostic reagent manufacture
Our Regulatory and Quality Systems are a cornerstone for our contract manufacturing services. We understand that our customers come to us and stay with us due to the strength and robustness of these systems and processes.
Final product and release testing
Validated assay applications for various diagnostics instrument platforms
We are proud to be able to offer our capabilities to fulfill Thermo Fisher Scientific's mission: to enable our customers to make the world healthier, cleaner and safer.
For more information about our clinical diagnostics services, contact us via phone or email.
8365 Valley Pike
Middletown, VA 22645
Phone: +1 800-528-0494
46500 Kato Road
Fremont, CA 94538
Phone: +1 800-232-3342
Phone: +49 (0)3302 883 753
Ratastie 2, 01620
Phone: +358 10 329 200