The development and manufacturing of assays can be a daunting process. In addition to assay performance considerations, there are time, regulatory, labor, and cost considerations that come into play. At IVD Technologies, we understand that development and manufacturing is best when it is efficient. We work with our clients to tailor a product to their specific requirements. Our profile includes the development and manufacturing of specific assays for reference laboratories, universities, veterinarians, and medical centers in the United States and around the world. Whether it’s the development of novel assays or the development of existing assays for in-house use, we’re here as your partner in the realization of your ideas.
In developing a diagnostic product, some of the things we consider are the following:
Assay Performance— Sensitivity, specificity, and reproducibility of assays are tailored to the specific requirements of our customers.
Regulatory Requirements— Our QA team is experienced in submitting for FDA product clearing and USDA product licensing. Development and manufacturing procedures are in accordance to ISO requirements.
Simplicity— Minimizing unnecessary steps in an assay protocol saves time, labor, and cost; allowing for results to be attained faster. We take into consideration all of the steps that allow for a product that is simple, quick, and precise.