IVD assay development
Biocult has decades of experience in IVD assay development, creating IVD products, IVD assays and diagnostic assays for the global in vitro diagnostics market. Our team of experts manages the entire assay development process, from proof of concept to final product. We deliver high-quality IVD tests that meet client needs and comply with ISO 13485 and FDA regulations, resulting in fully validated products ready for market approval.
IVD product development possibilities by Biocult
Blood tests are essential for detecting diseases and deficiencies, from Vitamin D to HIV, diabetes, and heart attacks. The devices for these tests can’t measure biomarkers on their own; they need expert IVD development.
At Biocult, we determine the right reagents, protocols, and documentation to ensure accurate results and a smooth market introduction. We create the optimal starting point, so your device and its users can do the rest.
Why choose Biocult for IVD assay development
We turn complex IVD challenges into market-ready solutions. Our expertise, commitment to quality, and regulatory know-how ensure your product reaches the market quickly, efficiently, and fully compliant.
Our portfolio in the field of IVD product development
Many years of experience have led to a large number of successes. Through our clients we have introduced numerous IVD tests to the market. The end products developed by our IVD test development facility help clinicians to diagnose and monitor diseases and deficiencies. We strive to improve the quality of life for patients, not only for now but also in the future.
Our experience across different disease areas:
Heart and vascular disease
Autoimmune diseases
Oncology
Anemia
Infectious diseases
Bone metabolic diseases
Endocrinology
Diabetes
IVD product development; how we model end products
At Biocult, we work exclusively on request, developing tests based on your specific needs rather than investing in new products ourselves. We begin with an open conversation to understand your objectives, leading to a clearly defined project scope and strong collaboration.
Once goals are set, we run a feasibility study to check the availability of critical materials, assess technical achievability, and determine realistic timelines and budgets. This transparent approach ensures you know exactly what’s possible before committing to full development.
We partner only with trusted suppliers, such as specialized antibody producers, to guarantee quality at every stage. Our proven step-by-step process has delivered consistent results for clients worldwide, helping them bring reliable IVD products to market with confidence.
Case study: The fast route to the market
Biocult assists where necessary, be it large parties with extensive IVD devices or start-ups with limited manpower. Our IVD product development is based on one principle, which guarantees an efficient yet extremely precise IVD test development. Without exception, we return everything we research and develop back to our clients. That is our promise to you.
READ OUR CUSTOMER STORY ON OPTIMIZATION
Start a Project
Let’s make something great together. Feel free to contact us for more information via the contact form.