Biomarker Assay Development for Biopharma
During drug development, biomarkers serve as indispensable tools for understanding disease biology, target identification, evaluating drug efficacy, and guiding treatment decisions, preferably as early as possible. In addition, they can be used as important tools for internal decision-making on the course of clinical development programs.
At Future Diagnostics, we offer a spectrum of Biomarker Assay Development Services tailored to the needs of the biopharma industry, spanning from initial proof-of-concept to the development of regulatory-grade companion diagnostics.
An overview of our services:
1. Biomarker assay development and validation:
We develop innovative biochemical and molecular assays to detect a wide array of biomarkers, including proteins, enzymes, hormones and nucleic acids. Assay development can be performed de novo or we can validate existing assays in a fit-for-purpose manner. Our flexible approach ensures that your assays are precisely aligned with your research or clinical goals.
2. Improvement of existing assays
Struggling with existing assays that don’t quite meet your clinical or regulatory needs? With over 25 years of assay development expertise, our services are designed to tackle challenges head-on and enhance the performance of your assays for robust and impactful results.
3. Platform selection and transfer
Choosing the right platform for your assays and transferring them seamlessly is pivotal for success in assay development. Once the platform is selected, we facilitate transfer of assays to the chosen platform, such as our in-house automated clinical chemistry analyzers. All this while ensuring robust validation, optimization, and qualification to maintain assay performance and reliability.
4. Complementary and Companion Diagnostics (CDx) development
Building on our extensive experience in the IVD industry, our team designs and optimizes your CDx assays that accurately and reliably detect biomarkers in patient samples. The result is a regulatory-grade product that is ready for market.
5. We are here to help!
Do you have specific needs in the development of your biomarker assays? Custom requests that require a flexible and solution-oriented approach? Do not hesitate to contact us and start the conversation on maximizing output of your assay development to optimally guide your clinical trials!
Why Future Diagnostics as your Biomarker Assay Development Partner?
1. Experts in assay development:
With more than 25 years of expertise in advanced assay development, working with a large group of both emerging and large IVD and pharma companies, we are the perfect partner to support your needs in biomarker assays and the associated challenges.
2. Cutting-edge and customized technology solutions
With a commitment to advancing precision medicine and improving patient outcomes, Future Diagnostics has continually embraced novel approaches for assay development. We are not bound to specific platforms or detection techniques and are highly adaptive to the specific needs of our partners. Single- or multiplex? Fluorescence, luminescence or other? No problem! We understand that each project is unique with highly specific objectives and at Future Diagnostics we approach each project this way with full focus.
3. Quality Assurance and Regulatory Compliance
Future Diagnostics maintains stringent quality management systems and adheres to regulatory guidelines to ensure the reliability, reproducibility, and regulatory compliance of its assay development activities. With an ISO13485-certified quality management system and FDA-registered manufacturing facility, our partners can have confidence in the quality and integrity of development projects executed by Future Diagnostics.
4. The benefits of outsourcing
Outsourcing of biomarker assay development projects to a highly experienced organization like Future Diagnostics yields numerous benefits. This includes cost-efficiency and short turnaround times for assay optimization, streamlining your drug development program and ultimately increasing drug approval rates and shortening time-to-market.
5. Collaborative and transparent partnership approach:
We work closely with you as our partner to optimally understand your specific requirements, internal objectives and timelines. By open communication and transparent project management, we strive to build long-term relationships based on trust and shared success.
Experience across different disease areas
We have experience across a wide range of therapeutic areas, including:
- Oncology
- Hematology
- Neurology/CNS, including neurodegenerative diseases
- Cardiovascular
- Infectious diseases
- Immunology
- Gastroenterology
- Endocrinology
- Rare diseases
- Musculoskeletal
- Hepatology
- Respiratory
- Diabetes
Partner with us in navigating the landscape of biomarker assay development. Contact Future Diagnostics to learn more about our services and how we can collaborate to advance your clinical objectives.
Would you like to find out more about our services and how we can collaborate to advance your clinical objectives?
We’d love to hear from you!