Assay Development Expertise & Support
Assay Development Expertise & Support to Streamline IVD or LDT Projects
Don't let assay development challenges hinder research and development progress.
At iFyber, we utilize an analytical approach to assay development to deliver clearly quantifiable results, empowering you to make better-informed decisions. Our highly experienced, cross-functional team of multidisciplinary scientists are experienced in successfully implementing and streamlining complex IVD and LDT development projects with the speed, accuracy, and quality necessary for regulatory approvals.
Whether you need support translating your idea for an IVD from an academic lab to a commercial lab or are experiencing limited bandwidth in your internal assay development team, iFyber can help.
Discover iFyber’s Analytical Approach to Assay Development
Discover iFyber’s Analytical Approach to Assay Development
Phase 1: Assay Strategy (Startup & Knowledge, Discovery & Strategy Assessment, Assay Strategy Selection & Study Plan) Phase 2: Assay Development & Qualification (Standards & Sample Extraction, Biomaterials & Reagents, Assay Qualification) Phase 3: Assay Performance Verification & Technology Transfer (Pre-validation Study & Technology Transfer)
Sample collection, preservation, and purification
- Sample format (e.g., blood, stool, urine, saliva, among others)
- Sample collection protocol and preservation (e.g., stabilizer solution, storage conditions, vessel design, and 3D prototype)
- Sample processing and target molecule purification (e.g., inhibitor removal and target isolation
Detection mechanism selection
- Target
- Immunoassay (e.g., ELISA, LFA, ECLIA)
- Molecular assay targeting either DNA or RNA (e.g., qPCR, RT-qPCR, or LAMP)
- Readout selection (e.g., fluorescence, color, or turbidity)
- Reader selection (e.g., thermocycler, multi-mode microplate, LFA, and isothermal readers)
- Clinically relevant detection limit
- Augment Your Existing R&D Team: Work with multidisciplinary scientists who can integrate into your R&D team and are trained to see the big picture including incorporating quality and regulatory fundamentals, understanding patient and market needs, and more.
- Unmatched Expertise: Our team consists of seasoned scientists and researchers with a deep understanding of assay development. We bring years of experience to the table, ensuring that your project is in the hands of experts who have successfully tackled a wide range of challenges.
- Tailored Solutions: We recognize that assay development is not a one-size-fits-all solution. That's why we work closely with you to understand your specific needs and objectives. Whether you require biochemical, cell-based, or molecular assays, we craft customized solutions that align perfectly with your research goals.
- Clear Development Path: Our process involves clear communication of the status of project phases, with clear go/no-go milestones. While we work out the details, this is your assay - so we design, test, verify, and validate with that in mind.
Assay Development Services:
Assay Development Service Sheet Downloads:
Value-Driven Support with Our PODS (People Organization Dedication Scale) Model:
- Added Expertise & Support: PODS integrates into your Molecular Testing Labs team – extending your R&D team.
- Ongoing Communication: Receive frequent communication and weekly meetings between the PODS and internal teams where we review tasks, data, and provide strategic advice.
- Real-time Project Pivots: PODS respond to mid-study data results to optimize outcomes and shorten project timeframes.
- Dedicated Technical Team: Provides the expertise needed for a specific project task/phase without the added hiring commitment.
- Scale More Efficiently: PODS can enable internal molecular testing lab staff can focus on other essential activities to help you scale quickly.