Assay Development Services & Expertise
Assay Development Services & Expertise 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
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
Assay Development Services:
Service Sheet Downloads:
- 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.
Value-Driven Support with Our PODS (People Organization Dedication Scale) Model:
Added Experties & Support Ongoing Communication Real-time Project Pivots Dedicated Technical Team Scale More Efficiently
Added Experties & Support
PODS integrates into your molecular testing lab team - augmenting and expanding your existing R&D team.
Ongoing Communication
Real-time Project Pivots
Dedicated Technical Team
Scale More Efficiently