In Vitro Diagnostics (IVD)
Assay development solutions to streamline IVD research and development.
At iFyber, we utilize an analytical approach to assay development to deliver quantifiable results, empowering you to make better-informed decisions. Our highly experienced, cross-functional team of multidisciplinary scientists is experienced in successfully implementing and streamlining complex in vitro diagnostics (IVD) and laboratory developed test (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.
Assay Development Services for In Vitro Diagnostics
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
Ready to elevate your research? Contact us to discuss how we can support your in vitro diagnostic (IVD) project.
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)
View our assay development process sheet for more information on our approach, the goals and deliverables of each phase, and an overview of our PODS program.
Explore Our Resources:
Nucleic Acid-Based Molecular Assay
iFyber has the experience and the expertise to develop and optimize nucleic acid-based molecular assays for monitoring gene expression and the detection of nucleic acid targets.
Lateral Flow Assay Development
iFyber offers Lateral Flow Assay (LFA) feasibility, characterization, and development services for clinical diagnostics applications. Our molecular biology and protein biochemistry team can help optimize your LFA assay to meet your development goals and timelines.
Choosing between Immunoassays and Molecular Assays
Immunoassays and molecular assays are two distinct diagnostic testing methods used in healthcare and research, each with unique characteristics and applications. Discover key considerations when selecting an assay during the early stages of development.