Our
Services
At NeoDx Biotech Labs, developing an in-Vitro Diagnostic kit or an assay development project is backed by years of experience and an expert team of scientists. We have developed and manufactured kits that are in use by diagnostic centers across India.
What We Offer
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Our Assay Development Process Keeps Things Simple
RT-PCR Kit Development Workflow:
Phase 0: Scoping
Inquiry/Qualification
Consultation
Phase 1: Pre-Proof of Concept
Product feature comparison study and report - Predicate Kit decision
Design of Primers, probes, and synthetic controls
Preparation of Risk Management Plan
Preparation of Design and Development Plan
Phase 2: Assay Development
Proof of Concept
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Optimization of Tm in SinglePlex/MultiPlex Format
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Determination of Limit of Detection in SinglePlex/MultiPlex Format
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Testing of SinglePlex/MultiPlex assay format with biological standards
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Testing assay with true positive, true negative, and normal patient samples
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BOM Generation
Design and Development
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Design and Development Plan
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Design Input
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Design Verification form
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Design Verification Report
Verification Studies with 3 Test Batches
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Linearity and LOD determination
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Reproducibility and Repeatability Study
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Interference Study
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Cross-reactivity Study
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Stability Studies
Internal Validation Report
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Sample kit preparation and sending it to multiple validation centers
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Customer feedback report
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Assay performance reports with true positive, true negative, and normal patient samples.
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Internal Validation Report
Phase 3: Production and Manufacturing
Design Transfer
Manufacturing (Optional)
Project Completion
NeoDx Assay Development: From Test To Production
Our detail-oriented and problem-solving approach helps us tailor the product to your needs.
Reasons Why We're Different
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Flexibility: Be it a one-time product, or a combination of products, we make our expertise and knowledge work for you. We will help you develop
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Quick Turn-around Time
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Dedicated Project Manager to keep you updated on the Project process
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Data management: Our team offers you well-organized data throughout the project that you can rely on.
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Trained and Experienced R&D: To help you through the process of PCR kit Development. Our team works along with you to ensure that your product is brought to life. Know-how Expertise in every step from research, development, and manufacture, to the assembly process.
