NeoDx Assay Development:
Ensuring Accurate Results
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.
Whether you want to develop a Lateral Flow Assay based Product or a Real Time PCR based Diagnostic Kit, our products include high-performance formulations ensuring a quicker path to commercialization.
We follow Phase-gated and regulated processes for developing products.
Lateral Flow Assay (LFA), also known as Lateral flow immunochromatographic Assay (LFIA) or a Lateral Flow Device (LFD), is widely used as a point of care device/Point of care test (PoCT/PoCD).
LFAs help in visually confirming the presence or absence of a target analyte (for example Biomarkers, hormones, or pathogens) in the liquid sample. LFAs that have an antigen as a target analyte is generally referred to as Rapid Antigen Tests or RATs.
As a PoCT/PoCD, Lateral Flow Assays eliminate the need for costly and specialized equipment; and can provide results in under thirty minutes making them simple and economical.
Real Time Polymerase Chain Reaction, is a molecular biology technique that monitors the amplification of a targeted DNA Molecule in real-time (during a PCR run) and not at its end (as in conventional PCR).
Generally abbreviated as RT-PCR, Real Time PCR finds applications in both diagnostic and research. In Diagnostics, Real-time PCR is used to rapidly detect nucleic acids that are of diagnostic value, for instance, for the detection of infectious diseases, cancer, or genetic abnormalities.
The application of Real-time PCR has fundamentally changed the diagnostic landscape and is considered to be the “Gold Standard” in disease diagnostics, and is employed as a tool to detect existing as well as emerging diseases like the Coronavirus (SARS-CoV-2).
At NeoDx Biotech Labs, we simplify the Assay Development process for Lateral Flow Assays (LFA) and Real Time PCR kits for In-Vitro Diagnostics.
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
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.
