PURE Innovation Biotech
Home · Diagnostics

Diagnostics

Molecular diagnostics from concept to validation with robust analytical performance.

Diagnostics

Overview

We combine automation, computational design, and rigorous documentation to shorten research cycles and increase reproducibility.

Quality

GxP‑aligned methods and change control ready for scale.

Security

Project data isolated with audited access.

Capabilities

Assay Design

qPCR/dPCR, CRISPR, and isothermal formats.

Sample Prep

Extraction workflows, swabs to plasma.

Controls & Standards

Internal controls, LoD, and traceability.

Verification & Validation

Accuracy, precision, inclusivity/exclusivity panels.

Clinical Studies

IRB support, data capture, and reporting.

Regulatory Support

Documentation aligned with CLIA/IVD pathways.

Workflow

Use‑Case & Targets
Intended use, matrices, analytical targets defined.
Design & Prototyping
Primer/probe selection, multiplexing strategy.
Analytical Validation
LoD/LoQ, specificity, linearity, interference.
Stability & Packaging
Real‑time/accelerated; transport ruggedness.
Clinical Performance
Study design, data management, and reporting.
Transfer
Tech transfer to partners or in‑house scale‑up.

Platforms & Equipment

qPCR & dPCR

Validated thermocyclers and analysis pipelines.

NGS Support

Library prep and bioinformatics for targeted panels.

Quality Systems

Traceable documentation & lot release criteria.

Contact

Get in touch

We’d love to hear about your program.

Email: pibbiotech@gmail.com
HQ: Flat 701, 11 Florinis Street, 7th Floor, 1065 Nicosia, Cyprus

Collaborations

Partner with us for discovery, diagnostics, or manufacturing.

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