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In Vitro Diagnostics Platform

Advancing
Diagnostics.
Impacting Lives.

Reliable diagnostics built with disciplined science. Altdia develops integrated IVD platforms — from R&D through regulatory clearance — with end-to-end engineering expertise.

AE-CLIATR-FIA BiochemistryMolecular Dx
End-to-End Capability

"Quality-led, science-focused execution across the full IVD value chain — from assay concept to clinical use."

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Chemiluminescence Immunoassay
Time-Resolved Fluorescence
Clinical Biochemistry
Molecular Diagnostics
Reagent Development
Analytical Validation
Regulatory Documentation
Assay Engineering
Chemiluminescence Immunoassay
Time-Resolved Fluorescence
Clinical Biochemistry
Molecular Diagnostics
Reagent Development
Analytical Validation
Regulatory Documentation
Assay Engineering
Who We Are

Science-driven diagnostics for a healthier world

Altdia is an in vitro diagnostics company developing integrated platforms with rigorous science at the core. We build systems that healthcare providers and laboratories can trust.

🔬

In-House R&D

Complete reagent and detection molecule engineering capability, from raw materials to finished product.

🏭

Quality Manufacturing

Scalable, quality-controlled production processes with lot-to-lot consistency.

📋

Regulatory Ready

Full documentation support for CE-IVD, CDSCO, and global market authorizations.

🚚

End-to-End Distribution

Integrated supply chain and logistics management from production to delivery.

"Quality-led. Science-focused. Patient-centered."

Our end-to-end operating framework covers every stage — R&D, manufacturing, quality assurance, regulatory documentation, and distribution.

4+
Platforms
E2E
Framework
IVD
Focused
Advancing Diagnostics. Impacting Lives. ✦
Technology Platforms

Integrated diagnostic platforms

Purpose-built technology stacks delivering sensitivity, specificity, and clinical reliability across modalities.

TR-FIA
Immunoassay Platform

Time-Resolved Fluorescence Immunoassay

Lanthanide-based fluorescence technology delivering superior sensitivity with extended label stability — ideal for low-abundance biomarker detection.

  • Lanthanide chelate labels
  • Extended signal lifetime
  • Low-abundance biomarker detection
BCHEM
Biochemistry Platform

Clinical Biochemistry

Enzymatic and colorimetric assay platforms for routine and specialized biochemistry panels. Optimized for accuracy and precision across clinical chemistry analyzers.

  • Enzymatic & colorimetric methods
  • Routine and specialty panels
  • Multi-analyzer compatible
MDx
Molecular Platform

Molecular Diagnostics

Nucleic acid amplification-based platforms for infectious disease, oncology, and genetic testing. Combining speed, accuracy, and multiplexing capability.

  • PCR & isothermal amplification
  • Multiplex detection
  • Infectious disease panels
  • Oncology markers
How We Work

End-to-end operating framework

A disciplined, stage-gated process that ensures quality at every step — from concept to clinical deployment.

01

R&D

Assay concept, detection molecule engineering, and feasibility studies

02

Formulation

Reagent development, optimization, and stability studies

03

Validation

Analytical validation, method comparison, and performance benchmarking

04

Regulatory

Technical documentation, submissions, and compliance management

05

Distribution

Quality-assured manufacturing, supply chain, and market release

Why Altdia

Built on rigor.
Trusted for results.

What differentiates a good diagnostic from a great one is the discipline behind it.

⚗️

In-House Reagent Development

Complete control over chemistry — from raw materials to finished reagent — ensuring consistency and traceability at every batch.

🎯

Analytical Validation Expertise

Structured validation planning aligned with CLSI, ISO 15189, and global regulatory requirements.

📊

Quality-Led Culture

Quality is embedded in every design decision — from assay architecture to documentation.

🌍

Multi-Market Regulatory Readiness

Technical files structured for CE-IVD, CDSCO, and emerging market submissions from day one.

🔬
Science
First

Every platform decision is driven by evidence and analytical data — not assumption.

IVD
Specialized Focus
4
Platforms
E2E
Full-Stack
QMS
ISO-Aligned
Technical Capabilities

Deep expertise across the IVD value chain

Our team combines scientific depth with engineering precision across every layer of diagnostic development.

⚗️

Assay Engineering

Designing and optimizing immunoassay and molecular assay architectures for maximum clinical performance across target analytes.

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Detection Molecule Engineering

In-house antibody characterization, conjugation chemistry, and label development for superior signal generation and specificity.

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Reagent Formulation

Precision formulation science ensuring reagent stability, lot-to-lot consistency, and shelf-life performance across storage conditions.

📋

Analytical Validation

Comprehensive validation plans covering precision, accuracy, linearity, interference, and clinical performance per global standards.

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Regulatory Documentation

Technical file assembly, risk management, and regulatory strategy for CE-IVD, CDSCO, and other market authorizations.

🏭

Scalable Manufacturing

Quality-controlled production systems designed for reliable scale-up from development quantities to commercial volumes.

Ready to partner on your next diagnostic platform?

Whether you're developing a new assay or scaling an existing one, Altdia brings the science, systems, and expertise to take it forward.

Careers

Build the future of diagnostics

We're looking for scientists, engineers, and regulatory professionals who want to do meaningful work at the frontier of IVD.

🧬

Scientific & Technical Roles

R&D scientists, assay engineers, formulation chemists

📋

Regulatory & Quality

RA specialists, QA/QC professionals, validation experts

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Business & Operations

Commercial, supply chain, and operational roles

Why Join Altdia

Meaningful Impact

Your work directly influences diagnostic quality for patients around the world.

End-to-End Exposure

Work across the full IVD development cycle — rare in the diagnostics industry.

Science-Led Culture

Decisions are driven by evidence. Ideas are welcomed at every level.

Growth Opportunity

Join a growing platform company with a clear roadmap and ambitious goals.