Human Diagnostics

Expertise in Diagnostic Assay Development for Infectious Diseases, Biomarkers, and More

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Gila Bioscience Specializes in Diagnostic
Assay Development

For human health  delivering rapid, reliable, and regulatory-ready testing solutions across a wide range of clinical applications. Our decades of experience in point-of-care assay development have helped launch FDA-cleared diagnostics that are still in market today.

From infectious disease to biomarker-based screening, we build assays designed for accuracy, ease of use, and commercial scalability. Whether you’re looking to develop a lateral flow, ELISA, or molecular test, Gila offers end-to-end support from concept to regulatory clearance.

Gila Bioscience Specializes in Diagnostic<br /> Assay Development

End-to-End Support for Diagnostics Development

We provide complete support for every stage of diagnostics development.

End-to-End Support for CDx Development

Biomarker & Assay Feasibility

Reagent design and optimization.

Matrix compatibility studies.

Early-stage assay prototyping.

Analytical & Clinical Validation

Sensitivity, specificity, and reproducibility evaluations.

Usability and robustness for clinical trial integration.

Stability studies and device optimization.

Regulatory Pathway Navigation

Support for FDA, EMA, and global submissions.

Alignment with 21 CFR Part 820 and ISO 13485 QMS.

Documentation for EUA, 510(k), or PMA.

Manufacturing & Scale-Up

GMP-compatible pilot and full-scale manufacturing.

Custom reagent formulation and kitting.

Batch release testing and ongoing stability programs.

Diagnostic Areas of Expertise

Infectious Diseases

Including bacterial, viral, parasitic, and fungal pathogens.

Therapeutic Drug Monitoring (TDM)

For antiretrovirals and chronic condition medications.

Biomarker Screening

Supporting early detection of cancer, inflammation, and radiation exposure.

Serological Testing

Detecting immune response to viral infections and vaccinations.

Emerging Diseases & Biothreats

Rapid assays developed in response to global health threats and public health needs.

Sample Types Supported

We design diagnostic assays for a wide variety of biological matrices. Each matrix presents unique challenges – we engineer solutions that deliver accurate and reproducible results.

Whole Blood

Serum

Plasma

Saliva

Urine

Feces

Sputum

Nasal Swabs

Throat Swabs

Cerebro-spinal Fluid

Representative Assays We’ve Helped Develop

  • Strep A
  • RSV
  • Influenza A/B
  • Adenovirus
  • Legionella
  • Norovirus
  • Rotavirus
  • HIV Serology
  • Malaria HRPII & LDH
  • HSV, VZV, CMV Serology
  • Clostridium difficile (Toxins A & B)
  • Human Metapneumovirus
  • Lactoferrin
  • SARS-CoV-2 Antigen and Serology
  • Radiation Biomarkers
  • Cancer Screening Biomarkers
  • Giardia
  • Cryptosporidium

Human Diagnostics with Gila Bioscience

Human Diagnostics with Gila Bioscience

IVD-Focused Expertise

Over 45 years of combined experience in human assay development.

Track Record of FDA Success

Multiple assays cleared and commercialized through FDA and IVDR pathways.

Speed & Scalability

Agile development processes that support fast prototyping and future manufacturing transfer.

Regulatory-Ready from Day One

Built-in design controls, documentation, and quality compliance for global submissions.

From Concept to Market-Ready Kits

Our track record includes supporting human diagnostics innovation.

Risk analysis and verification protocols

Process validation and stability studies

Design control documentation

Let’s Advance Your Diagnostic Innovation

Whether you’re developing a novel biomarker assay, an FDA-cleared infectious disease test, or a next-generation lateral flow device, Gila Bioscience is your dedicated partner in diagnostic assay development.

(833) 710-0912

info@gilabioscience.com