IVDs & Companion Diagnostics

In Vitro Diagnostics Compliance

We are a leader in addressing FDA and European IVDD (IVD Directive) regulatory and clinical trial requirements for in vitro diagnostic devices. Our experience includes work on more than 120 IVD projects, ranging from traditional IVD assays to molecular diagnostics, and IVDMIAs.

Infectious Disease

  • ELISA assay for identification of Borrelia burgdorferi (Lyme disease)
  • Point of care and laboratory diagnostics for detection of STDs
  • H. pylori breath test (analyzer and disposable)
  • PCR amplification and detection system for infectious agent
  • CD4/CD8 cell monitoring system for HIV status (analyzer and reagents)
  • Independent positive and negative controls for infectious disease testing QC/QA

Oncology

  • Genetic markers for detection of lung , colorectal, and bladder cancers
  • Companion diagnostic for colorectal cancer
  • Melanoma detection
  • Breast cancer diagnostic
  • Cervical Cancer Screening System (analyzer and reagents)
  • Immunoassays for detection of tumor-associated antigens (analyzer and reagents)

Cardiovascular

  • Cardiac inflammation-marker
  • ELISA assay for aid in diagnosing congestive heart failure (CHF)
  • Diagnostic tools for management of cardiovascular risk factors
  • Cardiac damage biomarker

Clinical Laboratory Test Systems, Reagents and Instrumentation

  • Hematology and immunology systems (analyzer, reagents and controls)
  • Point of care devices for hemoglobin testing
  • Analyzer and test system for detection of gynecological conditions
  • Automated gene expression test system
  • Molecular diagnostic test for single and multiplexed nucleic acid amplification assay
  • Specimen collection and transport swabs and media
  • DNA probe-based system for quantitative detection of specific nucleic acid sequences

Other Areas

  • Cerebral Tissue Monitoring System (probe and accessories, analyzer and reagents)
  • Endotoxin Activity Assay (analyzer and reagents)
  • Genotyping assays for smoking cessation/IVD MIA