Our Experience in In-Vitro Diagnostic Devices

Our mission is to provide best-in-class regulatory, clinical, and reimbursement services to help our clients achieve their product development and commercialization goals. We have structured our approach to navigating the regulatory and commercial landscape to align with the FDA's focus on the Total Product Life Cycle, a regulatory framework that integrates all aspects of product development. The battery of services in MCRA’s in vitro diagnostic device (IVD) portfolio therefore enables us to partner with our clients through the various stages of the innovation process, from conception, through pre-market development and FDA approval, to widespread market use and payor reimbursement. As stewards of technologies intended to diagnose or monitor a diverse array of health conditions, MCRA’s social responsibility is woven into the fabric of what we do and fuels our passion to bring the most advanced IVDs to market so that they can be used to improve the outcomes of those in need.

MCRA IVD has decades of combined experience and direct oversight from former FDA personnel from the IVD field, and are capable of taking on projects of any complexity, including (but not limited to) those within the following product areas:

  • Anemia in vitro diagnostics
  • Antimicrobial resistance marker genetic in vitro diagnostics
  • Antimicrobial susceptibility (AST) in vitro diagnostics
  • Autoimmune disorder in vitro diagnostics
  • Bacterial infection in vitro diagnostics
  • Blood clotting disorder in vitro diagnostics
  • Breath in vitro diagnostics
  • Cancer in vitro diagnostics
  • Cancer monitoring in vitro diagnostics
  • Cancer Predisposition Risk Assessment in vitro diagnostics
  • Cardiovascular disease in vitro diagnostics
  • Chemistry analyte in vitro diagnostics
  • Companion Diagnostic (CDx) in vitro diagnostics
  • Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection in vitro diagnostics
  • Diabetes in vitro diagnostics
  • Digital Pathology in vitro diagnostics
  • Drugs of abuse in vitro diagnostics
  • Fever-causing infection in vitro diagnostics
  • Food and other allergy in vitro diagnostics
  • Fungal infection in vitro diagnostics
  • Gastrointestinal bleeding in vitro diagnostics
  • Gastrointestinal pathogens in vitro diagnostics
  • Gene expression profiling in vitro diagnostics
  • Gene expression profiling test system in vitro diagnostics
  • Genetic health risk (GHR) in vitro diagnostics
  • Heavy metal in vitro diagnostics
  • Immune deficiency in vitro diagnostics
  • Immunoglobulin light chain amyloidosis in vitro diagnostics
  • Immunohistochemistry (IHC) in vitro diagnostics
  • In vitro diagnostic instrumentation
  • In vitro diagnostics supported by over the counter (OTC), point of care (POC), or CLIA waiver studies
  • Infectious disease in vitro diagnostics
  • Latent viral infection in vitro diagnostics
  • Liquid biopsy in vitro diagnostics
  • Medical Countermeasure in vitro diagnostics
  • Minimal Residual Disease (MRD)/tumor burden in vitro diagnostics
  • Neural tube defects in vitro diagnostics
  • Next generation sequencing based tumor mutation profiling in vitro diagnostics
  • Organ damage/disfunction in vitro diagnostics
  • Pharmacogenetic/Pharmacogenomic in vitro diagnostics
  • Postnatal chromosomal copy number variation detection in vitro diagnostics
  • Primary hemostatic function in vitro diagnostics
  • Respiratory pathogens in vitro diagnostics
  • Semen analysis in vitro diagnostics
  • Sepsis and septic shock prognosis in vitro diagnostics
  • Sexually transmitted disease in vitro diagnostics
  • Specimen collection devices
  • Therapeutic Drug Monitoring (TDM) in vitro diagnostics
  • Traumatic brain injury (TBI) in vitro diagnostics
  • Viral infection in vitro diagnostics
  • Women’s health in vitro diagnostic

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