IVD Technologies/Platforms

Goldbug Strategies has extensive knowledge and experience of regulatory requirements and compliance obligations across a vast range of in vitro diagnostic medical devices. With our demonstrated track record of regulatory success and comprehensive knowledge of IVD requirements, our team of former FDAers and current industry experts deliver best-in-class regulatory and scientific expertise and critical insight needed to enable our clients to achieve their business objectives and optimize success.

Our experts have worked extensively across industries in the precision medicine space possessing deep understanding of the entire product life cycle to ensure the safety and effectiveness. By implementing proactive solutions through our integrated approach at various phases spanning the complete life cycle of product development and commercialization, we offer full-service quality support to achieve client satisfaction within the complex IVD space covering the following diagnostic products:

Molecular Biomarkers (NGS)
  • Liquid and tissue biopsy CDx
  • Tumor profiling
  • Minimal residual disease (MRD)
  • Multi-cancer early detection (MCED)
  • Cancer screening
  • Whole exome sequencing
  • Single-cell genomics
Molecular Biomarkers (Others)
  • PCR (Real-time and Digital)
  • Genetic health risk
  • Pharmacogenomic tests
  • Pharmacogenetic tests
  • Genotyping arrays
  • Genetic predisposition
  • Gene expression microarrays/Gene expression profiling
  • Chromosomal microarrays
Protein-Based Biomarkers
  • Immunoassays
  • Immunohistochemistry (IHC)
  • Mass spectrometry (coupled with liquid chromatography (LC-MS))
  • Single-cell proteomics
  • Protein microarrays (e.g., aptamers)
Cell-Based Biomarkers
  • Flow cytometry
  • Fluorescence in situ hybridization (FISH)
  • Chromogenic in situ hybridization (CISH)
  • Circulating tumor cell (CTC) detection
Other Diagnostics
  • In vitro diagnostic instruments, platforms, reagents, and imaging systems
  • Breath tests (Mass spectrometry coupled with gas chromatography (GC-MS) for volatile organic compounds)
  • Biodosimetry
  • Digital pathology

IVD Therapeutic Areas

Goldbug Strategies has significant regulatory experience in IVD development for various clinical uses across multiple therapeutic areas to support client needs.

Backed up by our scientific and clinical subject matter experts, the Goldbug team provides pragmatic and practical regulatory guidance and strategic advice to meet your objectives for CDx development for targeted therapeutic products within the precision medicine field and IVD development for various clinical uses in different disease areas:

  • Diagnosis
  • Screening
  • Monitoring
  • Therapy selection
  • Therapeutic response prediction
  • Prognosis
  • Early detection
  • Tumor burden/MRD
Infectious Diseases
  • Covid-19
  • Sexually Transmitted Diseases
  • Respiratory Pathogens
  • Monkeypox
  • Other Viral and Bacterial Diseases
Women's Health
  • Endometriosis
  • Newborn screening
  • Non-invasive prenatal testing
  • Metabolism disorders
  • Liver diseases
  • Renal diseases
  • Diabetes
  • Clinical chemistry
  • Neurological diseases
  • Neurodegenerative disorders
  • Toxicology
  • Hematology
  • Immunology and Inflammation
  • Gene and cell therapy
  • Genetic diseases

Clinical Use Settings

The intended use setting for a diagnostic device is one of the critical factors contemplated when developing regulatory strategy as it drives commercialization “rail guards” for the product. FDA imposes different levels of regulatory requirements and oversight for each intended clinical use setting.

The Goldbug team has the leadership and expertise to provide strategic directions for specialized needs to get safe and effective products into the market. Our due diligence, tactical advice, and related services support the breadth of sophisticated IVD technologies within various market segments covering the following clinical use settings:

Market Segments
  • Direct to consumer (DTC) testing
  • Point of care (PoC) testing
  • Over the counter (OTC) testing
  • Central lab (single site) IVD assays
  • Laboratory developed tests (LDT)
  • Distributed IVD kit model
  • At-home testing
  • Home use specimen collection kits

Digital Health

Digital health tools and technologies have become increasingly vital and integral to patient care including clinical workflows. Digital health technologies (DHTs) can cover medical devices, wearable consumer products, patient-led registries, mobile applications and software.

They encompass a wide spectrum of applications in general wellness, personalized medicine, telemedicine and telehealth, health information technology and mobile health categories. With the rapidly changing landscape of digital health technologies, companies often find themselves struggling to successfully navigate evolving FDA regulations.

The Goldbug team helps clients to drive their success and achieve their goals by providing regulatory guidance across the digital health landscape through navigating the complex and ever-evolving regulatory environment for the following uses:

Digital Health Tools
  • Software as a medical device (SaMD)
  • Software in a medical device (SiMD)
  • Mobile Medical Applications (MMA) Clinical Decision Software
  • Wearable devices
  • DHTs for remote data acquisition in clinical studies
  • Artifical Inteligence/Machine Learning (AI/ML)