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Therapeutic Areas & Technologies

We are highly trained scientists with deep knowledge and experience in a variety of therapeutic areas, representing the latest, innovative technologies in the medical device and diagnostics industries. Our services are tailored to fit the needs of your company and your product. We are experts at navigating complex regulatory pathways and building and implementing compliant and fit-for-purpose Quality Systems. We don't just deliver plans, we execute on those plans and deliver high quality regulatory filings, reports, policies/procedures, manuscripts, and more to lift the burden off of your team.

Therapeutic Areas

  • Oncology: solid tumors, liquid tumors, metastatic disease, tests to guide treatment decisions, monitoring tests, companion diagnostics; cfDNA, circulating tumor cells (CTC), exosomes

  • Infectious Disease: Examples: COVID-19 (coronaviruses), Ebola, Crimean-Congo Hemorrhagic Fever Virus, Lassa virus, Dengue virus, Chikungunya virus, Zika virus, Plasmodium spp. (detect pan-Plasmodium, differentiate P. falciparum), Leptospira spp., Yersinia pestis, Influenza A, Influenza B, Adenovirus, Campylobacter spp., Cryptosporidium spp., Entamoeba histolytica, Escherichia coli O157, Enterotoxigenic E. coli, Shiga-like Toxin producing E. coli, Giardia, Norovirus, Rotavirus A, Salmonella, Shigella spp., Vibrio cholerae, Bacillus anthracis, Hepatitis A/B/C, sexually transmitted infections, nosocomial infections, sepsis

  • Microbiome

  • Prenatal and Newborn Health: non-invasive prenatal testing (NIPT), newborn screening

  • Cardiology/cardiovascular: heart failure, cardiovascular disease risk

  • Hematology

  • Clinical Chemistry

  • Neurology: stroke, traumatic brain injury

  • Food and Environmental Allergy/Immunology

  • Women’s Health

  • Rare disease

  • Wellness/Lifestyle

  • Wound healing

Technologies

  • Molecular Diagnostics

  • Next-generation sequencing (NGS)

  • PCR technologies: qPCR, digital droplet PCR (ddPCR), real time PCR, reverse transcription PCR

  • Microarrays and other chip-based technologies

  • Mass spectrometry and proteomics

  • Epigenetics/Epigenomics

  • ELISA

  • Phadia-250

  • Microscopy (general staining, FISH, single-cell detection and analysis, etc)

  • Rapid diagnostic test (RDT)/Point-of-care diagnostics

  • Multiplexed detection systems (e.g. Luminex-200)

  • Hand-held detection systems/portable detection systems

  • Automation systems (e.g. liquid handlers)

  • Microfluidics

  • Proprietary systems for automation and/or detection

  • Screening, diagnostic, monitoring, therapeutic decision-making, therapeutic monitoring

  • Artificial intelligence (AI), machine learning, complex algorithms

  • Biomarker validation

  • siRNA, microRNA

  • Medical devices with software

  • Mobile medical applications

  • Clinical Decision Support Tools (CDS)

  • Cloud-based computing for medical devices and diagnostics

  • Analyte Specific Reagents (ASR)

  • Specimen collection devices

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