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Labcorp Message (as of July 21, 4:00 p.m. ET)

  • All Labcorp core systems impacted by the CrowdStrike issues are currently back online.
  • Some of our patient service centers and in-office labs may be experiencing technical issues with retrieving orders.
  • We are working hard to resolve this issue.
  • If you have a copy of your order, this will help expedite the process.
  • We appreciate your patience as we work to restore business operations.

Bespoke scientific expertise to expedite your gene therapy program

Gene therapies

Unique in vivo models, complex methods and routes of administration, to streamline your development
  • Therapeutic area expertise for indications including: neurology, cardiovascular disease, ophthalmology, immunology and more

  • Custom assay support for preclinical, biomarker-driven clinical trial testing and commercialization of your potential companion diagnostic

  • Robust global laboratory experience supporting of 7 FDA-approved gene replacement therapies


A partner for your gene therapy testing needs—wherever you are in development

Whether you’re developing a viral vector-based therapy, such as an adeno-associated virus or lentivirus product, or applying gene editing technologies such as CRISPR/cas9, we’re here to offer you the type of support you need—when you need it—so you can reach your development goals on time and within budget.

Pharmacodynamic response/efficacy/research and development of novel delivery modalities

  • Longitudinal, in vivo imaging in rodents (IVIS)In-life, in vivo imaging in rodents (IVIS)
  • Variety of targeted surgical techniques, including MRI-guided stereotaxic surgery
  • IHC, ELISA
  • Gene expression by RT-qPCR, NanoString

Toxicology and safety assessment

  • GLP compliant in small- and large-animal models
  • GLP formulation, dose analysis and administration, including delivery device compatibility testing
  • Biodistribution and persistence qPCR or ddPCR, RT-qPCR, IHC, ELISA, neutralizing antibody (nAb), total antibody (tAb)
  • Histopathology and IHC; board-certified clinical and anatomic pathologists
  • Cytokine/chemokine analysis: multiplexed immunoassays
  • Clinical pathology (e.g., clinical chemistry, hematology, urinalysis)
  • Toxicology assessment for the projected Phase I doses

Critical quality attributes

  • Genomic and capsid titer
  • Potency
  • Safety and replication competent vector
  • Purity and impurities
  • Identity
  • Stability

Patient selection/predictive biomarkers

  • Clinical biomarkers (Luminex, MSD, Quanterix, ELISA)
  • Preexisting immunity by ELISA, cell-based assays, companion diagnostics
  • Genomics (including NGS)

Safety

  • Shedding by PCR
  • Circulating biomarkers (using Luminex, MSD, Quanterix, ELISA, etc.)
  • Immunogenicity: ELISpot analysis to vector and transgene
  • ADA to vector and transgene
  • Vector site integration

Target identification and patient selection/predictive biomarkers

  • Gene expression (NanoString, NGS, PCR, single-cell sequencing)
  • Multiplex cytokine and chemokine assays (MSD, Luminex, Quanterix)
  • IHC
  • Flow cytometry

LET'S START THE CONVERSATION

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