Capabilities
We support diverse sequencing and genomic technologies for use in IVD diagnostics development in the fields of oncology, infectious diseases, and heritable diseases. If you are looking for a specific technology not found below, please contact us
Next Generation Sequencing
Roche
Avenio Targeted Panel: This allows for the analysis of 17 oncology-related genes, including those published in the National Comprehensive Cancer Network (NCCN) guidelines.
Avenio Expanded Panel: The expanded panel includes the 17 NCCN guideline related genes as well as 60 additional biomarkers that are currently being analyzed in oncology clinical trials to determine their utility
Avenio Surveillance Panel: True to its name the surveillance panel has been optimized with the guideline genes as well as 180 additional genes to allow for longitudinal analysis that monitors tumor burden (TMB) and minimal residual disease (MRD).
Illumina
TruSight Oncology (TSO) 500 panel: The TSO panel is designed for the SNV, Indel, CNV and fusion analysis of 523 oncology related genes making it a great biomarker discovery tool. It also analyzes Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI).
Quantitative Real-Time PCR (qRTPCR)
- Gene expression
- Copy number variation
- Absolute copy number variation (CNV)
- Confirmatory testing
- SNP genotyping and allelic discrimination
- Methylation analysis (CpG)
- Pathogen detection and quality control
- Circulating tumor DNA (ctDNA) and cell-free DNA (cfDNA) detection in liquid biopsy
- Rare mutation and allelic discrimination
- Low-abundance transcript detection
- Vector copy number (copies/genome)
- Viral titer (copies/mL)
Custom Laboratory Services
- Full Commercial Assay Development
- Clinical Trial assays (CTA) under CLIA
- Proprietary Validation and Testing Services
- Site Specific 510(k) and PMA
- Full Stack Clinical licensure, buildout and accreditation
Full Commercial Development
ResearchDx can develop, validate and launch your custom assay technology in our fully approved and accredited facility. We can additionally assist with MolDx submissions, billing and sale of your test from our CLIA licensed, CAP accredited Facility.
CTA Assay Development
Need a custom assay for your clinical Trial or CDx development? RDx can provide custom development, validation of the assay, and full clinical trial sample collection, testing, and project management services
Proprietary Validation and Testing
Still in stealth mode, or need an assay validated for use by only your organization. No problem, RDx can setup completely confidential workflows, ensuring absolute privacy.
Site specific 510(k) and PMA
RDx has extensive experience in submitting site-specific IVDs. We can provide full-service submissions at your site or ours.
Contract Laboratory Development
Need your own commercial facility?
RDx can provide a “Full stack” contracted service, providing you with your own CLIA-approved CAP-accredited licensed facility maintained by RDx personnel and located either at your site or ours.
Absolute Quantification
ddPCR
- Rare sequence and mutation detection
- NGS pre- and post-run validation
- Sensitive copy number variation (CNV) detection
- Viral titer (copies/mL)Qualification of Nucleic acids
- Single-cell analysis
- Gene editing event detection
- Gene expression and miRNA analysis
- Liquid biopsy: cfDNA
- Biodistribution in including Gene therapy vectors
FISH: RNA or DNA
- All commercially available probes
- Custom probe design and manufacture
- RUO, IUO, and GMP manufacture
Cell & Tissue Methodologies
We support anatomic pathology, liquid cell sorting and enrichment, and cytogenetics techniques deployed for various applications, particularly oncology.
Cell Sorting & Enrichment
- Fluorescence-Activated Cell Sorting (FACS)
- Individual tumor and stromal cell recovery from FFPE and CTC samples
Flow Cytometry
- Commercial and custom flow panel for hematology and lymphoid malignancies
- Biomarker detection
- Cell-profiling
- Immunophenotyping
- Receptor Occupancy Assay
- Rare Cell Detection and Quantification
- Intracellular Cytokine Staining (ICS)
- Phosphoflow Assay
- CAR-T Characterization
Cell Culture
- 100+ characterized control cell lines for oncology applications
- FFPE control cell block preparation
- Control DNA/RNA preparation
Anatomic Pathology
- Metasystems Metafer imaging station
- Carl Zeiss Auto Imager
- IHC, H&E on FFPE and Frozen tissue
- Pathology review and macro-dissection
Support Technologies
We support diverse technologies for IVD development and scale-up activities that may require automated DNA extraction and liquid-handling systems.
EXO-NET® Pan-Exosome Capture
EXO-NET® Pan-Exosome Capture is an immunoaffinity magnetic bead-based isolation system for exosome isolation from plasma, serum, urine, saliva and cell-conditioned medium. EXO-NET is the highest-efficiency exosome isolation solution available
EXO-NET is Compatible for use with the following downstream applications:
- NGS
- qPCR
- Mass Spec
- ELISA
- FTIR
- FACs
Automation
- Hamilton Star
- QIACube®
- QIASymphony® SP
- Scale-up applications
ELISA (Immunoassay)
- Direct and Sandwich ELISA
- Identify and qualify commercial fit for purpose ELISA kits for PK & PD studies
- Wide applicability for assay development
- Analyte detection e.g., cytokines