Capabilities

Technologies and services for IVD development, from bench to commercial launch

We support sequencing, PCR, cell and tissue, immunoassay and exosome technologies for diagnostics in oncology, infectious disease and heritable disease. Need a platform not listed here? Ask us.

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Custom laboratory services

Engagement models that fit your program

Every engagement runs in our CLIA certified, CAP accredited facility, or at yours.

Commercial

Full commercial development

We develop, validate and launch your custom assay in our accredited facility, and can support MolDX submissions, billing and sale of the test.

Clinical trials

Clinical trial assay development

Custom development and validation of the assay for your clinical trial or CDx program, plus sample collection, testing and project management.

Confidential

Proprietary validation and testing

Still in stealth mode, or need an assay used only by your organization? We set up fully confidential workflows.

Regulatory

Site-specific 510(k) and PMA

Extensive experience submitting site-specific IVDs, with full-service submissions at your site or ours.

Your own lab

Contract laboratory development

A full-stack service that gives you your own CLIA certified, CAP accredited, licensed facility, staffed by ResearchDx personnel at your site or ours.

Early research

Pre-clinical and biomarker support

PBMC processing, nucleic acid extraction, biorepository storage, antibody binding and neutralization studies, and PK assay development.

Next-generation sequencing

Targeted and comprehensive NGS panels

Validated Illumina panels, plus custom panels, RNA-Seq, miRNA-Seq, exome and genome sequencing.

Illumina

TruSight Oncology 500

SNV, indel, CNV and fusion analysis across 523 cancer-related genes, plus tumor mutational burden (TMB) and microsatellite instability (MSI). A strong biomarker discovery tool.

PCR and molecular cytogenetics

Quantitative molecular methods

qPCR (quantitative real-time PCR)

Gene expression and low-abundance transcripts
Copy number variation, including absolute CNV
SNP genotyping and allelic discrimination
Methylation (CpG) analysis
Pathogen detection and QC
ctDNA and cfDNA in liquid biopsy
Vector copy number and viral titer
Confirmatory testing

Droplet digital PCR (ddPCR)

Absolute quantification
Rare sequence and mutation detection
NGS pre- and post-run validation
Sensitive CNV detection
Viral titer and nucleic acid qualification
Single-cell analysis and gene editing event detection
Gene expression and miRNA analysis
cfDNA liquid biopsy and gene therapy vector biodistribution

FISH (RNA or DNA)

All commercially available probes
Custom probe design and manufacture
RUO, IUO and GMP probe manufacture

More technologies

Cell, tissue, protein and supporting platforms

Flow cytometry

Custom CLIA and GLP flow panels for immunophenotyping and receptor occupancy.

Cell and tissue methods

Anatomic pathology and cytogenetics, particularly for oncology.

ELISA and immunoassays

Direct and sandwich ELISA, fit-for-purpose kit qualification for PK and PD studies, and analyte detection such as cytokines.

EXO-NET® exosome capture

Immunoaffinity magnetic-bead isolation from plasma, serum, urine, saliva and conditioned medium, compatible with NGS, qPCR, mass spec, ELISA, FTIR and flow.

Automation and scale-up

Hamilton STAR, QIAcube® and QIAsymphony® SP for automated extraction and liquid handling.

Not seeing your platform?

We regularly evaluate and onboard new technologies. Tell us what you need.

Let's match the right technology to your assay

Share your intended use and sample type, and our scientists will recommend a platform and validation plan.

Start a discussion Assay development