Fit-for-purpose · Precision medicine · Companion diagnostics
Biomarker discovery, characterization, and validation from a diagnostic-focused CRO — with assays developed, validated, and performed to GxP, CLIA, and FDA standards.
Fit-for-purpose solutions
Biomarker discovery in precision medicine is complex and nuanced. Technology and platform selection affects testing throughput, the path to regulatory clearance for a companion diagnostic, the ability to scale, and commercialization, including reimbursement.
Our team develops, validates, and performs assays to regulated standards (GxP, CLIA, FDA), and supports the regulatory filings that follow.
Oncology
Inflammatory & autoimmune
Neurodegenerative
Metabolic disease
Paths for your biomarker
Choose the path that fits your program today. Each is built to carry forward to the next.
Identify and characterize candidate DNA, RNA, protein, or metabolite biomarkers with fit-for-purpose research assays.
Assays customized to your application and performed exclusively in our regulated CLIA laboratory.
Custom-manufactured kits built on-site and shipped globally so third parties can run your assay.
Development and validation of your laboratory-developed test (LDT).
Development of an IVD diagnostic through regulatory approval for full commercialization.
Tell us about your biomarker and how you plan to use it. We will recommend the fastest fit-for-purpose route.
Biomarker basics
A biomarker is a measurable DNA, RNA, protein, or metabolite characteristic, analyzed qualitatively or quantitatively in a specific sample type.
How a biomarker will be used — its category — determines the evidence and validation it needs. FDA and NIH define seven categories.
Source: FDA-NIH Biomarker Working Group, BEST (Biomarkers, EndpointS, and other Tools) Resource; summarized in Califf, Exp Biol Med 2018.
Susceptibility / risk
Indicates the potential to develop a disease in someone who does not have it
Diagnostic
Detects or confirms a disease, or identifies a disease subtype
Monitoring
Measured serially to track disease status or a treatment’s effect
Prognostic
Indicates the likelihood of progression or recurrence in someone with the disease
Predictive
Identifies who is more likely to benefit from, or be harmed by, a treatment
Pharmacodynamic / response
Changes in response to a medical product
Safety
Signals the likelihood, presence, or extent of toxicity
Precision medicine
Not all patients with the same disease share the same genetic and biomarker profile. Identifying who will and will not benefit from a therapy is now central to drug development and to personalizing treatment, dosing, and monitoring.
When a targeted therapy’s safe and effective use depends on a test, FDA expects a companion diagnostic (CDx) to select the right patients — developed alongside the drug.
Next-generation sequencing (NGS) has become a preferred method for novel biomarker discovery and drug target identification, revealing the genomic alterations and pathways behind disease.
See how we support each step, from the clinical trial assay and bridging study to the marketing submission and kit manufacturing.
Technologies
Platform agnostic, your platform or ours. Testing is performed at PacificDx, our CLIA-certified, CAP-accredited laboratory.
Targeted panels, RNA-seq, and custom NGS for discovery and validation.
Gene expression, copy number, genotyping, methylation, and rare-mutation detection.
Tell us about your biomarker, your sample type, and how you plan to use the result.