Custom & molecular assays · Molecular and non-molecular platforms
Custom and molecular assay development, from concept and biomarker discovery through clinical validation and regulatory approval to final kit manufacturing.
Meeting complex requirements
Our team is highly skilled in every phase of development in regulated and non-regulated environments, in the United States and abroad, supporting diagnostic development partnerships worldwide. We can step in at any stage of your project.
We offer a diverse array of platforms and technologies and support all development and testing needs, molecular and non-molecular. See the platforms and technologies we support.
300+
new assays validated since 2015
Millions
of tests performed for clients in the US and internationally
15+ years
of custom assay development experience
Intended use
An assay’s intended use defines what it can claim, who can run it, and how its results can be used. We design and document every assay for its intended use from day one.
Used for
Basic and translational research, and exploratory studies
Claims and reporting
Labeled “For Research Use Only. Not for use in diagnostic procedures.” Results are not reported for patient care.
Used for
Discovering and ranking candidate biomarkers across sample cohorts
Claims and reporting
Exploratory data that identify which markers move forward into assay development and validation.
Used for
Nonclinical safety and efficacy studies, including PK, PD and toxicology endpoints
Claims and reporting
Studies run under 21 CFR Part 58 that can support IND and other FDA submissions.
Used for
Patient testing and clinical trial endpoints in a CLIA-certified laboratory
Claims and reporting
Results can be reported to physicians. The test is run in a single certified laboratory as a laboratory developed test.
Used for
Kits and devices distributed to other laboratories or used at the point of care
Claims and reporting
Requires FDA clearance or approval (510(k), De Novo or PMA) and manufacture under a quality system such as ISO 13485.
From concept to commercialization
Bring us in for a single stage, or for the whole path from discovery to a manufactured kit.
Research-grade assays to identify and evaluate candidate biomarkers.
Fluid, tissue, cell-based, and molecular methods, optimized for your specimen and intended use.
Validation matched to the level your use requires, from research to FDA submission.
CLIA and GxP testing for clinical trials and studies at PacificDx, our accredited laboratory.
510(k), De Novo, and PMA strategy and submissions for your diagnostic.
ISO 13485 kit manufacturing for clinical trials and commercial supply.
How we develop
Define intended use, targets, specimen types, and controls; design primers, probes, or panel content.
Tune extraction, input, chemistry, and analysis so the assay performs on real samples.
Validate to the level your use requires — research, GLP, CLIA, ISO 13485, or FDA submission.
Run the assay in our CLIA laboratory, transfer it to yours, or manufacture it as a kit.
Next-generation sequencing
PCR, qPCR & ddPCR
From research-grade to FDA submission, compare what each validation level involves.
Flow cytometry
ELISA & immunoassays
LC-MS/MS
Medical device development
Exceptional assay development specialists
Pharma and biotech sponsors need increasingly complex assays and shorter turnaround times for central laboratory services — including disease- and drug-specific biomarker assessments that determine the safety and efficacy of compounds in development.
Our development team is staffed by dedicated scientists, equipped with current technologies and standardized instrumentation, with expertise in fluid, tissue, cell-based, and molecular assays for biomarker testing.
Validation levels
The right level depends on how the results will be used. Each step up adds requirements — we help you validate to the level you need now, and plan for the one you need next.
Used for
Biomarker discovery in university and research settings
What it involves
No formal requirements, but every ResearchDx validation still assesses accuracy, precision, detection limits, and reportable range
Used for
Nonclinical studies of safety and efficacy
What it involves
Fit-for-purpose validation documenting accuracy, precision, and detection limits; more studies if the data will support an FDA submission
Used for
Patient testing in clinical laboratories and clinical trials
What it involves
Accuracy, precision, analytical sensitivity and specificity, interfering substances, and reportable range; accreditors such as CAP and A2LA may add requirements
Used for
Manufactured diagnostics, including kits for clinical trials
What it involves
Validation within a quality management system that meets ISO 13485 — the basis of FDA’s QMSR
Used for
Commercially distributed IVDs and companion diagnostics
What it involves
Design controls and full analytical validation; clinical studies for some 510(k)s and typically for PMAs
Tell us your intended use and where the results will go. We will recommend a validation path.
With over 15 years of custom assay development experience, we can take on your project at any stage.