Broad Custom Assay Development Capabilities
ResearchDx offers state-of-the-art custom and molecular assay development, from concept and biomarker discovery, through clinical validation and regulatory approval to final kit manufacturing. We can step in at any stage in the process to support your project needs. The ResearchDx team is highly skilled in all project phases associated with regulated and non-regulated environments in both the United States and abroad, supporting diagnostic development partnerships worldwide. Offering a diverse array of platforms and technologies, we can support all development and testing needs, molecular and non-molecular. An example list of platforms and technologies we support is found here. We continue to stay current with the latest advances in new technology and instrumentation. Please contact us for any questions you may have about our capabilities or if you are not finding your methodology of interest.
Let us build your next custom NGS panel
Or Provide NGS Solutions for Virtually Any Project
Let us design your next PCR, qPCR, or ddPCR assay
We Also Build Pre Clinical In vitro Assays
And Generate control material
- 100+ characterized control cell lines for oncology applications
- FFPE control cell block preparation
- Control DNA/RNA preparation
And develop Laboratory-Developed Tests
Laboratory-Developed Tests (LDTs) have garnered significant attention in recent years over questions relating to FDA oversight, clinical and analytical validity, and compliance with certain medical device regulations. Though having similar usage as an FDA-approved IVD test, an LDT is created and validated for use by a single clinical laboratory. LDTs continue to be important in the advancement of personalized medicine which has highlighted the importance of accuracy, clinical and analytical validity. To this end, regulatory authorities are increasingly requesting such studies under the more stringent CLIA regulations. At ResearchDx, we design and perform analytical and clinical validations for custom assays through our PacificDx clinical laboratory. Our CAP/CLIA certified lab, PacificDx offers state-of-the-art facilities and expertise to meet your immediate clinical and pre-clinical needs for high-quality clinical and biopharmaceutical testing services.
Not on our list, explore our custom development services
We have over 15 years of experience in custom assay development, we can confidently handle your custom project. Contact Us.