ResearchDx is a Contract Diagnostics Organization (CDO) offering complete in vitro companion diagnostic device services, known as IVD diagnostics services, within a single outsourcing operation to pharmaceutical, biotechnology, or diagnostic companies. As a unique services entity, we offer an integrated development process for multiple phase projects or discrete and tailored diagnostic projects to augment your team’s needs.
Custom IVD Diagnostics Experience
From assay concept and biomarker discovery, through clinical validation and regulatory approval, to final kit manufacture, 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.
We can support all types of IVD applications and regulatory submissions as well as reimbursement strategies. From CLIA validated LDTs, to 510(k), De Novo, ssPMA, full PMA (distributed kit), and complementary diagnostics. We can also help with reimbursement strategy such as CPT codes, MolDx, private payers, and CMS.
Broad Development Capabilities
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.
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.
Explore our broad range of services and capabilities, then tell us how we can help.