Please contact us for any questions you may have about our capabilities or if you are not finding your methodology of interest. We continue to stay current with the latest advances in new technology and instrumentation. An example list of platforms and technologies we support is found here. Offering a diverse array of platforms and technologies, we can support all development and testing needs, molecular and non-molecular. We can also help with reimbursement strategy such as CPT codes, MolDx, private payers, and CMS.
#Molecular diagnostics companies bay area full
From CLIA validated LDTs, to 510(k), De Novo, ssPMA, full PMA (distributed kit), and complementary diagnostics.
We can support all types of IVD applications and regulatory submissions as well as reimbursement strategies. 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. Custom IVD Diagnostics Experienceįrom 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. 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. 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.
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