IVD and Molecular Dx

Molecular diagnostics (Dx) refers to a series of techniques used to analyze biomarkers in the genome and proteome. These tests interrogate specific sequences in nucleic acids, as well as how cells express genes as proteins. This information can then be used to diagnose and monitor disease, detect risk, and determine the best-suited therapies for each individual patient.

In vitro diagnostics (IVDs), which are tests executed on samples taken from the human body, continue to pave the way for precision medicine by exploiting molecular testing. Results can be used in concordance with other clinical data, such as histology and immunohistochemistry, in order to gain a complete and unique picture of an individual patient's health. Clinical applications for molecular diagnostics and IVD testing include oncology, genetic disease screening, pharmacogenomics, and more.

TriLink offers a variety of stocked and custom products that are backed by the understanding that diagnostic medical device technologies require diverse modifications at different scales of synthesis. Our expertise and extensive selection of modifications and conjugates ensure that we can meet your molecular Dx nucleic acid synthesis requirements. We can do this at all stages of your product development project, at the scale and purity to fit your commercial needs.

TriLink can integrate into your program during any stage of the diagnostic project development cycle, while ensuring that manufacturing controls are in place for materials used during clinical trials. We are well-equipped for reagent technology transfer, even if your research reagents were previously obtained from other manufacturers.

TriLink understands that your program does not have fixed needs. We have a dedicated support team available to guide you on a path of optimal cost savings and efficiency, tailored to the needs of each phase of design and development.

Fulfilling Broad Customer Needs

We operate our cGMP facility under an ISO 9001 certified Quality Management System. Whether your diagnostic test is a PMA, a 510k, or is regulated as a LDT under CLIA, TriLink GMP includes preparation of reagents with a fully traceable batch record, rigorous analytical QC, QA product release, and a signed Certificate of Analysis.

We work with state-of-the-art equipment and chemistries for standard and modified backbone DNA and RNA synthesis. We use precise analytical characterization methods for oligos and oligo conjugates. Typical QC includes purity analyses (HPLC), quantity (UV spectroscopy), and identity (Mass Spectroscopy). Other analytical options available include (structure/synthesis dependent or customer specified analysis) orthogonal HPLC, CE, PAGE, and multiwavelength UV-Vis analysis.

Dedicated Partnerships
Our experienced team will work with you to integrate a range of nucleic acid categories with your product design control or commercialization plan, as applicable. We recognize the urgency of diagnostic reagent production in supporting IVD and CLIA LDT development and product realization.

Find a solution

In Situ Proximity Ligation
In Vitro Diagnostic (IVD)
Laboratory Developed Tests (LDT) & Analyte Specific Reagents (ASR)
Mitochondrial DNA (mtDNA) Analysis