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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.

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In situ proximity ligation is a highly sensitive and specific method for the detection of proteins, protein-protein interactions, and protein modifications in tissue sections (immunohistochemistry) or cells (immunocytochemistry and flow cytometry). The assay utilizes either a polyclonal antibody or a pair of matched monoclonal antibodies conjugated to two separate oligonucleotides. Binding of the antibodies to adjacent epitopes on an analyte brings the oligonucleotide sequences into proximity, where they are able to hybridize via connector oligos, forming a circular DNA template that is then amplified by Rolling Circle Amplification (RCA). In situ proximity ligation leverages the specificity of dual antibody binding and the sensitivity of DNA amplification by RCA, effectively converting a single pair of antibody binding events into a large quantity of concatemeric DNA. Since the circular template for amplification can only be formed when two separate antibodies bind to epitopes on the same target protein or protein complex, non-specific binding and background signal are minimized. Fluor-labeled oligos hybridize to complementary sequences within the amplified DNA. This allows for highly sensitive and specific detection of antibody binding, with excellent spatial localization within the tissue or cell sample using fluorescent microscopy or quantification by flow cytometry.

In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body. These tests are strong tools for monitoring health. They can detect diseases and infections, and can therefore help cure, treat, and prevent them.

IVDs also play key roles in precision medicine. For example, compared to other technologies, next generation sequencing (NGS) tests boast lower turn-around-times and greater sensitivity levels when evaluating genomic variants in a person's DNA. This makes them effective tools for identifying specific treatments or therapies a patient would most likely benefit from, based on the individual's genetic information.

TriLink offers the best in cutting-edge reagent and kit components for your in vitro assays and IVD needs.

Laboratory development tests (LDTs) are in vitro diagnostic (IVD) tests designed, manufactured, and utilized within a single laboratory. They provide high quality results for patients suffering from conditions for which no commercial test yet exists, or for which existing tests fail to meet the evolving clinical needs of. Therefore, the majority of LDTs have been developed in response to an unmet need, and are not commercially available. LDTs can detect a wide variety of substances in a human sample, such as proteins, chemical compounds, and nucleic acids. Their complexity varies from single analyte identification, to measuring and detecting multiple analytes in a single sample. For example, certain tests will simply measure sodium levels, while others are usefool tools for diagnosing genetic diseases, as they are able to detect multiple DNA variants from a single blood sample.

The FDA only considers diagnostic devices LDTs if they are fully and completely manufactured in the laboratory that offers and utilizes them. Results from LDTs and IVD tests inform patient treatment, which is why it is of the utmost importance that they are accurate and timely. Patients deserve the best care available to them, without becoming exposed to inappropriate therapies, treatments, or delays. Integrating TriLink as part of your test design is a preliminary step to ensure the success of your LDT.

Analyte Specific Reagents (ASRs) are molecules used to identify and measure how much of a given substance is present in a biological specimen. They are intended for diagnostic applications, as they can identify and quantify an individual chemical substance in a specimen through specific binding or chemical reactions with multiple substances in the specimen. Simply put, an ASR is the active ingredient of an in-house test. TriLink Molecules that fall under this category include, but are not limited to, nucleic acid sequences and more.

ASRs are considered medical devices, and as such, they are regulated by the U.S Food and Drug Administration (FDA). The FDA created this regulatory status to ensure that reagents with specific quality requirements would be made readily available for clinical laboratories developing Laboratory Developed Tests (LDTs).

Mitochondrial DNA (mtDNA) analysis has been used in cases that are challenging due to small or compromised samples, where nuclear DNA is insufficient to generate useful results. Due to the abundance of mtDNA in the cell, it's a go-to tool in the forensic analysis of missing persons and victims of mass disaster.

mtDNA sequencing is applied to samples that do not contain nuclear DNA (nDNA) or have significantly compromised nDNA, such as highly degraded specimens and hair samples. Typical sample types analyzed include hair, bone, teeth, nails, blood, and tissue. The mtDNA sequencing process includes multiple steps: DNA extraction, DNA quantification and normalization, HV1 and HV2 amplification, cycle sequencing, electrophoresis, and analysis. mtDNA sequencing is also used in medical, evolutionary, migration, and genealogical studies.

Our strong commitment to quality and service has made us a natural choice for mtDNA primer synthesis. Due to the volume of mtDNA sequencing samples processed by laboratories each year, it is critical to have a streamlined protocol to:

Reduce the chance for error
Minimize cross-contamination between samples
Save time

TriLink offers reagents that simplify the PCR amplification and cycle sequencing steps of mtDNA analysis. mitoPrimers™ are a validated set of primers for amplification of human mtDNA hypervariable regions 1 and 2 (HV1/HV2).