Custom Molecular Assay Development is what we do. Molecular assays are a highly specific and sensitive method of DNA or RNA detection associated with a specific target. We have the expertise to develop these assays for FDA 510(K) approval. Our state-of-the-art facilities and experienced staff enable us to provide the highest quality services to our clients. We commit to providing the best possible service and products to our customers. We focus on exceeding your expectations.

The first step is a conversation. Our scientists develop custom solutions for you by understanding your test purpose and sourcing correct reagents. We develop novel assays by testing performance, optimization, quality control and statistical validation. Protocols and supporting data are provided as the final report. At this point, the client has the chance to further optimize and validate the assay.

Molecular Assay services include:

Essential to successful custom molecular assay development is high quality reagents and high specificity and sensitivity to provide an accurate and reproducible detection system. Then, once developed, we can process samples in our CAP/CLIA laboratory.

Cross Reactivity in Molecular Assays is Key

Molecular diagnostics/point of care

We believe in improving patient care in the healthcare industry and molecular diagnostics and point of care test development is one of the most important areas in which technology is being used to do it. The term molecular diagnostics describes the identification of diseases and conditions at the genetic level. This type of testing often determines the cause of a disease, to predict how a disease will progress, or to identify individuals who are at risk for developing a certain condition. Additionally, Point of Care testing is performed at the patient’s bedside rather than in a laboratory. These types of tests are becoming increasingly important as they allow for quicker and more accurate diagnosis of a patient’s condition.

Molecular diagnostics is a rapidly growing field, and there are many different types of tests that fall under this category. Polymerase chain reaction (PCR) is one of the most common types of molecular diagnostic tests. PCR is a technique that amplifies a specific section of DNA. Therefore, PCR detects the presence of a disease-causing agent, such as a virus or bacteria and PCR identifies genetic mutations associated with certain diseases.

A blood test is one of the most common types of point of care tests. Blood tests measure a variety of different things, such as determining whether a patient has an infection, and to monitor the progress of a disease. In fact, point of care testing is a screening tool for inherited diseases too. In many cases, point of care testing can be used to identify individuals who are at risk for developing a certain condition before they ever experience any symptoms.

next generation sequencing (ngs)

Next-generation sequencing (NGS) is another type of molecular diagnostic test. NGS is a type of DNA sequencing used to identify a wide range of genetic mutations. NGS is a key diagnostic tool in the diagnosis of cancer. It identifies specific genes associated with the disease and diagnosticians use it to screen for inherited diseases and to determine an individual’s risk for developing certain conditions.

Contact us today at [email protected] or call 866-983-0667 for more information about how we can work together.

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