Assay Development Services for Micro Sampling Applications

Translating biomarkers into validated tests that generate informative results is a complex process. Additional complexity is generated if tests need to be conducted using a micro-sampling collection method, such as finger stick dried blood spots. We help develop, validate and implement protein biomarker tests that enable high-quality protein biomarker data from micro-sampling collection methods. We also have the ability to work with established tests, including therapeutic drug monitoring applications, in these patient-centric sample types.

Decentralized Biomarker Assays

The use of patient-centric sample types has the potential to increase the accessibility of biomarker collection to more patients, and enable the capture of informative, longitudinal data that would not otherwise be feasible in a traditional, fully centralized clinical trial, for example.

Nevertheless, it remains a challenge to obtain high yield, quality controlled and mechanistically informative outputs without conducting blood draws at a clinical site. ProterixBio seeks to address this challenge by validating and developing biomarker tests using patient-centric sample types. We are then able to implement the solution from our high-complexity CLIA laboratory (licensed in all 50 States), overseeing the end-to-end process from kit shipping through to data delivery.

Improve patient engagement and capture
analytical quality biomarker information at-home

Our Services

We begin by determining the technology platform and sample type that best fits the needs of the project. We have expertise with remote sample collection devices such as dried blood spots and plasma/serum separation devices. The majority of our development work to date has been with Dx grade Whatman 903 cards and ADX Separator Cards. However, we have conducted preliminary experiments and associated assays with a wide range of other patient-centric blood collection devices. Please contact us to learn more.

Once an appropriate assay methodology and sample type has been determined, we will conduct the sample collections and assay validations required to develop and validate the assay to CLIA standards.

Our high-complexity CLIA laboratory is licensed in all 50 States, and we are able to take oversight of all elements of the sample handling process.

If you need to establish an immunoassay to fit-for-purpose or clinical grade performance, possibly including a micro-sampling collection method, please contact us.