Within precision medicine, bioassay development is a major area of need. Laboratory and point-of-care diagnostics must be accurate, reliable, and (relatively) inexpensive if they are to gain wide-spread adoption by the biomedical community. Furthermore, these analyses will typically need approval from regulatory agencies before they move beyond pure research. NIST is identifying and addressing critical areas of need to facilitate translation of benchtop research to bedside analytics, to enable the kind of personalized data acquisition that will drive healthcare in the coming decades.
Biosample preservation remains a major challenge for the biomedical community. Many studies of new biomarkers rely on banked samples, most of which have been formalin fixed and paraffin embedded. These may be unsuitable for assay development, as their content cannot be verified. To overcome this, development of reference samples would facilitate bioassay development, characterization, and verification. We are investigating methods to preserve samples in a way that does not interfere with the existing analytical architecture (i.e. pathology) and enables new analytical tools for DNA, RNA, proteins, and metabolites with unprecedented accuracy.
Additionally, new analytical tools for DNA, RNA, and proteins are in great demand. Our team has a strong history of developing microfluidic devices for handling cells and biomolecules in areas such as rare cell isolation and mRNA amplification.