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U.S. Department of Health and Human Services

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Research Project: Emerging Biosensors and Lab-on-a-Chip Platforms

Emerging biosensors and lab-on-a-chip platforms have many exciting applications related to FDA products.  Point-of-care (POC) in vitro diagnostics (IVD), for example, have the potential to transition diagnosis from a centralized laboratory into the doctors’ office to provide the patient and physician with more timely diagnosis and therefore treatment.  Along a similar vein personalized medicine, i.e., taking into account a patient’s particular genetic, genomic, or proteomic constitution, together with environmental and other factors, to deliver treatments that are safe and effective for that patient, has the ability to revolutionize patient treatment, reducing exposure to potentially ineffective toxic drug treatments.  POC-IVDs and IVDs related to personalized medicine have benefited from technological innovations in a variety of areas including simplified fabrication and sensor system integration, microfluidics, lab-on-chip, nanotechnology, multiplex “omics” technologies (such as DNA and protein microarrays), biomarkers, molecular biology mechanisms and systems biology.

 


Lab-on-a-trip platforms for mixing two assay reagents. The platform is designed in layers that are then cut into plastic using a laser cutter. The layers are assembled to form the resulting lab-on-a-chip.

 


These lab-on-a-chip platforms were used to perform a fluorescent assay for detection of Botulinum neurotoxin A.

 

The research projects conducted under “Emerging biosensors and lab-on-a-chip platforms” include assessing many aspects of these technologies incorporated into such IVD devices, including signal generation and transduction mechanisms, bioconjugation and labeling techniques, microfluidic generation, nanotechnology, systems integration and automation.  Biomarker detection, through the use of multiplexed antibody and/or DNA arrays, is being studied and research results can be applied to a number of biomarkers associated with disease diagnosis and personalized medicine.  Understanding the design and production of such multiplexed IVD systems, will form the scientific basis upon which the FDA can define regulatory approaches and requirements for reviewing future diagnostic-based and biomarker monitoring submissions.

 


Portable fluorescent detection platform for the measurement of Botulinum neurotoxin A.  The platform is equipped with electroluminescent strips, shown in different colors above, which are used to excite the fluorescent-based assay.  The samples are housed in simple well chips, designed in-house and the resulting fluorescence is measured using a CCD camera.

 


A typical camera image is shown with the fluorescent signal seen to increase with increasing concentrations of the Botulinum neurotoxin A light chain (LcA).  Camera images were analyzed and converted into intensity values using ImageJ software from NIH.