Using state-of-the-art bioinformatics and proprietary automation-assisted protein engineering techniques, SenGenix Inc. is developing specific molecular sensors for each analyte in its POCT product portfolio, keeping test strips and the detector as simple and inexpensive as possible. At the core of this technology are engineered proteins into which a fluorescent molecule has been integrated. Fluorescently responsive sensors (FRSs) can be printed onto a test strip and report on the presence and level of a clinical analyte. Unlike conventional, lab-on-a-chip (LOC) enzyme-based assays, FRS-based strips require neither addition of substrates, nor long measurement times. Following introduction of a small drop of blood onto a test strip, containing an FRS, a reader illuminates the FRSs, causing fast optical responses that are measured by a small, inexpensive electronic camera system. This technology has a number of characteristics that make it superior to current LOC technologies:

  • Cost of goods:  Unlike LOCs, no complex chemical reactions or separations requiring an expensive sampling cartridge with extensive on-board microfluidic circuitry will be needed.  Instead, reagent-free FRSs can be printed onto a strip, which is straightforward to manufacture.

  • Operational simplicity: Low blood volume and the absence of complex test procedures will allow for CLIA waiver of all tests.  Therefore, tests can be performed in nearly any environment from the Emergency Department or Operating Room, to primary care offices.

  • Fast: Results can be read in seconds, allowing physicians to make rapid clinical decisions at the point of care.

  • High accuracy: FRSs are engineered specifically to respond accurately at clinically relevant analyte concentrations.  Multiple engineered FRSs can cover extensive concentration ranges.

  • Extendable:  The intrinsic modularity of the technology enables new sensors to be built and incorporated into the same platform for a wide variety of clinical analytes, including electrolytes, metabolites, drugs, proteins, and cells. The same optical reading device can be used for many different sensors and applications, requiring only re-programming of an interface to develop new applications, rather than re-engineering an LOC.  Accordingly, the same manufacturing line can be used to   produce a wide array of products.