Laboratory results
without the lab

MBio's technology focus is based on these guiding principles:

• Improve accessibility of critical disease diagnosis by providing multiple, laboratory quality results from a single sample at the point of care
• Develop systems with a design ethic of user-experience, maximizing intuitive,ease-of-use
• Deliver instruments that capitalize on healthcare system advances in information connectivity, speed, and data management

A first demonstration of this focus is MBio's MQ multiplexed assay system, which delivers quantitative fluorescence immunoassay results for panels of analytes - all from a single drop of blood, plasma, or serum. MQ is a simple reader and disposable cartridge system for point-of-care testing. MQ provides the data quality and multiple results of a clinical laboratory analyzer in an inexpensive format with workflow comparable to single analyte rapid diagnostic tests. Under design for a CLIA-waiver, the simple system uses minimal sample (5 to 10 microliters) and delivers results in less than 30 minutes. The MBio technologies fill an unmet need for near patient disease panels.

MBIO LIGHTDECK™

MBio's diagnostic systems are all built on the company's LightDeck technology. LightDeck is a patent-protected fluorescence assay illumination method that is simultaneously simple, inexpensive and remarkably robust. LightDeck is a variation on planar waveguide technology, an approach that has been used for performing sensitive biological assays for over two decades. The basic principle in the context of multiplexed immunoassay is illustrated here:

In a planar waveguide device, light (typically from a laser) is directed into a flat substrate as shown above. If the angle of propagation is right, light is confined to the substrate by what is called total internal reflection. At the surface where total internal reflection takes place an evanescent field is created within about 100 nanometers of the surface. It is this localized evanescent field that serves as the illumination light for fluorescence based assays at the solid-liquid interface. There are two major advantages of evanescent illumination:

• Localization of light at the assay surface renders the system relatively insensitive to contaminants in the bulk solution. This is a tremendous advantage for the design of fluidic cartridge devices, as wash steps and line-of-sight optical requirements are eliminated.
• Evanescent wave illumination is an extremely efficient use of light energy. Low power light sources can be used to illuminate large assay surface areas. Unlike fluorescence microscopes that use high power lamps, lasers, or LEDs, planar waveguide device can use relatively low power diode lasers for illumination. This enables low power, low cost instrumentation.

The advantages listed above are features of all planar waveguide based devices. MBio's LightDeck offers further major improvements over existing techniques. First, the proprietary design incorporates an integrated lens as part of the waveguide component, solving light coupling reproducibility problems that have fundamentally limited widespread use of waveguide devices. The custom lens designs are the subject of multiple issued patents and patent applications. Second, the LightDeck platform is compatible with conventional injection molding, a key feature for high volume, low cost applications.

The image below was generated using MBio's LightDeck technology. It shows a processed 30 feature microarray that delivers simultaneous seroreactivity results for HIV-1, syphilis, hepatitis C, as well as sample, detect reagent, and non-specific binding controls, all from a 10 microliter clinical whole blood sample. The system used to generate the image consists of low cost laser diode, an inexpensive filter/lens stack and a CMOS imaging chip. There are no complicated scanning or advanced optics requirements. A proprietary beam homogenization technique is used to eliminate laser coherence effects, yielding very flat field illumination and images.

LightDeck enables a new class of inexpensive, sensitive biological assay systems. MBio's demonstrated applications include multiplexed fluorescence immunoassays, protein arrays, and nucleic acid hybridization assays. LightDeck can also be configured for multi-wavelength fluorescence microscopy, enabling portable cell-based assays without expensive microscopy or flow cytometry equipment.

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