“People are always asking, ‘Where is the device, where’s the box that goes with it?” says Fred Mitchell, CEO of Beacon Biotechnology, on the reaction of people the first time they see the BrightSPOT System. Observers assume that the microscope-slide sized device must be inserted into a larger docking station where the analysis is completed, as is the standard approach with most medical diagnostics. With the BrightSPOT System, however, all the analysis – for up to 112 simultaneous tests – takes place on the chip at the center of the small rectangular apparatus. The device must eventually be plugged into a computer’s USB port in order to read the output, but the heavy lifting has already been accomplished by a machine not much larger than a matchbook.
The BrightSPOT System brings together several interesting pieces of intellectual property combined to create a system that can perform a wide variety of diagnostic tests very rapidly. Contained on the BrightSPOT chip is technology that is 40 times more sensitive than a high-end luminometer at detecting light. With this light detection capability in place, the next challenge is to generate light when a positive test result is present. To create this light, the Beacon team has called on Gaussia luciferase, a bioluminescent molecule found in a marine organism that generates 1,000-fold higher signal intensity compared to firefly luciferase.
To complete the system, there remains the challenge of adding several different elements in the correct order. First, each of the 112 detection areas on the chip is spotted with a different capture probe that attracts a specific molecule. For example, in a test for HIV, the capture probe could be an HIV antigen that attracts specific antibodies only present if a person has been exposed to the virus. Next, a drop sized sample of human blood is added followed by a molecule tagged with Gaussia luciferase that will be attracted to the captured molecules. In the HIV example, this molecule would be an antihuman antibody with Gaussia luciferase that would stick to the captured HIV antibodies. The final step is to add the substrate, coelenterazine, which causes the luciferase to glow and allows the chip to detect which spots contain positive results.
Currently, the chips are spotted using a highly specialized machine while the blood sample and other materials are added manually with a pipette. To read the results, the chip is inserted into a USB converter and then into a computer. In the commercial incarnation, chips will be pre-spotted at Beacon’s production facility and packaged inside something that looks like a USB flash drive. This package will contain an area to add the patient sample. When inserted in a specially designed reader that will look similar to a PDA, blister packs containing the tagged molecule and substrate will be punctured to complete the test.
The potential applications for the test are seemingly endless, ranging from detection of bioterrorism agents to flu panels that identify specific strains (including H1N1 swine flu). Beacon recently presented data comparing the BrightSPOT test to a commercial HIV ELISA test kit. The BrightSPOT system test data showed comparable sensitivity but was 90% faster than the commercial test while using whole blood instead of the plasma required by the ELISA test. This difference makes the test accessible in places that may not have the equipment for plasma separation, a core component of the test’s value proposition across many potential applications. Mitchell comments that the BrightSPOT system affords the opportunity to offer “complex tests at the point of care,” providing physicians with the information they need to effectively treat patients wherever they may be, from “a rural clinic to the developing world.”
The company opened a round of financing in the spring of 2008 and have raised close to $1M before the September market crash. Beacon, based in Aurora, Colorado, is still seeking an additional $2M to close the round intended primarily for hiring an additional scientist, the purchase of additional laboratory equipment and the production of a commercial-ready prototype. After these milestones, Mitchell believes the company can sign on a marketing partner that will be able to provide additional funds to “complete clinical trials and commercial build up.” Getting to the first commercial test may prove Beacon’s biggest challenge, requiring both engineering of a commercial device and establishing proof of concept in the marketplace. Beyond gaining a foothold in an initial application, Mitchell believes the opportunities for the BrightSPOT system are almost limitless: “That’s the beauty of the technology – there is such a small amount of biology [that needs to be customized for each test] and it’s the same device for all panels.”
