Originally Published MD&DI May 2009
FROM THE EDITORS
A Bright Spot for the Future of Diagnostics
With the swine flu epidemic looming, one promising diagnostic device that could help is unfortunately still in clinical trials.
CDC says that the human swine flu outbreak continues to grow in the United States and internationally. It reports additional cases of confirmed and hospitalized swine influenza patients. Internationally, the situation is more serious too, as more countries report confirmed cases of swine flu. The situation brings to light the need for preparedness. Although maybe not in time for this possible epidemic, a device is currently in clinical trials that could help in the future. The aptly named BrightSpot can detect the presence of disease in just a single drop of body fluid. The really cool part is that it can detect a disease such as the swine flu in just 15 minutes. Unfortunately, clinical trials aren’t slated to be completed until 2012.
With the possibility of widespread contagion, perhaps this outbreak could encourage regulators to put it into action sooner. “[The outbreak of the swine flu] may indeed reduce our time to market. The need to identify and differentiate this current strain of swine flu from the ‘typical’ flu or others, like avian flu, may drive [earlier] collaboration discussions,” says Beacon Biotechnology CEO, Fred Mitchell.
The Colorado-based company has created the disposable medical device to offer clinicians much faster results than currently available technologies. The diagnostic is a tiny computer chip with 112 individually addressable detectors, each of which can perform a different test. According to the company, when a drop of blood, urine, or saliva is placed on the chip, the fluid makes its way into the detectors, which are each programmed to search for various proteins or amino acids from viruses or bacteria associated with different diseases.
“That’s the beauty of the technology,” says Mitchell. “It can perform all of these differentiations on a single sample in about 10 minutes at the point of care. There is no instrument, per se, and the cartridge is a single-use disposable.” Mitchell says the BrightSpot reader has almost unlimited diagnostic uses. It could be used by soldiers on the battlefield to look for biological warfare agents, he says.
“We have developed it to address major pandemics, like the swine flu that’s threatening to emerge,” he says. “It could be used at airports, border crossings, and at makeshift clinics designed to quarantine people infected with the disease.”
Because the system reduces the time to result, Mitchell says it can improve the quality of healthcare. “While it can perform many methods, we’re steering the technology toward more-complex immunoassay and molecular assay tests. It can essentially perform any test that one would normally perform in a microtiter plate. We’re enabling real-time healthcare—anywhere.”
The BrightSpot is proof that the sluggish economy simply can’t keep a good product or company down. “We have been experiencing the same funding issues that I believe everyone has had since last fall. In the recent months, though, it has picked up again as people gain confidence in the market,” he says. He is seeing funding sources that traditionally focused on large investment opportunities now looking more upstream at smaller ones, spreading their resources over a wider field to increase their success opportunities. Mitchell says the company was lucky in that it began to take outside funding in the spring of last year and collected sufficient funding to maintain activities through the market nosedive. He says the company continues to receive investment and to have discussions with large life science and IVD companies about collaborating.
“We’re providing doctors with a tool to help make their job easier, faster, and more cost-effective for the healthcare system.” And, at the end of the day, that’s what innovation in our industry is all about.
Sherrie Conroy for the Editors
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