Will This Test Let People Eat Anything They Want?

The FDA recently notified Nanosphere

that it granted 510(k) approval for the company's Verigene Staphylococcus Blood Test. The test is designed to detect the existence of bacteria within a patient's blood stream, which is the common cause of Staph infections. The approval is the first step towards marketing the test, as the company hopes to use a test cartridge comprised of up to 16 different bacteria and resistance markers. The FDA is currently reviewing the test panel application. The Verigene test detects Staph infection bacteria within 2.5 hours, a significant improvement over current tests which can take up to 3 days to obtain results. "With the BC-S test, clinicians diagnosing patients suspected of deadly infections have a rapid, accurate diagnostic tool which can differentiate two Staphylococcus bacteria, while simultaneously determining antibiotic resistance within the timeframe of making treatment decisions," said Nanosphere CEO Bill Moffitt. Staph infections are especially prevalent in cases of food poisoning. Contaminated food often carries high levels of Staphylococcus bacteria, which can multiply and produce toxins when food is stored at room temperature. Foods such as meat and poultry typically spoil at temperatures between 40°F and 140°F. Verigene's ability for rapid detection is a huge advantage in that poisoning symptoms often come on quickly after initial consumption of spoiled food. Many patients become sick for 2 days, but could need an additional 3 days for complete recovery. Symptoms include vomiting, stomach cramps, and diarrhea. The Verigene System allows for several tests to be run using the same sample. The system uses procedures that measure the death rates of a drug or biochemical in an organism. Such technology would allow for a greater degree of efficiency in testing and generate interest in the company's products. Recent sales growth is a sign that the company's investments would put it on a path to profitability. "I don't think there's a question that the technology works," stated Research 2.0 analyst Steve Waite after a previous earnings report, who believes the company may have to raise capital. "I think that 2011 is shaping up to be an inflection point for the company. Once they get their capital raised, it is a matter of going into the market, going into the hospitals, getting the regulatory approval and rocking and rolling." Nanosphere is a small company that appeals to a limited group of investors. However, biotech traders could take advantage of the current volatility to make some money. Long term investors who believe in the Verigene technology could see a benefit if the company receives final approval from the FDA. However, the company still does not have enough capital and investors should be aware that another stock offering is very possible.