On January 14, 2013, the U.S. Food and Drug Administration (FDA) announced that for the first time it will permit marketing for a new diagnostic test that has the ability to simultaneously detect up to eleven (11) prevalent bacterial, viral, and parasitic causes for infectious gastroenteritis from a single sample from a patient. The FDA’s announcement may be accessed here.
An inflammation of the stomach and intestines, infectious gastroenteritis is caused by certain parasites, bacteria, or viruses and can be detected by common symptoms such as diarrhea, vomiting. The condition can be a serious affliction for infants, the elderly, and anyone suffering from a weakened immune system. Further, it can be spread quickly by contaminated water, food, and surfaces as well as person-to-person contact. As recently reported by the Centers for Disease Control and Prevention (CDC), there was a significant spike in gastroenteritis-associated deaths in the United States in the period from 1999 to 2007, with an increase from just under 7,000 to more than 17,000 deaths annually. Accounting for almost two-thirds of those deaths were Norovirus and Clostridium difficile.
The manufacturer of xTAG Gastroenteritis Pathogen Panel (GPP), Luminex, Inc., gained clearance for its multiplexed nucleic acid test through a clinical trial, wherein the Company demonstrated the device’s effectiveness in detecting the following causes of gastroenteritis:
- Clostridium difficile
- Shiga-like Toxin producing E. coli
- Enterotoxigenic Escherichia coli
- Esrcherichia coli
- Rotavirus A
Because of the ability to test for gastroenteritis from a multitude of sources, tests of this kind will help doctors to quickly identify the source of the problem and provide for more effective and faster treatment.
xTAG GPP was cleared by the FDA through the de novo classification process, the regulatory pathway for medical devices that are seen as being of low to moderate risk but are not comparable to a device that is already on the market. As opposed to devices that receive clearance through the widely-used 510(k) process, the de novo process is appropriate for devices that are not substantially equivalent to devices already on the market. More information about the de novo process may be accessed here.
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