Rapid Pathogen Screening Receives Medical Device License for InflammaDry Detector

The point-of-care diagnostic tests manufacturer, Rapid Pathogen Screening (RPS) was granted a medical device license for their in-office RPS InflammaDry Detector by Health Canada on August 11, 2011. The medical device license will allow RPS to market the RPS InflammaDry Detector in Canada. The product was recently released in Asia and Europe.

RPS InflammaDry detector has been designed to detect elevated matrix metalloproteinase-9 (MMP-9) levels in tear fluids, making it easier to diagnose dry eye. MMP-9 is an inflammatory marker. Research indicates that elevated MMP-9 levels correlates to the dry eye disease. Since inflammation is usually present in dry eye patients before clinical signs can be detected, the RPS InflammaDry Detector uses a human tear sample to instantly detect the MMP-9 levels. The detector provides the results in a short span of 10 minutes. Studies indicate that the treatment of elevated MMP-9 levels preceding LASIK surgery could result in enhanced wound healing and leads to lesser complications.

Since the detector can be used for in-office testing and can be performed on patients who exhibit symptoms of dry eye, clinicians can instantly provide the patient with an accurate diagnosis. The detector can also be used as a pre-operative screening for cataract or LASIK surgery.

The InflammaDry Detector has a specificity of 94 % and a clinical sensitivity of 85 %. The President of RPS, Dr Robert Sambursky stated that the device will empower clinicians to rapidly and accurately screen and detect dry eye disease and provide patients the treatment to improve the ocular surface of the eye.

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