The Dry Eye Zone

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Diagnostics: Health Canada approves InflammaDry Detector

RPS Announces Health Canada Approval of RPS InflammaDry Detector™
(August 22, 2011)
Ten-minute test allows clinicians to detect inflammation in the tears of patients with Dry Eye disease


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Sarasota, FL (PRWEB) August 22, 2011

On August 11, Health Canada granted Rapid Pathogen Screening, Inc. a Medical Device License for the RPS InflammaDry Detector, the first and only rapid, in-office test to detect elevated levels of MMP-9 in tear fluid. Receiving a Medical Device License allows RPS to begin marketing the RPS InflammaDry Detector in Canada, following the product’s recent release in Europe and Asia. RPS anticipates that the RPS InflammaDry Detector will soon be available for sale in Canada through a reputable distribution partner.

Clinical signs of Dry Eye aren’t always directly related to patient complaints, making this disease difficult to diagnose. Additionally, inflammation is often present in Dry Eye patients long before the appearance of clinical signs. Matrix metalloproteinase-9 (MMP-9) is an inflammatory marker that has consistently been shown to be elevated in the tears of patients with Dry Eye disease. Elevated levels of MMP-9 correlate with clinical exam findings and research shows that MMP-9 may be a more sensitive marker than clinical signs when diagnosing Dry Eye. In addition, studies show that the diagnosis and treatment of elevated levels of MMP-9 prior to LASIK surgery may result in improved wound healing and reduced complications.

The RPS InflammaDry Detector requires only a small sample of human tears to detect elevated levels of MMP-9 and provides results in just 10 minutes. Similar to the company’s first product, the presence of a single blue control line indicates a negative test result and the appearance of both a blue control line and a red result line indicate a positive result. This in-office test can be performed on patients that present with signs and symptoms of Dry Eye or as part of pre-operative screening on patients having LASIK or cataract surgery. By using the RPS InflammaDry Detector, clinicians can make an accurate diagnosis and implement an appropriate treatment plan before patients leave the office.

“Receiving a Medical Device License from Health Canada for the RPS InflammaDry Detector is yet another exciting recent accomplishment for RPS,” says Dr. Robert Sambursky, president and chief medical officer of RPS. “Providing clinicians with a rapid and accurate in-office screening test to detect hidden Dry Eye disease will help identify patients that may benefit from perioperative therapy to improve their ocular surface, leading to better surgical and medical patient outcomes.”

The RPS InflammaDry Detector has a clinical sensitivity of 85% and a specificity of 94%. This level of accuracy allows the clinician to make an appropriate diagnosis and an informed treatment decision during the initial office visit. To learn more about the RPS InflammaDry Detector or other RPS products, visit http://www.rpsdetectors.com.
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