Sarasota, Fl (PRWEB) November 25, 2013
Rapid Pathogen Screening, Inc. (RPS®) today announced that the U.S. Food and Drug Administration (FDA) has cleared InflammaDry® – a rapid, disposable, in-office test to aid in the diagnosis of dry eye disease – for sale in the United States.
Dry eye is a multifactorial disease that often leads to inflammation and results in discomfort, visual disturbance, and tear film instability, with potential damage to the ocular surface. It is estimated that more than 30 million people suffer from dry eye in the United States. Factors contributing to dry eye disease include age, environment, medical conditions, and hormonal changes, among others. Accurate diagnosis of dry eye is especially critical before ocular surgery is performed. Clinical studies by Fournié and Mutoh have demonstrated that diagnosis and treatment of dry eye disease prior to refractive surgery has resulted in improved healing and reduced complications.
InflammaDry is the first and only, rapid, in-office test to detect matrix metalloproteinase 9 (MMP-9), a clinically relevant inflammatory marker that is consistently elevated in the tears of patients with dry eye disease. The test plays an essential role in accurately diagnosing dry eye disease, as clinical signs of the condition resemble other eye ailments and are not always directly related to patient complaints.
“FDA’s clearance of the InflammaDry test is another important milestone for RPS,” said Robert Sambursky, MD, chief executive officer, president, and chairman of RPS. “InflammaDry will help clinicians confirm the diagnosis of dry eye before the patient leaves their office, resulting in more timely and appropriate management of their disease.”
InflammaDry is an affordable, single-use test that requires no additional equipment to administer or interpret results. Using only a small sample of human tears, the simple, four-step InflammaDry process takes less than two minutes to complete and can be performed by a technician during a patient’s initial workup. Results are available for the clinician in just ten minutes, allowing a treatment plan to be established with the patient during their initial office visit. Similar to the company’s other diagnostic test, AdenoPlus®, the test displays a blue control line for a negative result, or blue and red lines for a positive result.
Providers should not face reimbursement or coding obstacles when using this test. According to Eric Donnenfeld, MD, FAAO, president of the American Society of Cataract and Refractive Surgery (ASCRS), “providers should bill CPT code 83516, immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method, for the InflammaDry test.” Medicare payment for this code is currently $15.86. “The ability to report a CPT code and receive a reasonable payment for this test will help to facilitate patient access,” said Donnenfeld.
“Of course, providers should always follow specific payer guidelines and contact the specific payer if they have any questions regarding billing or payment,” said Sambursky. “Reimbursement is dynamic and new codes and changes are implemented annually.”
The 510(k) clearance allows the InflammaDry test to be used in physician offices that are certified to perform moderately complex tests under the Centers for Medicare and Medicaid Services’ Clinical Laboratory Improvement Amendments (CLIA). The InflammaDry test will also be submitted to FDA for CLIA waiver review. If granted, a waived status would allow the test to be used in any CLIA-waived physician office. For more information, visit http://www.InflammaDry.com. To pre-order the InflammaDry test, email info(at)InflammaDry(dot)com or call 941.556.1850.
Founded in 2004, Rapid Pathogen Screening, Inc. (RPS®) is an emerging developer, manufacturer, and marketer of rapid point-of-care (POC) diagnostic tests. The company’s innovative and patented technology platform facilitates the development of a spectrum of cost-effective tests to support the rapid diagnosis of patients with infectious diseases and inflammatory conditions. As a result of U.S. government contracts, this platform is also being developed to help detect the body’s immune response to viral and bacterial infections as well as chemical nerve agent blood toxins. RPS tests have high sensitivity and specificity, and can be easily performed by a clinician or their staff without extensive training or additional equipment. For more information on RPS or its products, visit RPSdetectors.com.
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For additional information, contact:
Laura Lovejoy, 941.928.9025, laura(at)saranova(dot)net