Obtaining the CLIA waiver, in addition to its FDA 510(k) clearance, enables the InflammaDry test to be used throughout the United States.
Sarasota, FL (PRWEB) February 28, 2014
Rapid Pathogen Screening, Inc. (RPS®) today announced that it has received a Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for InflammaDry® – a rapid, disposable, in-office test to aid in the diagnosis of dry eye disease. 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 25 million people suffer from dry eye in the United States.
Obtaining the CLIA waiver, in addition to its FDA 510(k) clearance, enables the InflammaDry test to be used throughout the United States, an expansion from its current use internationally. CLIA waived status is granted to tests that are simple to perform and have an insignificant risk of producing an erroneous result. The InflammaDry test can be administered by any medical office personnel in healthcare facilities with a CLIA Certificate of Waiver.
“The millions of patients who struggle with dry eye deserve an accurate diagnosis to facilitate more timely and appropriate management of their disease,” said Robert Sambursky, MD, chief executive officer, president, and chairman of RPS. “The receipt of InflammaDry’s CLIA waiver is another significant milestone for the RPS family of products as we work to bring accurate diagnoses of ocular, inflammatory, and infectious diseases to clinicians and patients globally.”
The InflammaDry test detects elevated levels of matrix metalloproteinase 9 (MMP-9), a clinically relevant inflammatory marker, 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.
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 in just ten minutes, allowing a treatment plan to be established with the patient during their initial office visit. The InflammaDry 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 $15.74. “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 InflammaDry test is CE-marked, 510(k) cleared, and commercially available in Europe, Canada, and many countries throughout the rest of the world. RPS anticipates that InflammaDry inventory will be available for sale in the United States in March 2014. For more information or to pre-order the InflammaDry test, visit http://www.InflammaDry.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. Currently available RPS tests include AdenoPlus to aid in the diagnosis of Adenoviral conjunctivitis (pink eye) and InflammaDry to aid in the diagnosis of dry eye disease. For more information on RPS or its products, visit RPSdetectors.com.