The FDA has issued a 510(k) clearance of a rapid, disposable test (InflammaDry, Rapid Pathogen Screening Inc. [RPS]) to aid in the diagnosis of dry eye disease for sale in the United States.
Sarasota, FL-The FDA has issued a 510(k) clearance of a rapid, disposable test (InflammaDry, Rapid Pathogen Screening Inc. [RPS]) to aid in the diagnosis of dry eye disease for sale in the United States.
InflammaDry is the first and only in-office test to detect matrix metalloproteinase 9, a clinically relevant inflammatory marker that is consistently elevated in the tears of patients with dry eye disease, the company reports. The affordable, single-use test requires no additional equipment to administer or interpret results.
Using only a small sample of human tears, the simple process takes less than 2 minutes to complete and can be performed by a technician during a patient’s initial workup. Results are available for the clinician in 10 minutes, allowing a treatment plan to be established with the patient during his or her initial office visit.
“FDA’s clearance of the . . . test is another important milestone for RPS,” said Robert Sambursky, MD, chief executive officer, president, and chairman of RPS. “[The test] will help clinicians confirm the diagnosis of dry eye before the patient leaves their office, resulting in more timely and appropriate management of [the] disease.”
Providers should not face reimbursement or coding obstacles when using this test.
“Providers should bill CPT code 83516, immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semi-quantitative, multiple step method, for the . . . test,” said Eric Donnenfeld, MD, president of the American Society of Cataract and Refractive Surgery.
Medicare payment for this code is currently $15.86.
The 510(k) clearance allows the 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 test also will 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.
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