FDA approves in-office test for dry eye

The FDA has approved for sale the in-office, disposable test for dry eye, InflammaDry. 

The company says this is the first and only, rapid, in-office test to detect matrix metalloproteinase 9 (MMP-9), an inflammatory marker elevated in the tears of patients with dry eye disease.

“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,” said Robert Sambursky, MD, CEO, president and chairman of Rapid Pathogen Screening, Inc.

The company says InflammaDry is an affordable, single-use test that requires no additional equipment to administer or interpret results. Using a small sample of human tears, the 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 10 minutes.

According to Eric Donnenfeld, MD, FAAO, president of the American Society of Cataract and Refractive Surgery, “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.”

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 company will request a CLIA waiver review for the test. If granted, that would allow the test to be used in any CLIA-waived physician office.