FDA Clears Rapid Test for Dry Eye Disease

Megan Brooks


December 02, 2013

The US Food and Drug Administration (FDA) has approved a rapid in-office test for diagnosis of dry eye disease called InflammaDry, the developer, Rapid Pathogen Screening Inc (RPS), of Sarasota, Florida, has announced.

InflammaDry detects the inflammatory marker matrix metalloproteinase-9, which has been shown to be consistently elevated in the tears of patients with dry eye disease.

The test uses a sample of tears and takes less than 2 minutes to complete, with results available in 10 minutes. This allows a treatment plan to be established with the patient during the initial office visit. The test displays a blue control line for a negative result or blue and red lines for a positive result. 

"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," Robert Sambursky, MD, chief executive officer, president, and chairman of RPS, said in a news release.

Reached for outside comment, Glenda Secor, OD, communications chair of the American Academy of Optometry, told Medscape Medical News, "This is a pretty good test. It delineates whether the eye doctor should use an anti-inflammatory drug like a steroid or Restasis [cyclosporine, Allergan] for the patient with dry eye, with pretty good reliability."

Dry eye is a "common complaint," she added, one that increases with age," and all tools are valuable; professional judgment is still key in differentiating etiology and determining proper treatment plans to maximize outcomes," Dr. Secor said.

"The big issue," she told Medscape Medical News, "is that it is not reimbursable by insurance and if patients will pay for the additional testing out of pocket is unknown."

When using InflammaDry, "providers should bill CPT code 83516, immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method," Eric Donnenfeld, MD, president of the American Society of Cataract and Refractive Surgery, advised in the RPS news release.

Medicare payment for this code is currently $15.86. Dr. Donnenfeld said, "The ability to report a CPT code and receive a reasonable payment for this test will help to facilitate patient access."

RPS said 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 & Medicaid Services' Clinical Laboratory Improvement Amendments (CLIA).

InflammaDry will also be submitted to the FDA for CLIA waiver review. If granted, a waived status would allow the test to be used in any CLIA-waived physician office, the company said.


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