FDA clears RPS in-office test for dry eye

Rapid Pathogen Screening Inc. announced that the U.S. Food and Drug Administration has approved InflammaDry, a point-of-care diagnostic for dry eye disease, for sale in the U.S., according to a company press release.

InflammaDry detects matrix metalloproteinase 9, an inflammatory marker that has been shown to be elevated in patients with dry eye, the company said.

“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,” Rapid Pathogen Screening (RPS) Chief Executive Officer, President and Chairman Robert Sambursky, MD, said in the press release.

According to the release, a technician can collect a sample of tears for the single-use test, and the results are available in 10 minutes. The test displays a blue control line for a negative result or blue and red lines for a positive result.

Eric Donnenfeld, MD, FAAO, said in the release that providers should bill CPT code 83516, immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method.

“The ability to report a CPT code and receive a reasonable payment for this test will help facilitate patient access,” Donnenfeld said in the release.

The 510(k) clearance allows the test to be used in practices certified to perform moderately complex tests under the Centers for Medicare and Medicaid Services’ Clinical Laboratory Improvement Amendments (CLIA), according to RPS. The test will also be submitted to the FDA for CLIA waiver review.