Rapid Pathogen Screening Inc. announced it has received a Clinical Laboratory Improvement Amendments waiver from the U.S. Food and Drug Administration for InflammaDry.
InflammaDry is a rapid, disposable, in-office test to aid in the diagnosis of dry eye disease, according to a company press release.
The CLIA waiver, in conjunction with its 510(k) clearance, enables InflammaDry to be used throughout the U.S., the company said.
The press released explained that the InflammaDry test detects elevated levels of matrix metalloproteinase 9, a clinically relevant inflammatory marker, in the tears of patients with dry eye disease.
The test requires no additional equipment, according to RPS. It uses a small sample of human tears, and the four steps take less than 2 minutes to complete. Results are available in less than 10 minutes.
The InflammaDry test is CE-marked and commercially available in Europe, Canada and many other countries. RPS added that InflammaDry inventory will be available for sale in the U.S. sometime this month.