In Brief: Trylon's Pap Plus Speculoscopy
This article was originally published in The Gray Sheet
Executive Summary
Trylon's Pap Plus Speculoscopy: Visual cervical screening exam using the firm's Speculite disposable chemiluminescent illuminator receives FDA 510(k) clearance for the claim that it increases the sensitivity of screening, when compared with Pap smear alone, from 40% to 90%, according to the Torrance, California-based firm. Specificity, however, decreases from 95% to 80%. The firm also will provide participating Planned Parenthood clinics with the exam at no additional cost for low income, uninsured women who receive their cervical screening at the clinics...