The authors of “Placental Alpha Microglobulin-1 Compared With Fetal Fibronectin to Predict Preterm Delivery in Symptomatic Women”1 would like to clarify the role of the sponsor in the study. As indicated in the published article, Parsagen Diagnostics, Inc. (Boston, MA) provided sponsorship for this study, including the PartoSure test kits. The study design resulted from input from the clinical investigators, U.S. Food and Drug Administration (FDA) advisors, and other consultants retained by the company. As the data in this study were used to support a regulatory submission, the company contracted a clinical research organization (CRO) to assist in the design of the study and its monitoring to ensure that the data produced by the study were eligible to support FDA approval of the product. Data collection was performed by the local research teams at each institution. Parsagen Diagnostics conducted monitoring visits and site audits to ensure that the data collection was robust and sufficient to support the regulatory submission. The authors of the article (Wing et al) had access to the data.
In addition, the authors would like to update the Financial Disclosure as follows: “Dr. Wing was the principal investigator on the study discussed, and has been a consultant for Parsagen, for which she receives no compensation. She has provided expert opinion to the company on a few clinical questions raised by the FDA in the company's ongoing discussions with the FDA. The other authors did not report any potential conflicts of interest.”
A Letter and Reply related to this article appears in this issue. See page 743.
1. Wing DA, Haeri S, Silber AC, Roth CK, Weiner CP, Echebiri NC, et al. Placental alpha microglobulin-1 compared with fetal fibronectin to predict preterm delivery in symptomatic women. Obstet Gynecol 2017;130:1183–91.