Boston, MA 10/07/2014 (wallstreetpr) – Cerus Corporation (NASDAQ:CERS)’s clinical protocol for the INTERCEPT Blood System for platelets got accepted by the U.S. FDA. The protocol submission was to make the INTERCEPT for available under an Expanded Access IDE (Investigational Device Exemption) to regions with outbreaks of dengue and Chikungunya virus.
This approval will allow use of INTERCEPT in place of bacterial detection, CMV testing and gamma irradiation, and enabling timely release of platelet products with simplified logistics. The company noted that currently there are no licensed tests to diagnose dengue or Chikungunya virus in asymptomatic blood donors. The company has also submitted PMA (Premarket Approval) for INTERCEPT plasma and platelets which are currently under review. The company expects approval decisions for PMA in 2015.
Protocol Submission to the FDA
Cerus Corporation (NASDAQ:CERS) submitted the clinical protocol to the U.S. FDA in September 2014, under the Treatment Use provision. In the absence of satisfactory alternative to treat patients with serious conditions, this provision allows early use of therapy in the U.S., even before their approval.
The company’s SVP of regulatory affairs, Carol Moore expressed that the approval will allow early use of INTERCEPT Blood System for platelets in the U.S. hospitals and blood centers. He also noted that the IDE approval will also allow commencing the first study before the end of this year.
About INTERCEPT
French Antilles blood center uses Cerus Corporation (NASDAQ:CERS)’s INTERCEPT blood system for six years. The system essentially reduces the risk of transfusion-transmitted Chikungunya and dengue virus. Dengue virus is highly prevalent in the Caribbean region, and the local transmission is also reported in Florida and Texas. The CDC has notified 11 cases of locally-transmitted Chikungunya in Florida, 45 cases in the U.S. Virgin Islands and over 400 cases in Puerto Rico, as at September 30, 2014. INTERCEPT platelet system has been approved in Europe for more than a decade and is under review in the U.S. Canada, China and Brazil.
