Cerus Says FDA Accepts IDE Submission For INTERCEPT - Quick Facts

(RTTNews) - Cerus Corp. (CERS) Tuesday said the U.S. Food and Drug Administration has accepted its clinical protocol to make the INTERCEPT Blood System for platelets available under an Expanded Access Investigational Device Exemption or IDE to regions in the U.S. with outbreaks of Chikungunya and dengue virus.

Cerus' clinical protocol was submitted to the FDA in September under the Treatment Use provision, which allows for early access to a medical treatment not yet approved in the U.S. when no satisfactory alternative is available to treat patients with serious or life-threatening conditions.

Under the IDE, INTERCEPT treatment can be performed in place of bacterial detection, gamma irradiation, and CMV testing, leading to simplified logistics and timely release of platelet products.

Currently, there are no licensed tests to detect Chikungunya or dengue virus in asymptomatic blood donors.

The INTERCEPT blood system provides the potential to reduce the risk of transfusion-transmitted dengue and Chikungunya virus, as shown in the French Antilles blood center which has used INTERCEPT technology for 6 years.

The reviews of Cerus' Premarket Approval submissions for INTERCEPT plasma and platelets will continue in parallel with the Treatment Use IDE study. Approval decisions for both PMA submissions are expected in 2015.

The stock, which closed at $4.00 on Monday, gained over 5 percent in pre-market activity.