Boston, MA 09/10/2014 (wallstreetpr) – Cerus Corporation (NASDAQ:CERS) today reported that it has tendered a clinical protocol to the U.S. Food and Drug Administration to gain its approval on providing the company’s Intercept Blood System for platelets to blood banks in the U.S. hospitals in areas witnessing outburst of dengue and Chikungunya.
Awaited Approval
Cerus Corporation (NASDAQ:CERS) is seeking FDA approval through the agency’s Expanded Access Investigational Device Exemption procedure. The process helps in achieving early access to a medical therapy which has not yet been approved, in case of unavailability of any other satisfactory substitute to cater to patients suffering from serious life-threatening diseases. The protocol requested by Cerus seeks to provide blood banks and hospitals in specific regions to access the Intercept treatment of platelets components.
Cerus Corporation (NASDAQ:CERS) is awaiting FDA approval for the Intercept platelet system, which is already under the agency’s review. However, the company expects an approval decision earliest in the next year. In an article, Seeking Alpha states that the system is already prevalent in Europe for 12 years. Apart from this, it is widely accessed by more than 100 blood banks outside of the U.S.
Endemic In Caribbean
In Puerto Rico, as many as 1,000 positive Chikungunya infected patients have been recorded. The alarming situation has caused the local Health Department to issue administrative regulation which demands all blood donations to be quarantined for 72 hours, which are awaiting follow-up on donor records for acute infectious symptoms. It is ordered that in case no follow-up history about the donor is obtained, the blood components must be destroyed.
In the Caribbean region, dengue virus has been threatening as an endemic while Chikungunya virus was initially detected in February. The transmission and spread of both the viruses occur through mosquitoes, which are common in tropical climates. According to some earlier published findings, Intercept immobilization of >5.3 log dengue and >6.4 log Chikungunya infectious titers, both in surplus of noticed titers in asymptomatic donors.
