Open Nav

News

FDA Clearances Allow Implementation of 7-Day Platelets in the U.S. with the Platelet PGD Test

MARLBOROUGH, MA (October 20, 2015)— Two recent FDA clearances of seven-day storage containers from the largest suppliers of platelet collection systems in the United States - Fresenius Kabi and Terumo BCT - allow for seven-day platelet dating in the U.S. when used in conjunction with the Verax Platelet PGD Test, Verax announced today. Both clearances are for the extension of platelet dating from the previous limit of five days to seven days when platelets collected using Fresenius Kabi or Terumo BCT plateletpheresis systems are tested using an FDA-cleared "safety measure" test.

In light of these developments, an educational symposium in the formal program at the upcoming AABB annual meeting - the largest annual gathering of blood bankers in the world - will be devoted to seven-day dating of platelets.

Before these clearances, platelets had been limited to a shelf life of five days before expiration due to the risk of bacterial contamination. According to published Department of Health and Human Service data, 12 percent of apheresis platelets are discarded annually due to outdating.

"This not only wastes a precious life-giving resource," said Jim Lousararian, CEO of Verax Biomedical. "It also costs the U.S. health care system millions of dollars a year."

These new product clearances allow the extension of platelet dating when platelets stored in these containers are tested with a bacterial detection device labeled as a "safety measure." The Verax PGD test is the first and only bacteria-detection device for platelets to be designated as a "safety measure" by the FDA. Verax received this clearance in September 2011. A study that year inTransfusion found the Verax test can prevent the transfusion of bacterially contaminated platelets which may cause sepsis or death.

"The ability to extend platelets to a seven day shelf life is an exciting development for the blood-banking community," said Lousararian. "The FDA has taken a proactive step in clearing a pathway for platelets that are not only safer, but also more readily available due to extended dating."

"The reduction in outdating alone can fund the minimal cost of testing," said Dean Gregory, president, Medical Devices, for Fresenius Kabi USA. "This is a test that improves safety and lowers health care costs at the same time."

Platelets are the components of blood that help control bleeding. They are used in the treatment of cancers, compromised immune systems, organ transplant, blood disorders, and severe trauma. Platelets are stored at room temperature.

About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.

About Verax Biomedical
Verax Biomedical Inc. is a leading developer of rapid tests for detecting bacterial contaminants in blood cells and tissue. The privately held company was founded in 1999. Its headquarters and laboratory facilities are in Marlborough, Massachusetts. For more information, visit www.veraxbiomedical.com.

The PGD testing system

The Company's first product is the Platelet PGD Test – a rapid test for the detection of bacterial contamination in platelets.

Learn More