MARLBOROUGH, Mass., March 15, 2016 /BusinessWire/ — Verax Biomedicaltoday announced that new FDA Draft Guidance for Industry for the control of bacterial contamination of platelets has been published, confirming that Verax’s PGD® test will fundamentally contribute to improving the safety of the nation’s platelet supply. Currently there is only one rapid test cleared as a Safety Measure for extending the shelf life of apheresis platelets from five to seven days and that test is the Verax PGD test.
The FDA Draft Guidance, titled Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion, recommends testing apheresis platelets in plasma or additive solution that have already been cultured with a secondary test like Verax’s PGD® Test on days 4 or 5 of unit life and affirms that the only way to achieve 7-day platelet dating of apheresis platelets in plasma is by performing secondary testing with an FDA-cleared test labeled as a Safety Measure on the day of transfusion. Results from a large, multi-center study demonstrated the ability of the Verax PGD® test to detect and interdict transfusion of bacterially contaminated platelets, thereby supporting FDA clearance of the PGD test as a Safety Measure. The guidance also recommends testing whole blood derived post-storage platelet pools and pre-storage pooled (AcrodoseTM) platelets with a rapid test like PGD. Taken together, these platelet types represent virtually the entire US platelet inventory.
“This draft guidance confirms what we have been saying for some time, that our PGD® test plays an integral role in improving platelet safety and extending platelet shelf life up to 7 days,” said Verax Biomedical CEO Jim Lousararian. “We believe this guidance will make blood banks and transfusion services across the country significantly more cost efficient and dramatically reduce the number of platelet units destroyed needlessly based on the previous 5-day dating limitation.”
At present approximately 90% of all platelets in the US are apheresis platelets that may now be extended in dating from 5 to 7 days with PGD testing. A 2011 Department of Health and Human Services report on blood utilization in the US reports that 12.8% of apheresis platelets outdate each year in the US at an average minimum cost of $550 per unit. This equates to a cost to the US healthcare system of a minimum of over $140 million annually.
“This is a very significant development in the drive to improve patient safety by reducing the risk of bacterial contamination in platelets” said Dr. Paul D. Mintz, Verax’s Chief Medical Officer. “And, the ability to move to 7 day platelet dating with Safety Measure testing in advance of final guidance helps make this possible immediately.”
The same Draft Guidance offers the option of utilizing pathogen reduction as an alternative to testing, but at present pathogen reduction is only approved for use with apheresis platelets in additive solution. These platelets represent less than five percent of the current platelet inventory in the United States. Pathogen reduction also reduces platelet survival and recovery according to an FDA assessment of the technology while dramatically increasing their cost to hospitals in a time of increasing healthcare budgetary concerns. Platelets treated by this technology are also presently limited to just 5 day dating.
The Verax PGD® test, based on proprietary technology developed by Verax, consists of an easy-to-use disposable test device and reagents that work together to detect the presence of bacterial contaminants in platelets. The test can be performed in minutes, takes only 30 minutes for a result and is designed for use in hospitals, cancer centers and other sites of care as a critical patient safety measure prior to transfusion. In normal usage, most users are able to test 12 or more units per hour.
Verax is the producer of the Platelet PGD Test, the only test for bacterial contamination in platelets granted a Safety Measure claim by the FDA. The test can now also be used to extend the dating of apheresis platelets in plasma, the most common platelet type transfused in the U.S., from 5 to 7 days. This dating extension offers the opportunity for significant cost savings to the blood banking community while preserving a critical life giving resource. For more information, visit www.veraxbiomedical.com
Joe Sanders, 617-771-8199
Sr. VP Marketing and Business Development