BOSTON, MASSACHUSETTS, U.S.A. — December 12, 2014 — Immunetics Inc., a leading clinical test provider, announced today that its newly commercialized BacTx® Rapid Assay will enable blood banks and transfusion centers to comply with the U.S. Food and Drug Administration’s (FDA) recently released draft guidance for the testing of platelets for bacterial contamination to enhance transfusion safety.
In its draft guidance for industry (December 2014), the FDA cited the risks of bacterial contamination of platelets and the critical need for means to mitigate these risks. In particular, FDA recommended that all pooled whole blood-derived platelets be subjected to rapid bacterial testing prior to transfusion. The agency also expressed concern over the safety of 4- to 5-day-old platelets – noting that the majority of sepsis incidents and fatalities were associated with these higher-risk units. Following recommendations of its Blood Products Advisory Committee, FDA suggested that testing of 4- to 5-day old units with a rapid, point-of-issue assay would be an effective way to detect and interdict contaminated platelet units.
The BacTx test from Immunetics is cleared by the FDA for the rapid testing of platelets for bacterial contamination prior to transfusion. It relies on a unique, patented detection chemistry that is specific for bacteria.
“The FDA has acknowledged the effectiveness of rapid testing in protecting patients from transfusion of contaminated platelets. The BacTx system is designed to detect the lower levels of bacteria of all types that can proliferate over time and may escape detection by other testing methods,” said John Yonkin, chief executive officer of Immunetics.
To facilitate compliance with FDA’s recent guidance, the BacTx test is designed for easy integration with lab workflows. “We realized that rapid bacterial testing for platelets would be a new activity for many labs, so assisting them with easy workflow and data management became a key goal of the BacTx system,” Yonkin said. “We had to ensure that BacTx delivered a highly sensitive test that was truly manageable within a demanding laboratory work environment.”
The BacTx test provides assay results and interpretation within 30 minutes. Test monitoring and interpretation rely on an automated random access analyzer and software with bar code scanner input that enable data entry, tracking, traceability and analysis for up to 8 samples per run.
The BacTx system meets AABB standard 126.96.36.199.1. and is cleared for quality-control testing of leukocyte-reduced apheresis platelets (LRAP) within 24 hours of transfusion, and pools of up to six units of leukocyte-reduced whole-blood derived platelets that are pooled within 4 hours of transfusion.
The FDA draft guidance also described a future pathway to extending platelet dating to 7 days from the current 5-day standard, contingent upon the use of an approved rapid test late in the storage period. Such an extension in dating will allow blood banks and transfusion centers to use platelets that would otherwise be discarded solely due to outdating, saving money and avoiding shortfalls in platelet inventory.“Immunetics is committed to supporting this initiative with the BacTx test,” said Yonkin.
For more information on the BacTx Rapid Assay, visit the Immunetics Website at http://immunetics.com/bactx.html or contact Immunetics at 1-617-896-9100 or toll-free at 1-800-227-4765.
Immunetics, Inc. offers state-of-the-art assay technology for infectious disease diagnosis and blood screening, and for more than 10 years, has been a leading innovator of tests for bacterial, viral, and parasitic diseases. The company produces and markets a range of infectious disease assay kits and instruments. The company has issued patents on its BacTx test for bacterial contamination of platelets. It has developed and markets other FDA-cleared products, including a test for Lyme disease, and is actively working on new tests for Babesiosis and Chagas disease — both of which are emerging risks to the blood supply. Immunetics is headquartered in Boston, Massachusetts. The company’s mission is to deliver better cost-efficient care through more accurate diagnosis. For more information, visit the Immunetics website at http://immunetics.com.