Immunetics BacTx® Test Helps Hospitals Meet FDA Proposed Changes in Platelet Bacteria Testing Practices

Immunetics today announced that the FDA has published updated Draft Guidance for Industry - “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion”. The proposed changes by the FDA in platelet bacteria testing practices cited the risks of bacterial contamination of platelets and the critical need for means to mitigate these risks. Immunetics BacTx^® Technology provides hospitals with a rapid, low cost, and proven solution to meet this new guidance.
The point-of-issue BacTx^® test allows hospitals to readily facilitate efficient testing of platelets with a rapid testing system for bacterial detection that meets the proposed FDA Guidance. The result is a safer platelet supply, providing transfusion services with a “last look” at the platelet unit just prior to transfusion.
Platelets are associated with a higher risk of sepsis and related fatalities than any other transfusable blood component. In the United States today, blood collection facilities must adhere to AABB Guidelines calling for every platelet to be tested using an FDA approved device. However, the risk of bacterial infection persists- the primary issue being sampling error, as most testing occurs early in the life of the platelet unit when bacteria counts may be too low to be captured during routine sampling. In the updated March 2016 Guidance document, the FDA indicates the need to improve the safety of platelet transfusions by secondary bacterial testing, and confirms that use of a rapid assay such as the BacTx^® test closer to the point of transfusion may mitigate these risks.

About Immunetics:
Immunetics Inc. offers state-of-the-art assay technology for infectious disease diagnosis and blood screening, and for more than ten years has been a leading innovator of tests for bacterial, viral, and parasitic diseases. Immunetics is headquartered in Boston. The company’s mission is to deliver better, cost-efficient care through more accurate diagnosis.