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Bacterial Contamination Risk

Bacterial contaminants in platelets and red blood cells represent the greatest lethal infectious risk in transfusion medicine today, and no practical methods are presently available to fully address this threat. Over 17 million patients receive in excess of 60 million units of these individual blood components annually in North America, Europe and Asia, and each of these components is at risk for bacterial contamination.

Enormous commitments of time and effort over the past 20 years have resulted in a dramatic reduction in the transmission of viruses through blood transfusion. For example, the risk of transmission of HIV per blood unit transfused has now been reduced to well below 1 in 1,467,0001. In contrast, the risk of being transfused a bacterially contaminated blood component is estimated by transfusion medicine experts to be 1 in 2,000 to 1 in 20,000 for platelets and red cells, respectively. This means that as many as 12,000 bacterially contaminated blood components may be transfused every year representing the single greatest source of fatalities attributable to infectious agents in transfusion medicine today. In recognition of this risk, the American Association of Blood Banks implemented a standard requiring all of its members implement methods to limit and detect bacterial contamination in platelets.

Contamination Risk Diagram
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In spite of the implementation of tests to combat this risk such as culture and other bacterial growth based detection methods, fatal transfusion reactions attributable to bacterial contamination still occur2,3. This is due to the unique detection challenge posed by bacteria – a challenge that can only be addressed with PGD technology.

1Zou A, Dorsey KA, Notari, EP, Foster GA, Krysztof DE, Musavi F, Dodd RY, Stramer SL. Prevalence, incidence, and residual risk of human immunodeficiency virus and hepatitis C infections among United States blood donors since the introduction of nucleic acid testing. Transfusion 2010; 50:1495-504

2Septic Transfusion Reactions Despite Implementation of Methods to Reduce Bacterial Contamination: Arjun Srinivasan, M.D., DHQP Centers for Disease Control, Presentation to the Advisory Committee On Blood Safety and Availability, Department of Health and Human Services, January 25, 2005

3Fatalities Reported to FDA Following Blood Collection and Transfusion Annual Summary for Fiscal Year 2010

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

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