CLINICAL NEWS
15
Latest & Greatest
FDA Approves System
to Make Blood
Transfusions Safer
The U.S. Food and Drug Administration (FDA) approved the Intercept Blood
System, a new system designed to remove
viruses, bacteria, and other pathogens
from donated blood platelets. In an analysis of 844 subjects in 10 clinical studies
who received platelets using this new
system, treatment reduced the number
of a broad range of viruses, bacteria,
and other pathogens that may contaminate platelets, including HIV, hepatitis
B and C viruses, and West Nile virus.
The Intercept System – which was also
recently approved for the preparation of
plasma to reduce the risk of transfusiontransmitted infections – also reduced the
number of T cells to a level that lowers
the risk of transfusion-associated graftversus-host disease.
Source: FDA press release, December 19, 2014
Test to Confirm the
Presence of HTLV-I
and HTLV-II Receives
FDA Approval
The MP Diagnostics HTLV Blot 2.4, a
qualitative enzyme immunoassay test,
was recently approved as the first FDAlicensed supplemental test for human
T-cell lymphotropic virus-I/II (HLTV-I/
II). This test is intended for use as an
additional, more specific test for human
serum or plasm H