Proven Efficacy Against over 40 Clinically Relevant Pathogens1

Cerus Final Intercept United States 3

The INTERCEPT® Blood System for Platelets, pathogen reduction system, provides robust, broad spectrum reduction, reducing the risks of transfusion-transmitted infection (TTI), including sepsis, and as an alternative to gamma irradiation for prevention of transfusion-associated graft versus host disease (TA-GVHD).

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What is log reduction?

In terms of 1 log, reduction means a 10 fold reduction in the number of live bacteria.

For example:

1 log reduction would be reducing the amount of bacteria by 90%
2 log reduction would be reducing the amount of bacteria by 99.0%
4 log reduction would be reducing the amount of bacteria by 99.99%
5 log reduction would be reducing the amount of bacteria by 99.999%

A log reduction of at least 4 is required by the FDA to consider that a given pathogen has been inactivated.


Inactivation data by pathogen type:

bacteria- Bacteria
(gram-negative, gram-positive)
Log Reduction1 (cfu/mL)a,b
Platelets in
65% PAS-3/
35% plasma
Platelets in
100% Plasma
Klebsiella pneumoniae  >6.2 >6.2
Escherichia coli ≥6.3 >5.9
Serratia marcescens ≥6.7c >7.1
Pseudomonas aeruginosa ≥6.7 ≥6.7
Salmonella choleriaesuis 6.2 >5.9
Enterobacter cloacae >6.6 >6.8
Yersenia enterocolitica ≥5.9 >6.3
Staphylococcus epidermidis ≥6.4 >6.5
Staphylococcus aureus ≥6.6 ≥6.5
Listeria monocytogenes ≥6.3c >6.6
Corynebacterium minutissimum ≥5.3 >6.4
Streptococcus pyogenes ≥6.8c >6.1
Bacillus cereus (vegetative) ≥5.5 ≥5.6
Bacillus cereus (spore forming) 3.7c d
Bifidobacterium adolescentis ≥6.0 d
Clostridium perfringens (vegetative) ≥6.5 >6.0
Propionibacterium acnes ≥6.5 >6.7
Treponema pallidum (Syphilis) ≥6.4 >6.3
Borrelia burgdorferi (Lyme disease) ≥6.8 >4.1
     
virus- Virus
(enveloped and non-enveloped)
Log Reduction1 (pfu/mL)a
Platelets in
65% PAS-3/
35% plasma
Platelets in
100% Plasma
HIV-1 IIIB, cell-associated ≥5.4 ≥4.7
HIV-1 IIIB, cell-free ≥5.6 d
HIV-1 Z84 (clinical isolate) ≥3.3 d
HIV-2 CLB-20 (clinical isolate) ≥2.4 d
DHBV (model virus for HBV) ≥4.8 ≥4.3
BVDV (model virus for HCV) ≥4.1 >3.5
HTLV-I 4.7 d
HTLV-II ≥5.1 d
West Nile virus (WNV) ≥6.3 >6.3
Chikungunya virus (CHIKV) ≥5.7 >6.5
Dengue virus (DENV) ≥4.3 3.6
Cytomegalovirus (CMV) ≥4.9 d
Pseudorabies Virus (model for CMV) d ≥4.2
Influenza A virus ≥5.9 d
Calcivirus (model non-enveloped virus) 2.1 0.9
Adenovirus ≥4.9 ≥5.3
Bluetongue virus (model non-enveloped virus) 5.2 4.4
     
parasite- Protozoan Parasite Log Reduction1 (pfu or cfu/mL)a
Platelets in
65% PAS-3/
35% plasma
Platelets in
100% Plasma
Plasmodium falciparum ≥6.6 >6.5
Babesia microti ≥4.9 >4.5
Trypanosoma cruzi ≥7.8 >8.4
Leishmania mexicana
(metacyclic promastigote stage)
≥5.0 d
     
 leukocyte 80 80 Leukocyte Log Reduction1
Platelets in
65% PAS-3/
35% plasma
Platelets in
100% Plasma
Human T-Cells 4.0 4.0
     

For a full list of pathogens, see Package Insert.

a. Based on input titer and post-treatment titer in 1 mL, data obtained in platelet components in PAS-3 or plasma compnents

b. Study in progress

c. Based on culture of full platelet unit (300mL).

d. Not tested

  1. INTERCEPT Blood System for Platelets [Package Insert]. Concord, CA: Cerus Corporation; July 17, 2018.