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Blood Matters.TM

INTERCEPT ® Blood System for PlateletsPathogen Reduction System

The need for reduced risk and blood availability.

Patients entrust blood centers and hospitals to provide safe blood when they need it, but the continued risk of transfusion transmitted infections (TTI), as well as blood shortages, have brought global attention to the importance of blood safety and availability.1-12

Bacterial contamination of platelet components remains the leading transfusion transmitted infection (TTI) risk to the blood supply which can lead to sepsis and death.1

In fact, FDA has made clear through a pending guidance that 8mL/aerobic primary culture alone is insufficient to protect the platelet supply, and has called for the implementation of new measures to minimize risk.1 Industry concerns regarding such measures include platelet supply constraints, as well as operational and compliance challenges that hospitals may face with implementation of secondary testing.13,14

Access to safe blood contributes to healthy patient outcomes.


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Enable Blood Centers to:

• Comply with FDA’s pending guidance on minimizing bacterial contamination.1

• Maintain control of platelet manufacturing unlike secondary bacterial testing measures that are likely to be performed in a hospital setting.

• Avoid false positive results and associated retesting that can be inherent with testing.

• Replace bacterial detection, gamma irradiation, CMV testing and Zika virus testing in apheresis platelet components.15-18

Enable Hospitals to:

• Obtain transfusion-ready platelet products that comply with the FDA draft guidance without secondary testing, resulting in minimal operational disruption to hospitals.1,13,14

• Reduce the risk of bacterial contamination and associated sepsis in patients, a cost savings that can range from ~$20K-180K per sepsis case.15,19

• Reduce infectious risk beyond bacteria, with mitigation of TTI due to viruses and parasites, as well as TA-GVHD due to T-Cells.15

• Be eligible for CMS reimbursement.20

Reduce infectious risk while providing transfusion-ready platelets to patients.

Effective in reducing transfusion-transmitted infections (TTI),15 pathogen reduction for platelet components provides a solution to blood centers and hospital clients that ultimately benefits patients who need it most.

Not only does pathogen reduction comply with FDA’s pending guidance on addressing bacterial contamination,1 it reduces risk beyond bacteria with mitigation of TTI due to viruses and parasites, as well as TA-GVHD due to T-Cells.15 Furthermore, pathogen reduction can be used as an alternative to bacterial testing, CMV testing, babesia testing and gamma irradiation which helps streamline operations.15-18

INTERCEPT Platelets

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Targeting DNA and RNA to prevent pathogen proliferation.

The INTERCEPT System uses amotosalen - a well characterized photoactive compound that specifically targets DNA and RNA - and UVA illumination to irreversibly cross-link nucleic acids. In doing so, the INTERCEPT treatment blocks replication of viruses, bacteria, and parasites, rendering them inactive.15

A proactive approach to blood safety.

1 2 3

Amotosalen targets nucleic acids, and intercalates or “docks” between nucleic acid base pairs.

UVA illumination activates amotosalen, initiating permanent cross-links between the helical strands.

Cross-linking prevents further replication and inactivates the pathogen and/or leukocyte.

Amotosalen

Targeting

Intercalates into Regions of DNA and RNA

Blocks Replication, Transcription and Translation

Crosslinks upon UVA Illumination

UV Illumination


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Broad spectrum pathogen reduction.* The INTERCEPT Blood System is a proactive approach to reducing transfusion-transmitted infectious (TTI) risk through the broad spectrum inactivation of viruses, bacteria, parasites, and leukocytes that can be found in platelet components. Robust inactivation is achieved, with ≥4 log reduction for most clinically relevant pathogens when using the INTERCEPT System.15

Protozoa

T-Cells/ Leukocytes

Human T-cells 4 4

*There is no pathogen inactivation process that has been shown to eliminate all pathogens. Certain non-enveloped viruses (e.g., HAV, HEV, B19 and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process.

Plasmodium falciparum ≥6.6 >6.5

Babesia microti ≥4.9 >4.5

Trypanosoma cruzi ≥7.8 >8.4

Log Reduction(pfu or cfu/mL)a

Escherichia coli ≥6.3 >5.9

Yersinia enterocolitica ≥5.9 >6.3

Klebsiella pneumoniae >6.2 >6.2

Serratia marcescens ≥6.7b >7.1

Staphylococcus epidermidis

≥6.4 >6.5

Staphylococcus aureus ≥6.6 ≥6.5

Streptococcus pyogenes ≥6.8b >6.1

Bacillus cereus (vegetative)

≥5.5 ≥5.6

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

Platelets in 65% PAS-3/ 35% plasma

Platelets in 100% plasma

BacteriaGram Negative, Gram Positiive, Spirochetes

Log Reduction(cfu/mL)a

Log Reduction

VirusesEnveloped Non-enveloped

HIV-1, cell-associated ≥5.4 ≥4.7

DHBV (model virus for HBV)

≥4.8 ≥4.3

BVDV (model virus for HCV)

≥4.1 >3.5

HTLV-I 4.7 c

HTLV-II ≥5.1 c

West Nile virus (WNV) ≥6.3 >6.3

Chikungunya virus (CHIKV)

≥5.7 >6.5

Dengue virus ≥4.3 3.6

Cytomegalovirus (CMV) ≥4.9 c

Pseudorabies virus (model for CMV)

c ≥4.2

Influenza A virus ≥5.9 c

Bluetongue virus (model non-enveloped virus)

5.2 4.4

Log Reduction(pfu/mL)a

a. Based on input titer and post-treatment titer in 1 mL. b. Based on culture of full platelet unit (300 mL). c. Not tested

For a full list of pathogens, see package insert.





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The INTERCEPT Blood System is comprised of disposable kits and a UVA Illuminator, and is compatible with Amicus® apheresis platelet components suspended in PAS-3 or Trima® apheresis platelet components suspended in 100% plasma.15

The use of the INTERCEPT Blood System for Platelets entails four easy steps.

UVA IlluminationDevice

CollectedPlatelets

STEP 1Amotosalen

STEP 2Illumination

STEP 3CAD

STEP 4Final Storage

Integrated Container Set

SCD

*

*Removal of unreacted amotosalen via Compound Adsorption Device (CAD)


A straightforward process.

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A commitment to enhancing your success. We work with our customers as true partners to optimize technologies and initiate best practices to improve blood supply and safety.

Through our years of experience, we’ve gained a uniquely deep and broad perspective on all aspects of the blood supply chain, from operational processes to transfusion practices. We apply this expertise in every interaction to ensure smooth implementation and to help our blood center and hospital customers become more proficient in achieving our shared goal of improved patient care.

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Contraindications12 Contraindicated for preparation of platelet components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of platelet components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.

Warnings and Precautions12 Only INTERCEPT Processing Sets for platelets are approved for use in the INTERCEPT Blood System. Use only the INT100 Illuminator for UVA illumination of amotosalen-treated plasma or platelet components. No other source of UVA light may be used. Please refer to the Operator’s Manual for the INT100 Illuminator. Discard any platelet components not exposed to the complete INT100 illumination process.

Tubing components and container ports of the INTERCEPT Blood System Platelets contain polyvinyl chloride (PVC). Di(2-ethylhexyl)phthalate (DEHP) is known to be released from PVC medical devices, and increased leaching can occur with extended storage or increased surface area contact. Blood components will be in contact with PVC for a brief period of time (approx. 15 minutes) during processing. The risks associated with DEHP released into the blood components must be weighed against the benefits of therapeutic transfusion. PLATELETS: Pulmonary events: Acute Respiratory Distress Syndrome (ARDS) INTERCEPT processed platelets may cause the following adverse reaction: Acute Respiratory Distress Syndrome (ARDS) An increased incidence of ARDS was reported in a randomized trial for recipients of INTERCEPT processed platelets, 5/318 (1.6%), compared to recipients of conventional platelet components (0/327). Monitor patients for signs and symptoms of ARDS.

© 2019 Cerus Corporation. Cerus, INTERCEPT Blood System and INTERCEPT are registered trademarks of Cerus Corporation. MKT-EN 00141-01 v4.0.

GLOBAL HEADQUARTERS | 1220 Concord Avenue | Concord, CA US 94520 | 855.835.3523

www.cerus.com | www.intercept-usa.comRx only. See package insert for full prescribing information.Amicus is a registered trademark of Fenwal Inc. Trima is a registered trademark of Terumo BCT, Inc.

References

1. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Draft Guidance for Industry, December 2018.

2. Kleinman S et al. Transfusion 2013;53:1603-1618.

3. Stramer SL, Hollinger FB, et al. Transfusion 2009;49(Suppl 2):1S-29S.

4. Rasongles P, et al. Transfusion 2009;49:1083-91.

5. Succo T et al. Euro Surveill. 2016 May 26;21(21).

6. Gjenero-Margan I et al. Euro Surveill. 2010 Sep 2;15(35).

7. Danis K et al. Euro Surveill. 2011 Aug 25;16(34).

8. Barzon L et al. Euro Surveill. 2009 Aug 6;14(31).

9. Schmidt M et al. Transfus Med Hemother 2014;41:10-17.

10. “FDA. Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components. FDA Guidance for Industry July 2018.

11. ABC News; “The Nation Has a Major Blood Shortage,” September 19, 2018.

12. The INTERCEPT Blood System for Platelets Package Insert, Cerus Corporation; July 17, 2018.

13. AABB/America’s Blood Centers/American Red Cross joint letter to FDA on December 2018 Draft Guidance, Docket No. FDA-2014-D-1814, March 2019.

14. American Red Cross letter to FDA on December 2018 Draft Guidance, Docket No. FDA-2014-D-1814, February 2019.

15. The INTERCEPT Blood System for Platelets Package Insert, Cerus Corporation; July 17, 2018.

16. “Standards for Blood Banks and Transfusion Services,” AABB, 31st edition, 2018.

17. “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components. FDA Guidance for Industry, July 2018.

18. “Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis. FDA Guidance for Industry, May 2019.

19. Definitive Health Care Medicare Database Sepsis Report, 2017.

20. Centers for Medicare and Medicaid Services (CMS): https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html.

INTERCEPT ® Blood System for Platelets, Pathogen Reduction System

blood matters. - intercept blood system...tubing components and container ports of the intercept...

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