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Roche complements hemostasis portfolio with the Multiplate & #174; analyzer

Thu, 07/05/2012 - 3:22am
Roche

Rotkreuz/Switzerland, July 5, 2012

Personalized anti-platelet therapy and stratified bleeding risk with unique diagnostic solution

Roche (SIX: RO, ROG; OTCQX: RHHBY) started the distribution of the Multiplate analyzer, a medical solution for the rapid determination of a patient's platelet function. The Multiplate analyzer aids health professionals to predict a patient’s thrombotic1,2,3 and bleeding risk3,4  and thus enables them to tailor anti-platelet therapies and to stratify patients at risk of bleeding during and after surgery5. Multiplate truly represents Roche’s ambition for improved clinical decision making, as the compact and easy to use bench-top system can support physicians in making improved clinical decisions in cardiology, surgery and intensive care.3,6,7

“Multiplate ideally complements our new hemostasis portfolio as it combines proven medical benefit to health professionals with striking innovation for the clinical laboratory. Our roadmap in hemostasis diagnostics will deliver a continuing series of leading products in the coming years and Multiplate is our first tangible element that demonstrates the swift implementation of our new hemostasis strategy”, states Colin Brown, head of Roche Professional Diagnostics. The Multiplate analyzer was recently acquired with Roche’s takeover of Verum Diagnostica, an international leader in platelet function testing.

Patients with high residual on-treatment reactivity have been shown to be at increased risk of stroke2 and recurrent ischemic events.5,7,8 Platelet inhibitors such as Aspirin® and clopidogrel are used to ensure blood fluidity and to minimize the formation of thrombi. But not all patients respond well to anti-thrombotic agents. For example, up to 25% of patients only respond inadequately to a treatment with the platelet antiaggregant clopidogrel.9 They are termed non-responders. The identified increased risk can be reduced by switching these patients to other anti-platelet therapies that have been shown to reduce recurrent events.5,8

With patients under antiplatelet therapy like Aspirin, it is crucial to assess the patients’ bleeding risk before surgical impacts. As Aspirin is commonly known for a tendency of mild bleeding, the treatment of patients with additional anti thrombotic agents such as clopidogrel showed a perioperative risk of bleeding. Multiplate supports health professionals with a precedent patient monitoring to determine if the individual is at risk of severe bleeding when treated with specific anti-thrombotic agents. Several studies have shown that Multiplate analysis can successfully determine the effectiveness of anti-platelet drugs like Aspirin10, as well as anti-platelet treatment options like clopidogrel and prasugrel11.

A major challenge in patients with intravascular stent implants is that the turbulent surface of the implant can activate platelet formation. Consequently, a pharmacological platelet inhibition is crucial to prevent stent thrombosis. In clinical practice a dual platelet aggregation treatment is currently recommended to avoid thrombi forming. However, challenges with non-responders on specific anti thrombotic agents exist. In one of the largest clinical investigations to state, poor clopidogrel responders had a 9.4 fold higher risk of stent thrombosis than normal responders7, whilst the proportion of patients resistant to Aspirin is about one out of ten. Several studies showed that routine tailoring of anti-platelet therapy using Multiplate testing has the potential to significantly reduce the incidence of major adverse ischemic events after coronary stent implantation.5,8,12

Laboratory coagulation is estimated to be the fifth largest market in professional diagnostics globally. By the year of 2015, Roche expects a significant growth in the field of coagulation diagnostics of above 5% in a today global 1.3 billion USD market. First deployed in the European, Middle-East and Asian region13 the system comes with six CE marked reagents, including ADPtest, ASPItest, TRAPtest, COLtest, RISTOtest and ADPtest HS. By providing a turnaround time of whole blood testing on five simultaneous channels in 10 minutes, the Multiplate analyzer leads the industry benchmark available today.

References:

1)Orban, M. et al. Massive thrombus burden with recurrence of intracoronary thrombosis early after stenting and delayed onset of prasugrel action in a patient with ST-elevation myocardial infarction and cardiac shock. Thromb Haemost 2011; 106:

2)Schulz, S. et al. (2010). Platelet response to clopidogrel and restenosis in patients treated predominantly with drug-eluting stents. Am Heart J. Aug; 160(2):355-61

3)Sibbing, D. et al. (2010). Platelet aggregation and its association with stent thrombosis and bleeding in clopidogrel-treated patients: initial evidence of a therapeutic window. J Am Coll Cardiol. Jul 20; 56(4):317-8

4)Ranucci, M. et al. (2011). Multiple electrode whole-blood aggregometry and bleeding in cardiac  surgery patients receiving thienopyridines. Ann Thorac Surg. Jan; 91(1):123–9

5)Siller-Matula, J.M. et al. (2012) Personalized antiplatelet treatment after percutaneous coronary intervention: The MADONNA study. Int J Cardiol.  May 30. [Epub ahead of print]

6)Görlinger, K. et al. (2011). First-line therapy with coagulation factor concentrates combined with point-of-care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery: a retrospective, single-center cohort study. Anesthesiology. 2011 Dec; 115(6):1179-91. PubMed PMID: 21970887.

7)Sibbing, D., Braun, S., Morath, T., Mehilli, J., Vogt, W., Schömig, A., Kastrati, A., von Beckerath, N. (2009). Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. Mar 10; 53(10):849-56

8)Sibbing D., Mayer K., Bernlochner I. et al. (2012) Platelet function testing guided use of prasugrel in patients with high on-clopidogrel treatment platelet reactivity reduces the risk of early stent thrombosis. J. Am. Coll. Cardiol.; 59;E265.

9)Giorgi, M. A. et al. (2010). Nonresponders to clopidogrel: pharmacokinetics and interactions involved. Expert Opin PharmacotherOct; 11(14):2391-403.

10)Jámbor, C. et al. (2009). Whole blood multiple electrode aggregometry is a reliable point-of-care test of aspirin-induced platelet dysfunction. Anesth Analg.; 109(1):25-31

11)Bernlochner, I. et al. (2012). A prospective randomized trial comparing the recovery of platelet function after loading dose administration of prasugrel or clopidogrel. Platelets. Feb 28

12)Hazarbasanov, D., Velchev, V., Finkov, B., Postadjian, A., Kostov, E., Rifai, N., Aradi, D. (2012). Tailoring clopidogrel dose according to multiple electrode aggregometry decreases the rate of ischemic complications after percutaneous coronary intervention. J Thromb Thrombolysis. Jan 15 [Epub ahead of print]

13)Countries include France, Germany, UK, Korea, Spain, Portugal, Italy, Greece, Hungary, Poland, South Africa, Turkey, Egypt, Israel, Saudi Arabia, Hong Kong and Singapore

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

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