Health Care Professionals/Laboratory: Clinical Studies

• The utility of the ImmuKnow assay has been well characterized and validated

– Over 400,000 assays run

– 25 prospective and interventional studies in more than 1000 transplant recipients

– More than 120 clinical studies

• To date, global immune status monitoring has been used to:

– Identify kidney,² liver,¹ lung,³,⁴ and heart⁵ transplant patients with low immune
   response, which has the potential to lead to infection

– Define immunologic stability in various solid organ transplant patients⁵,⁶

– Longitudinally assess changes in transplant patients’ immune status, giving clinicians an
   additional tool in treatment optimization decisions¹,^5-7

• The ImmuKnow assay is FDA cleared and reimbursable

For more information, please contact our Medical Affairs department at 888.33.CYLEX, option 2, which can provide medical and scientific perspectives related to these and other clinical studies involving ImmuKnow.

1. Cabrera R, Ararat M, Soldevila-Pico C, et al. Using an immune functional assay to differentiate acute cellular rejection from recurrent hepatitis C in liver transplant patients. Liver Transpl. 2009;15:216- 222. 2. Sánchez-Velasco P, Rodrigo E, Valero R, et al. Intracellular ATP concentrations of CD4 cells in kidney transplant patients with and without infection. Clin Transplant. 2008;22:55-60. 3. Bhorade SM, Janata K, Vigneswaran WT, Alex CG, Garrity ER. Cylex ImmuKnow assay levels are lower in lung transplant recipients with infection. J Heart Lung Transplant. 2008;27:990-994. 4. Husain S, Raza K, Pilewski JM, et al. Experience with immune monitoring in lung transplant recipients: correlation of low immune function with infection. Transplantation. 2009;87:1852-1857. 5. Kiyosaki K, Kobashigawa J, Patel J, et al. The benefit of immune monitoring (Cylex): a review of 864 immune monitoring assays in heart transplantation. Presented at: The International Society for Heart and Lung Transplantation 29th Annual Meeting and Scientific Sessions; April 22-25, 2009; Paris, France; Abstract 511. 6. Humar A, Michaels M. American Society of Transplantation recommendations for screening, monitoring and reporting of infectious complications in immunosuppression trials in recipients of organ transplantation. Am J Transplant. 2006;6:262-274. 7. Augustine NH, Pasi BM, Hill HR. Comparison of ATP production in whole blood and lymphocyte proliferation in response to phytohemagglutinin. J Clin Lab Anal. 2007;21:265-270.

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