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Reimbursement Rate Nearly Tripled for Cylex's ImmuKnow® Assay

COLUMBIA, Md., Dec. 14, 2010 /PRNewswire/ -- Cylex Incorporated® today announced that the Centers for Medicare and Medicaid Services (CMS) nearly tripled the reimbursement for ImmuKnow®, the immune cell function assay FDA-cleared for the detection of cell-mediated immune response in populations undergoing immunosuppressive therapy for organ transplant.  This significant increase was granted in a time when the overall CMS clinical fee schedule experienced a comprehensive decrease in laboratory reimbursement rates.  


"We are pleased that our ongoing dialogue with CMS over the last two years resulted in a substantial increase to ImmuKnow reimbursement.  In our view, this change sends a clear message that ImmuKnow is an established, accepted technology that is critical to providing better patient care," stated Brad L. Stewart, President and CEO of Cylex.  The ImmuKnow assay is used around the world to help physicians assess the immune status of transplant patients as it relates to over- and under-immunosuppression.

Increasing by 267% to $191.19 over the 2009 rate, $71.58, the new rate becomes effective January 1, 2011.

According to Stephen Bloch, MD, a member of Cylex's board, "We believe the best option for a transplant patient undergoing immunosuppression therapy is to receive individualized patient management from their clinicians."  Dr. Bloch added, "These changes in reimbursement reduce a financial challenge for those transplant professionals seeking to provide such individualized management for their patients."  

ImmuKnow complements immunomodulatory therapy and helps physicians manage immunosuppression in posttransplant patients, thereby facilitating reduced risks of infection and rejection by:

  • Providing a global marker of immune function and response to immunosuppression at the cellular level
  • Detecting changes in CD4 cell ATP production
  • Helping to define a range of stable immune function for each patient
  • Providing critical, actionable information on an ongoing, individual basis when used longitudinally to continually assess immune status (in combination with other routine monitoring tests)

Medicare and most private insurance carriers cover and reimburse for ImmuKnow testing, facilitating physician access to this important biomarker of immune function.

About ImmuKnow

ImmuKnow is a noninvasive biomarker of immune function that assesses cellular immune status by detecting cell-mediated immune response in populations undergoing immunosuppressive therapy for organ transplant.  It measures the concentration of adenosine triphosphate (ATP) released from circulating CD4 cells following in vitro cell stimulation with phytohemagglutinin (PHA).  The ImmuKnow assay is a qualitative assay and does not directly quantify the level of immunosuppression.  Results of the ImmuKnow assay should be used in conjunction with clinical presentation, medical history, and other clinical indicators when assessing the immune status of any individual patient.

About Cylex, Inc.

Cylex is the commercial, global life sciences company leading the development and manufacture of in vitro diagnostic assays that measure cellular immune function.  The Company's unique technology provides an innovative platform allowing detection of cell-mediated immunity.  This presents an exciting opportunity for the development of additional assays for diseases, and companion diagnostics for treatments, that affect the immune system.  The Company is based in Columbia, MD USA.  For more information, visit

SOURCE Cylex, Inc.
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