New Blood Test Successfully Predicts Risk of Infection in Transplant Recipients

MELBOURNE, Australia, April 23 /PRNewswire/ -- New international guidelines published in the journal Transplantation reinforce the use of a new type of blood test to assess cytomegalovirus (CMV) risk in solid organ transplant recipients (i.e. transplant recipients).  This blood test, QuantiFERON®-CMV (QF-CMV), is the first commercially-available blood test to allow physicians to monitor a person's risk of CMV disease.  Most commonly used in the transplant setting, QF-CMV may predict which transplant recipients are at increased risk of CMV disease after transplant surgery.

"For transplant recipients whose immune systems are already compromised by anti-rejection medications, the emergence of immune monitoring of CMV-specific T-cell responses in transplant medicine is an exciting development," said Assoc Prof Atul Humar, Director of Transplant Infectious Diseases, Department of Medicine, University of Alberta, Canada. "Immune monitoring may potentially allow physicians not only to gauge a patient's risk of developing post-transplant CMV disease, but also to assist in determining the most appropriate management pathway on an individual, patient-by-patient basis."

About CMV Testing and Immune Monitoring in Transplant Recipients

CMV is the most important infectious cause of post-transplant illness and death,  affecting approximately half of all transplant recipients. CMV disease leads to increased resource utilization and total transplantation program cost. Although preventative therapies are available for CMV and have been shown to be effective in preventing CMV disease, many transplant recipients still develop CMV disease in the months immediately after the end of their therapy. Current standard practice is to assess CMV status of both donor and recipient prior to transplantation.  A serology test is usually used for this pre-transplantation assessment. In a post-transplantation setting, where serology tests are limited because they cannot diagnose "active" CMV disease, CMV testing is most commonly completed using tests that detect the presence of the virus (i.e. viral load testing). Such tests are currently used to guide patient care and treatment.

Current guidelines indicate that monitoring transplant recipients' cellular immune responses to CMV can help a physician predict which transplant recipients are at increased risk of developing CMV disease.  A physician's ability to monitor the CMV immune status of transplant recipients may be useful in guiding the prevention and treatment of CMV disease after transplantation.

About the International Guidelines

The recently-published "International Consensus Guidelines on the Management of Cytomegalovirus in solid organ transplantation," the first-ever such guidelines, suggest that an ideal immune monitoring assay should assess the quantity and function of a transplant recipient's CD-4+ and CD-8+ T-cells and that such an assay should also:

• Be able to measure interferon-gamma (IFN-gamma)
• Be simple to perform, cost-effective, and reproducible
• Have a rapid turnaround time,
• Allow for specimens to be easily shipped to specialized referral laboratories.

About the QuantiFERON-CMV test

QF-CMV, a simple blood test, meets virtually all the criteria specified by the guidelines.  This new monitoring tool measures a person's CD-8+ T-cell immune response to CMV. It is the only standardized, commercially-available immune monitoring assay, specific for CMV.

Studies now highlight that monitoring a patient's level of immunity to CMV using QF-CMV could help guide the optimal duration of costly CMV preventative therapy in high-risk patients.

QF-CMV is a major advance in the management of CMV disease risk in transplant recipients. In this setting, QF-CMV is particularly useful for:

• Predicting the likelihood of CMV disease in high risk populations.
• Guiding the clinical and therapeutic management of high-risk patients.
• Decreasing the incidence of late-onset CMV disease and associated healthcare costs.

About Cellestis Limited

Cellestis Limited, a listed Australian biotechnology company founded in 2000 in Melbourne, Australia, develops and manufactures the QuantiFERON-CMV test, a breakthrough blood test for monitoring cytomegalovirus infection and disease, and the QuantiFERON-TB Gold In-Tube (QFT®) test for tuberculosis infection. Using its patented QuantiFERON technology, Cellestis develops diagnostics tests that measure immune function for diseases with an unmet medical need.

QuantiFERON-CMV is sold in Europe by Cellestis GmbH (Germany); and in Australia and Asia by Cellestis International Pty. Ltd. (Australia). QuantiFERON-CMV may also be available through commercial partners in Japan, Europe, the Middle East and other countries worldwide. QuantiFERON-CMV is not US FDA-approved and is available for investigational use only in the US. QF-CMV is not a test for CMV infection.

Visit www.cellestis.com  to view full details including references regarding QuantiFERON-CMV.

SOURCE Cellestis Limited

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