New Blood Test Successfully Predicts Risk of Infection in Transplant Recipients

By Cellestis Limited, PRNE
Thursday, April 22, 2010

International guidelines support advances in immune monitoring

MELBOURNE, Australia, April 23, 2010 - 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(R)-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(R)) 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.

    CONTACT:
    George Dragovic
    Cellestis
    Phone: +61-3-8527-3543
    Email: gdragovic@cellestis.com

George Dragovic of Cellestis Limited, +61-3-8527-3543, gdragovic at cellestis.com

YOUR VIEW POINT
NAME : (REQUIRED)
MAIL : (REQUIRED)
will not be displayed
WEBSITE : (OPTIONAL)
YOUR
COMMENT :