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Circadian Partners with Cincinnati Children's Hospital to Develop Blood Test Diagnostic for Fatal Lung Disease


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Circadian Technologies has announced that it has partnered with Cincinnati Children's Hospital Medical Centre (CCHMC) to develop and market a blood test to diagnose LAM, a serious lung disease that strikes women, usually in their child bearing years.

The diagnostic is being developed following the discovery that high levels of vascular endothelial growth factor-D, or VEGF-D – to which Circadian owns intellectual property rights – holds the key to detecting the disease.

The test is expected to be available in the U.S. from early 2011, and Circadian will work with CCHMC and other groups throughout the world to make the test available in other global markets.

LAM, which is short for lymphangioleiomyomatosis, is a serious lung disease that affects women, causing shortness of breath and lung collapse. The disease occurs when an unusual type of cell invades the lungs and causes tissue destruction by creating holes or cysts in the lung. It can be fatal and the only known treatment is a lung transplant.

To date, LAM has been difficult and expensive to diagnose, usually requiring a biopsy or high resolution CT scan. Due to low awareness of LAM, the early symptoms are often mistaken for other respiratory conditions such as asthma, bronchitis or emphysema.

Although only a small number of patients have been diagnosed with LAM to date the recent discovery of a link between LAM and the genetic abnormality, Tuberous Sclerosis Complex (TSC), has led scientists to estimate that more than 250,000 women worldwide are unaware they have LAM.

The availability of this non-invasive diagnostic test may eliminate the need for a surgical lung biopsy to diagnose LAM, significantly improving the quality of life in women who may be suspected LAM sufferers. It will also be helpful in screening for LAM in women with TSC, a genetic disorder that causes tumours to form in many different organs. TSC is a risk factor for the development of LAM.

Robert Klupacs, CEO of Circadian Technologies said he is very proud to be working with the team from CCHMC to make a test available that offers straightforward and accurate identification of LAM.

"This test will be able to reduce, and hopefully, remove the need for surgical intervention for accurate diagnosis of LAM which we believe will have a huge impact on the quality of life for women who may have this terrible disease. Being able to provide an early indication of LAM, particularly in those who have the genetic disorder, TSC, should greatly assist in helping these patients to manage their condition."

"The development of this test adds to the portfolio of diagnostics in development by Circadian and our partners. Diagnostics is an important part of Circadian's business that is progressing in parallel to our drug development activity, as a source of early potential revenue and to complement our product portfolio."

The findings of the diagnostic link between LAM and VEGF-D were made by a team of scientists at the University of Cincinnati (UC) and CCHMC led by Dr. Lisa Young and Dr. Frank McCormack, Director of Pulmonary, Critical Care and Sleep Medicine at UC and were published in the August 2010 edition of CHEST(1).

Dr. Frank McCormack stated that "These findings are the result of a team effort by clinicians around the world to collect blood samples and clinical data from patients with very rare lung diseases.

"Through their efforts and the generosity of patients who participated, we are optimistic that this new diagnostic, serum VEGF-D, will join the ranks of diagnostic tests for lung disease, reduce the need for surgical lung biopsy and allow for intervention and trial recruitment earlier in the disease course."

Circadian controls exclusive worldwide rights to an extensive intellectual property portfolio enabling it to develop diagnostic tests to detect VEGF-D.

"We look forward to working with the Cincinnati team and other groups to make this test also available outside the United States in the near future," concluded Mr. Klupacs.
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