Circadian Launches First Diagnostic for LAM Lung Disease With U.S. Partner

• Circadian and Cincinnati Children’s Hospital Medical Center (“Cincinnati Children’s”) commences offering of first blood test diagnostic for LAM – a serious lung disease that is often undiagnosed.
• Number of tests expected to exceed 25,000 within the next few years.

Circadian Technologies (ASX.CIR) has announced today that in conjunction with Cincinnati Children’s Hospital Medical Center it has begun offering its LAM diagnostic, which is offered as a laboratory test compliant with CAP (College of American Pathologists) /CLIA regulations.

This is the first blood based diagnostic available to test for the disease lymphangioleiomyomatosis (LAM). The blood sample based diagnostic was developed by Cincinnati Children’s, using Circadian’s VEGF-D technology, 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.

LAM is a serious lung disease that causes shortness of breath and lung collapse. It affects mostly women, often striking in their 30s or child bearing years, and the only known treatment is a lung transplant.

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

The availability of the test, and subsequent increasing knowledge of the disease amongst the general medical community, is predicted to increase screening for LAM in patients, with the number of tests estimated to exceed 25,000 within the next few years.

Doctors in the U.S. can now order this test through the Translational Trials Development and Support Laboratory of Cincinnati Children’s.

Robert Klupacs, CEO of Circadian Technologies said he is very proud that the collaboration with Cincinnati Children’s has achieved its goal of making a test available that offers straightforward and accurate identification of LAM, which to date has been difficult and expensive to diagnose.

“LAM is a serious but often misunderstood or misdiagnosed disease, which has a huge impact on the quality of life for the women it affects. We are confident that with greater awareness and the availability of this test that more women who show symptoms or who have the TSC gene will be able to have LAM diagnosed early and better manage their condition.

“Circadian is very excited about the launch of this test. It is the first product to emerge from our extensive VEGF technology portfolio, and hopefully the first of many, to become available from the range of diagnostics in development by Circadian and our partners. Diagnostics are an important part of Circadian’s business that we are progressing in parallel to our drug discovery activity, as a source of early revenue and to complement our product portfolio.”

The findings of the diagnostic link between LAM and VEGF-D by the team of scientists at the University of Cincinnati (UC) and Cincinnati Children’s led by Dr. Lisa Young and Dr. Frank McCormack, Director of Pulmonary, Critical Care and Sleep Medicine at UC were published in the August 2010 edition of CHEST1.

Dr. McCormack said, “We are optimistic that 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.”

Cincinnati Children’s have commenced offering the diagnostic test for LAM in the United States. Circadian retains the rights to the rest of the world and is working towards approval in other markets.