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  • Cellmid Licensees Advance Commercialisation Of Lung, Bladder Tests 0 comments
    Mar 25, 2013 9:28 PM

    Cellmid (ASX: CDY) licensee Quest (Celera) has validated its lung cancer test, incorporating Cellmid's midkine technology, on the Luminex commercial platform.

    Luminex is widely used by pathology labs internationally, and should provide the ideal platform for product launch.

    The next step is clinical validation, which is already underway.

    Samples obtained from the National Cancer Institute sponsored chest X-Ray screening Prostate, Lung, Colorectal and Ovarian Trial will be used to demonstrate clinical accuracy of the test.

    Quest (Celera) continues to use midkine in its lung cancer tests, particularly for the diagnosis of indeterminate pulmonary nodules identified through CT scan or chest x-ray.

    Lung cancer is the leading cause of cancer death in the United States.

    Currently CT scans are performed to diagnose lung cancer, however these are expensive, lack the required accuracy and have a poor safety profile.

    Quest (Celera) partnership

    Cellmid signed a licence agreement with Quest (Celera) in October 2009 under which Quest would include midkine as one of the biomarkers in its lung cancer tests.

    The licence covers the use of midkine for the early diagnosis, prognosis, disease monitoring and management of lung cancer.

    The terms of the agreement provide for a milestone payment at the time of regulatory clearance for the lung cancer test, and royalties to be paid semi-annually.

    Pacific Edge

    Cellmid licensee Pacific Edge recently received CLIA registration of its Pennsylvania labs, which clears the way for the launch of its bladder cancer test, Cxbladder, in the U.S.

    This is a major commercial milestone for Pacific Edge as the CLIA registration means that it can roll-out a sales and marketing program around the product within the next few months.

    Pacific Edge expects revenues to grow gradually during 2013.

    Bladder cancer is one of the most common forms of malignancy. In the United States around 1 million patients present annually with haematuria, of which 68,000 are diagnosed with bladder cancer.

    Once treated, patients currently undergo frequent, painful and expensive cystoscopies (urethral endoscopies) to monitor reoccurrence.

    Pacific Edge's Cxbladder has the potential to replace cystoscopy over time as a preferred method of patient monitoring tool.

    Cxbladder has demonstrated 100% sensitivity and 85% specificity in late stage bladder cancer in clinical studies to date.

    This specificity is expected to increase in a monitoring setting. The test can also be used to differentiate between high and low grade cancers.

    Cxbladder was the subject of a comparative study of 485 patients and it outperformed other commercially available bladder cancer tests.

    Importantly, it has identified 20 cases of bladder cancer that were not identified by cystoscopy during clinical work-up.

    Maria Halasz, chief executive officer of Cellmid, said Pacific Edge is a great example of a small diagnostic company making a major difference in the way cancer is diagnosed, monitored and managed.

    The licence between Cellmid and Pacific Edge, which was agreed to in 2010, provides for a milestone fee payable in shares, which is due on the first sale of Cxbladder in the U.S.

    Royalties on revenues are expected to be paid to Cellmid semi-annually.

    Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX "Small and Mid-cap" stocks with distribution in Australia, UK, North America and Hong Kong / China.

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