Lab21 to provide AdnaGen’s tumour cell detection system UK and Ireland

26 August 2009

Lab21 Ltd and AdnaGen AG have entered into an exclusive service and distribution agreement for AdnaGen’s proprietary circulating tumour cell diagnostic assays in the United Kingdom and Ireland. These tests are based on the capture of circulating tumour cells (CTCs) from blood and subsequent detection of tumour-associated biomarkers.

Cancer diagnostics is a fast evolving and rapidly growing segment of in-vitro diagnostics. The high prevalence and mortality rates rank cancer amongst the world’s most disabling and deadly diseases. Cancer is the second most deadly condition, affecting over 25 million people worldwide, with more than 10 million new cases diagnosed worldwide annually.

The cost of treating cancer creates a serious pressure on global healthcare budgets. These data prime the need for improved diagnostics that either provide a diagnosis at an earlier stage or assist in better therapy management.

The AdnaTest products for detection and analysis of CTCs from metastatic breast cancer and metastatic colon cancer are tools to improve disease prognosis and patient management. The tests rely on immunomagnetic selection of tumour cells from blood followed by detection of tumour-associated biomarkers using RT-PCR. The proprietary AdnaGen approach has the clear advantage that it does not solely rely on the detection of a single marker, but allows the detection of a broad range of tumour molecular markers.

The AdnaTests can be applied in several distinct cancer diagnostic areas. The first is for disease prognosis where persistence and/or and increase in levels of CTCs indicate disease progression or poor outcome. Secondly, analysis of CTCs provides a measure of the patient’s response to treatment. Persistence or reappearance of CTCs may indicate the need for additional or alternative treatment.

In addition, the biomarkers expressed in CTCs may provide insight into which drug targets are present on distant metastases and, therefore, which therapies may be effective. The reappearance of CTCs months after therapy may provide an early indication that the patient has relapsed.

Finally, measurements of biomarker expression(s) in Adna-tests have the potential to significantly improve the drug development process and commercialization of drug candidates by yielding safer drugs with enhanced therapeutic efficacy in a faster and more cost-effective manner.

Dr. Berwyn Clarke, Chief Scientific Officer, Lab21 Ltd commented: “This agreement underscores our determination to exploit new and emerging technologies in molecular diagnostics. Detecting circulating tumour cells provides physicians a means to monitor therapy. Since cancer is evolving from a fatal condition towards a chronic disorder, Lab21 Ltd wants to position itself to offer tools for improved patient management as well as cost control. We also see this as a key new service to offer our pharmaceutical partners as they develop new anti-cancer agents.”

Lab21 expects to be ready to launch the new service from its clinical diagnostic service centre in Cambridge in October 2009.

Alex Weis, Chief Executive Officer of AdnaGen remarked: “We are very pleased that Lab21 Ltd will be AdnaGen’s exclusive partner in distributing our proprietary tumour diagnostics in the United Kingdom and Ireland. This is an important milestone in our efforts to achieve significant revenue traction with the objective of Company profitability in 2010. Lab21 Ltd has proven its competence in bringing novel diagnostics successfully into the in-vitro diagnostics market. We are confident that the partnership with Lab21 Ltd will further expand our effort to commercialize molecular tests for variety of cancers that allow physicians and patients to individualize treatment decisions.”

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