04.08.09
Lab21 Ltd to Provide AdnaGen’s CE-Marked System for the Detection and Analysis of Circulating Tumor Cells (CTCs) in the United Kingdom and Ireland.

Cambridge, United Kingdom, Langenhagen, Germany, and San Antonio, Texas – August 4, 2009 – Lab21 Ltd and AdnaGen AG announced today that they have entered into an exclusive service and distribution agreement for AdnaGen’s proprietary CE-certified circulating tumor cell diagnostic assays in the United Kingdom and Ireland. These tests are based on the capture of circulating tumor cells (CTCs) from blood and subsequent detection of tumor-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 aimed at improved disease prognosis and patient management. The tests rely on immunomagnetic selection of tumor cells from blood followed by detection of tumor-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 tumor molecular markers.

The AdnaTests can be applied in several distinct cancer diagnostic areas. The first is for disease prognosis where persistence and/or 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 tumor 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 tumor diagnostics in the United Kingdom and Ireland. This is an important milestone in achievement of significant revenue traction and will lead the Company to 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.”

About AdnaGen

AdnaGen was founded in 1999 as a privately held biotechnology research and development company based in Langenhagen, Germany. He majority of AdnaGen was recently acquired by OncoVista Inc. and is now a part of an integrated healthcare organization. AdnaGen offers test systems enabling physicians an individualized treatment of cancer. AdnaGen´s core expertise is the development of innovative tumor diagnostics by utilizing its proprietary technology for the detection and molecular analysis of circulating tumor cells (CTC). Kits for breast (AdnaTest BreastCancer), colon (AdnaTest ColonCancer) and prostate cancer (AdnaTest ProstateCancer) as well as an add-on kit for the detection of steroid receptors (AdnaTest ER/PR) on CTC are CE-marked and currently marketed in Europe. A kit for the detection of CTC in ovarian cancer will be available soon. Further developments comprise several molecular markers that reveal the presence of potential therapeutic targets on CTC. The analysis of expression profiles of these markers is also contributing to a better understanding of the biology of CTC. Meanwhile, AdnaGen has developed 11 add-on assays (patent pending) that can be used in combination with all commercialized AdnaTests to address these issues. Clinical results are available that underline the clinical importance of these markers.
AdnaGen is ISO 9001 and EN 13485 certified. For more information, go to www.adnagen.com

About Lab21

Lab21 is a global provider of state-of-the-art diagnostic products and services, supporting blood bank screening, medical diagnostics and drug discovery. Its customers include international healthcare providers, pharmaceutical and biotechnology companies.
The product division of the Company manufactures immunodiagnostic kits and reagents that are distributed into 110 international countries and is focused on infectious diseases for the blood-banking market.
The service division has a growing test portfolio providing companion diagnostics and high technology molecular assays for the growing integration of personalised medicine into healthcare. These services are currently in infectious diseases, oncology and pharmacogenetics areas with emerging interests in cardiovascular and metabolic disease.
Lab21's clinical reference laboratory and corporate office is based in Cambridge and has additional UK manufacturing sites in Newmarket, Bridport and Ipswich. It also has R&D operations in Cape Town, South Africa. The Company's investors include Merlin Biosciences, Nexus Medical Partners, Medicis Capital, Rowan Dartington and Kreos Capital.
Website:  www.lab21.com

About OncoVista, Inc.

OncoVista is a biopharmaceutical company engaged in the development and commercialization of targeted cancer therapies which are more efficacious and less toxic. Further information on OncoVista can be found at www.oncovista.com

For further information, please contact:

Lab21 Ltd
Dr. Berwyn Clarke
Tel: + 44 1223 395461
E-Mail: Berwyn.Clarke@lab21.com
Web: www.lab21.com

AdnaGen, AG
Dr. Alexander Weis
Tel: + 49 (0)511 72595050
E-Mail: a.weis@oncovista.com
Web: www.adnagen.com

OncoVista, Inc.
Dr. Alexander Weis
Tel: + 1 210.677.6000
E-Mail: a.weis@oncovista.com
Web: www.oncovista.com

Forward-Looking Statements: A number of statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the applicable statements. These risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the applicable statements.