27.05.09
Lab21 expands oncology portfolio with 5-FU personalised chemotherapy management service

Cambridge, UK – 27th May 2009 - Lab21, the healthcare diagnostics company, is pleased to announce that it has expanded its range of oncology products and services through an agreement with US-based Saladax Biomedical, Inc. to launch a novel Personalised Chemotherapy Management (PCM®) service called DoseCheck™ in the UK, Ireland and Middle East.
The Saladax system was developed for the clinical management of cancer patients being treated with 5-fluorouracil (5-FU), which is one of the most widely used chemotherapy agents for colorectal, pancreatic and other cancers. More than 16,000 patients a year in the UK alone receive 5-FU as first-line therapy for metastatic colorectal cancer.
Until now, one of the key issues for the use of this anti-cancer treatment is variability in the way that individual patients metabolise the drug and this can only be managed by careful measurement of drug levels in the blood. If the drug is at too high a level it causes significant side-effects and conversely at too low a level it is clinically ineffective. Recent clinical studies in colorectal cancer demonstrate that carefully monitoring the level of drug in individual patients can result in dramatically increased efficacy of treatment, prolonged symptom-free survival and a reduction in serious side-effects.
For the first time, patients on 5-FU in the UK now have access to this major advance in cancer management through the use of the simple  DoseCheck™ blood monitoring technology available through Lab21.  
Berwyn Clarke, Chief Scientific and Development Officer of Lab21, said: “We are delighted to bring this important development in the treatment of cancer to oncologists in Europe,  allowing them to regularly and routinely monitor blood levels of 5-FU to ensure that patients are receiving the  optimal dose of drug. This service will benefit patients by providing a better quality of life during treatment and offering the potential of longer survival. We are also very pleased to establish this first business relationship with Saladax Biomedical, which has a series of additional PCM products that we hope to add to our growing portfolio of oncology products and services.”
Dr Sal Salamone, CEO of Saladax Biomedical, commented: “We are very pleased to be expanding the availability of our 5-FU PCM Assay to the markets served by Lab21.  Our objective is to make this unique new tool available to oncologists around the world for the improvement of cancer patient care.”
Under the Lab21 service, a small blood sample will be taken from patients during chemotherapy treatment and the plasma will be sent to Lab21’s reference laboratory in Cambridge for 5-FU analysis using the PCM assay. The results, which are returned to the clinician within about 7 days, are determined using a simple assay which already has European regulatory approval.  The 5-FU level calculated then determines the dosage adjustment to be made at the patient’s next treatment.
Lab21 intends to launch the DoseCheck™ service initially in the UK followed by Ireland and countries in the Middle East. For enquiries please call on +44 (0)1223 395454 or visit www.lab21.com/dosecheck.php

For further information:
Lab21:
Graham Mullis, CEO
Maddy Kennedy, CFO
Dr Berwyn Clarke, CSDO
t: +44 (0)1223 395461
e: graham.mullis@lab21.com
maddy.kennedy@lab21.com
berwyn.clarke@lab21.com

For media and investor enquiries:
Buchanan Communications
Mark Court / Rebecca Skye Dietrich / Katharine Sutton
t: +44 (0) 20 7466 5000
e: markc@buchanan.uk.com
rebeccad@buchanan.uk.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 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 and Ipswich. It also has R&D operations in Cape Town, South Africa. The Company's investors include Merlin Biosciences, Nexus Medical Partners, Medicis Ventures, Rowan Dartington and Kreos Capital.
Website: www.lab21.com

 

About Saladax Biomedical, Inc.
Saladax Biomedical, Inc. is a personalised medicine diagnostics company with its main R&D and manufacturing facilities based in Bethlehem, PA. Founded in 2004, Saladax is pioneering the development of a line of proprietary Personalized Chemotherapy Management (PCM®) assays to test plasma levels of the most commonly used anti-cancer medicines.
For more information about Saladax, visit www.saladax.com.