24.09.08
Lab21 expands its range of cardiovascular genetic tests with Clinical Data, Inc.

Lab21 Corporate News Item 43

Cambridge, 24 Sept 2008 … Lab21 announced today the expansion of its portfolio of genetic tests for inherited cardiac syndromes, enabling Lab21 to offer its customers one of the most extensive suites of genetic cardiac tests in Europe.

Through its existing UK licence with PGxHealth™, a division of Clinical Data, Inc. (NASDQ: CLDA), Lab21 offers exclusive U.K. and Ireland access to the Familion® portfolio of tests for Long QT and Brugada Syndromes and has now added two new assays for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) and Hypertrophic Cardiomyopathy (HCM) to its range of tests.

CPVT is potentially the most lethal of the inherited cardiac channelopathies being particularly difficult to diagnose in the absence of genetic testing. HCM is the most common form of heart muscle disease, affecting 1 in 500 individuals and is the most common cause of sudden cardiac death in people below the age of 30.

Berwyn Clarke, Lab21 Chief Scientific and Development Officer commented: “We are delighted to expand our relationship with PGxHealth, who we believe is the market leader in the development of advanced genetic tests for inherited cardiac conditions. The addition of CPVT and HCM to the Familion stable substantially assists UK cardiologists in the accurate diagnosis of cardiac disease. By enabling cardiologists to quickly identify a patient’s risk, the most appropriate monitoring, treatment or lifestyle options can be implemented, significantly improving patient health.”

Lab21 Commercial Manager, Richard Hughes, added: “The addition of these two new tests provides one of the most comprehensive panels of validated cardiovascular genetic tests available in Europe. As the Familion LQTS tests have become more widely adopted, many of our customers have requested the introduction of tests for CPVT and HCM and we are delighted that through PGxHealth we are now able to offer this.”

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About CPVT
Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) is an inherited heart rhythm disorder caused by mutations in critical proteins that comprise the calcium release channel (ryanodine receptor) macromolecular complex in the heart. CPVT may cause exercise-induced ventricular arrhythmias and/or syncope occurring during physical activity or acute emotion, but demonstrates no structural problems in the heart. The majority of these events occur during childhood, adolescence, and young adulthood. More than 60% of affected individuals will have a first episode of syncope or cardiac arrest by age 20. About 50% of affected individuals harbour a mutation in the RYR2 gene which encodes the pore-forming subunit of the cardiac calcium release channel and forms the basis of the FAMILION CPVT test.

About Hypertrophic Cardiomyopathy(HCM)
HCM is characterized by thickening of the heart muscle (hypertrophy) in the absence of an apparent cause such as hypertension. Several other conditions also can result in similar unexplained thickening of the heart muscle, which further complicates diagnosis and management. With the FAMILION HCM test, providers can distinguish HCM from these other conditions, as well as gain a better understanding of the potential for a patient’s family members to fall victim to this disorder. While there is no cure, medical management including prescription medications, surgical procedures and/or an implantable cardioverter defibrillator can reduce risk of cardiac events. The FAMILION HCM test analyzes 9 genes associated with HCM, making it the most comprehensive genetic test available for HCM testing. The clinical presentation and progression of HCM can vary tremendously. Typically, symptoms begin during late childhood and adolescence, although they may not appear until well into adulthood. These symptoms are common to many other conditions and can include breathlessness, especially during exercise, syncope (fainting), heart palpitations and dizziness. An echocardiogram is commonly used to help establish or confirm the diagnosis, but relying solely on the echocardiogram could lead to misdiagnosis. The most reliable diagnosis is achieved with a combination of genetic testing, echocardiogram and electrocardiogram (ECG).

About FAMILION®
The FAMILION family of tests detects genetic mutations that can cause cardiac channelopathies or hypertrophic cardiomyopathy (HCM). Cardiac channelopathies are rare, potentially lethal heart conditions, including Long QT Syndrome (LQTS), Brugada Syndrome (BrS) and Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). By detecting genetic mutations, the FAMILION tests can be used to recognize inherited forms of cardiac channelopathies or HCM in individuals and their families, helping to guide treatment and reduce the deadly cardiac events they can cause.
For cardiac channelopathies that have already been diagnosed, the test can help doctors and patients make more informed treatment decisions and aid in uncovering other possibly asymptomatic family members who are at risk. For patients suspected of having HCM, the test can help doctors confirm the patient’s diagnosis and aid in uncovering asymptomatic family members who are HCM carriers.

About Lab21
Lab21 is a global provider of state-of-the-art diagnostic products and services, supporting drug discovery, healthcare and environmental monitoring. Its customers include healthcare providers, pharmaceutical and biotechnology companies, in addition to organisations that need to monitor their impact on the environment.

The Company has a growing test portfolio providing companion diagnostics and high technology assays for the growing integration of personalised medicine into healthcare. These services and products are currently in infectious diseases, oncology and pharmacogenetics areas with emerging interests in cardiovascular and metabolic disease.

Lab21's environmental monitoring business specialises in the detection of heavy metal contamination in soil and water. Its products provide information to help organisations take action to reduce pollution and to protect the water supply of millions of people globally.

Lab21's clinical reference laboratory and corporate office is based in Cambridge and employs 50 people. The Company's investors include Merlin Biosciences and Kreos Capital

Website: www.lab21.com

 

About PGxHealth
PGxHealth LLC., a division of Clinical Data Inc., has extensive experience and capabilities in the development, clinical validation and delivery of genomics-based tests, in particular of efficacy and safety biomarkers for appropriate drug utilization. Through its own know-how and resources, work conducted with some of the world’s most prestigious genomics thought leaders and institutions, and use of innovative technologies, PGxHealth is focused on reducing treatment costs and improving clinical outcomes in those disease states and therapeutic classes beset with expensive, inefficient or suboptimal treatment options. It has branded its genetic tests based on these proprietary genetic markers Therapeutic Diagnostics™. Visit the company’s website at www.pgxhealth.com.

Contacts at Lab21:

Media relations for Lab21:
Northbank Communications
Tony Stephenson, Account Manager
Sue Charles, CEO
Claire Mosley, Account Executive
t : +44 (0) 20 7268 3002
e: lab21@northbankcommunications.com

At Lab21:
Dr Berwyn Clarke, CSDO
Richard Hughes, Commercial Manager
t : +44 (0)1223 395450
e: richard.hughes@lab21.com or berwyn.clarke@lab21.com