A Medical Device Daily

DxS (Manchester, U.K.) reported that it has signed a non-exclusive global licensing agreement with the Wellcome Trust (London) to provide a research test for use in clinical trials to detect the presence of the V600E B-RAF mutation, which is found in melanomas, lung and thyroid cancers.

The V600E B-RAF mutation was identified by scientists at the Wellcome Trust and can be found in 36% to 40% of skin and thyroid cancers and up to 13% of cancers in the large intestine.

Researchers will use the test to determine a patient's cancer mutation status, which may predict how they respond to cancer therapies. If clinical trials are successful, this could lead to companion diagnostics to predict response for novel cancer therapies for skin, thyroid and large intestine cancers.

Stephen Little, CEO of DxS, said: "With many novel drugs in development for skin, thyroid and colon cancer the potential for this assay is enormous. Through this licensing agreement, we plan to expand the range of biomarker tests to our customers, aiding the treatment of a number of types of cancer."

Glenn Wells, business development manager at Wellcome added: "We believe the identification of the B-RAF mutation could have considerable implications for the way in which treatment of melanomas, lung and thyroid cancers are handled, and are extremely pleased to have reached this agreement with DxS to allow further research and clinical trials to be undertaken with this assay."

Using their real-time PCR technology Scorpions, DxS has developed a highly sensitive and selective test able to detect mutations at very low levels, and can be performed in less than three hours.

Financial details were not disclosed.

In other agreements and contracts news, Novation (Irving, Texas), a healthcare contracting services company of VHA (Irving, Texas), University HealthSystem Consortium (Oak Brook, Illinois) and Provista (Irving, Texas), said it has added Guidant's (Indianapolis) Cardiac Rhythm Management devices to its Boston Scientific (Natick Massachusetts) agreement.

The Cognis CRT-D and the Teligen ICD are among the world's smallest and thinnest high-energy devices at 32.5 cc and 31.5 cc respectively, while less than 10 mm thick. Both devices offer features based on substantial engineering advances, including extended battery longevity over previous company devices, self-correcting software and improved programming technology. The contract addition was effective Aug. 1, 2008.