A Medical Device Daily

DxS Ltd. (Manchester, UK), a personalized medicine company focused on the development of companion diagnostics, has reported an agreement with AltheaDx (San Diego), which will provide U.S. study centers with access to K-RAS mutation detection assays from DxS.

The deal will see AltheaDx, an oncology diagnostic and biopharmaceutical services company, use the British firm's K-RAS mutation test kit to support clinical research where cancer patients are assessed for their K-RAS mutation status.

The DxS K-RAS mutation test kit allows clinicians to screen patients for mutations in the K-RAS gene, which is mutated in roughly 35% to 45% of metastatic colorectal cancer, as well as a variety of other cancers. Patients carrying mutations in the K-RAS gene do not respond to a class of drugs known as EGFR inhibitors – such as Vectibix and Erbitux.

DxS said the agreement builds on its continued expansion, including an exclusive global distribution agreement with Roche (Basel, Switzerland) earlier this year.

For the U.S. company, the agreement also builds on its biomarker development collaboration with BiPar Sciences and Poniard Pharmaceuticals.

AltheaDx said the accord "reinforces the position of AltheaDx as the premier biopharma partner for signature discovery and companion diagnostic development."

Dr. Stephen Little, CEO of DxS, said, "[This] deal with AltheaDx, a leading provider of biopharma testing services and cancer diagnostics, confirms once again that the K-RAS test is now the gold standard' assay of choice for detecting mutations in K-RAS."

He added, "We look forward to working with AltheaDx and expanding our reach in the U.S. clinical trial market."

AltheaDx CEO David Macdonald said, "Our agreement with DxS expands our capability to market-leading technology in genetic cancer testing. The DxS kit will enable [us] to offer K-RAS analysis for future clinical trials, in order to further advance the developments that have seen patients being prescribed the appropriate targeted [therapeutic] based on their genetic profile."

DxS has a range of products, including cancer mutation assays and kits, molecular diagnostic technologies and genetic analysis services. Its TheraScreen line of CE-marked kits can identify genetic tumor mutations affecting how patients respond to cancer therapies, enabling doctors and drug companies to provide the treatment most likely to benefit patients.

Patients to get more say in NHS services

The UK Department of Health has urged Primary Care Trusts (PCTs) to engage better with patients and the public in developing plans and making decisions about local health services.

New guidance, published last week, will help the public have more say in decisions made by their PCT, enabling them to shape local health services. The Department of Health said the strengthened "Duty to Involve" guidance also will make feedback on public consultations more transparent and accessible.

The "Real Involvement" guidance was being issued, the department said, to help PCTs and other National Health Service (NHS) organizations understand changes, and also to offer practical advice on how to put local people at the heart of service changes.

"Increased patient involvement will enable local NHS organizations to put patients' wishes first and give staff the freedom to respond and deliver safer, more personalized care, the Department of Health said. "Developing NHS services in partnership with the public and staff plays an important role in creating a modern NHS which meets the changing needs of the population both nationally and locally."

In making the announcement, Health Minister Ann Keen said, "Feedback from patients is one of the most powerful tools available to the NHS to help improve services which is why the Duty to Involve' has been strengthened. The NHS is a public service, so it is only right that the public should have their say on how the service is shaped."

The new Duty to Involve also is expected to be included in the NHS Constitution, which is due to come into force next year.