Siemens Healthcare Diagnostics has partnered with two pharmaceutical companies, ViiV Healthcare and Tocagen, to develop diagnostic tests alongside targeted drugs for HIV and cerebral cancer.

As ViiV Healthcare is a joint venture of Pfizer and GSK focused on HIV treatment, the partnership represents a collaboration of leading pharma and medtech companies.

It also signals major company investment in ‘stratified medicine’, where drugs targeting narrow patient groups are developed alongside ‘companion diagnostics’ to identify suitable patients.

Siemens CEO Michael Reitermann said the new projects would “align Siemens with new classes of therapies tailored to the individual”.

ViiV Healthcare will partner with Siemens for clinical trials of its first-in-class CCR5 co-receptor antagonist Celsentri (maraviroc) and investigate the commercial prospects of a diagnostic test to assist in patient selection.

Celsentri was licensed in 2007 in Europe and the US as a treatment for CCR5-tropic HIV. It is currently in a phase III study to establish its efficacy in combination with darunavir/ritonavir.

The planned trials will put the combination head-to-head with the combination of Gilead’s Truvada and darunavir/ritonavir.

US company Tocagen will partner with Siemens to produce diagnostic tests to support clinical trials of Tocagen’s viral gene therapy Toca in two forms, injectable Toca 511 and extended-release Toca FC tablets, in treating primary brain cancer.

For diagnostics companies such as Siemens, gaining access to the companion diagnostics market – which is already worth $1.5bn – depends on collaboration with pharma companies.

Bristol-Myers Squibb (BMS) has entered into a broad framework agreement with Dako on the development of pharmacodiagnostic tests.

The agreement, which builds on a collaboration begun in 2008, aims to develop diagnostics to identify patients more likely to benefit from treatment with BMS investigational drug candidates.

Pharmacodiagnostics (or companion diagnostics) are an important feature of the growing personalised medicine approach, which can improve outcomes and reduce healthcare costs by identifying individuals who are more likely to benefit from specific therapies.

Dako, a global leader in tissue-based diagnostics, has a history of developing clinical diagnostics in collaboration with pharmaceutical companies that are used in conjunction with drugs.

“It is a great pleasure for me to announce Dako’s new collaboration with Bristol-Myers Squibb,” said Lars Holmkvist, CEO of Dako. “This alliance heralds the intentions of both companies to work closely together to develop new diagnostic tests linked to drugs for the higher purpose of identifying the patients most likely to respond to treatment.”

“It is part of Dako’s long-term strategy to collaborate with pharma companies on the development of companion diagnostic tests.”

Based in Denmark, Dako produces reagents, instruments and software used by hospitals and clinics in more than 80 countries worldwide in the diagnosis of cancer and the planning of its treatment.

Life Technologies is to join GlaxoSmithKline (GSK) Biologicals in developing a diagnostic to be used with a GSK cancer immunotherapy.

Life will develop a multi-gene qPCR-based molecular in vitro diagnostic assay for GSK’s MAGE-A3 cancer immunotherapy candidate designed to identify patients likely to benefit from the treatment.

Kim Caple, Head of Molecular Diagnostics at Life Technologies, said: “Life Technologies' platform technologies, such as qPCR, are allowing biological knowledge to be applied in multiple markets, including companion diagnostics.”

MAGE-A3 is currently being evaluated in two clinical trials, MAGRIT and DERMA, evaluating safety for patients with non-small cell lung cancer whose melanoma has invaded lymph nodes.

Under the terms of the agreement, Life Technologies and GSK will develop and commercialise the qPCR-based test to detect MAGE-A3 positive patients most likely to benefit from MAGE-A3 ASCI. 

Based in California, Life Technologies is a global biotechnology company that manufactures both molecular diagnostic and research use only products.