RESEARCH TRIANGLE PARK, N.C., SAN DIEGO and TARRYTOWN, N.Y., Feb. 7, 2012 /PRNewswire/ -- Siemens Healthcare Diagnostics announces two new companion diagnostics partnerships with pharmaceutical companies ViiV Healthcare and Tocagen — marking a major step for Siemens (NYSE: SI) into this important and fast-growing segment of the in vitro diagnostics (IVD) market. Both partnerships intend to leverage the clinical trial and commercialization options within Siemens' CLIA laboratory, as well as Siemens' established IVD clinical and regulatory expertise.
Siemens' partnership with ViiV Healthcare will focus on clinical trials related to Celsentri/Selzentry® (maraviroc) — ViiV Healthcare's novel CCR5 co-receptor antagonist for the treatment of CCR5-tropic HIV — followed by potential commercialization of a diagnostics test to assist in patient selection prior to physician treatment decisions, subject to FDA approval. According to the World Health Organization, 33.3 million people worldwide were living with HIV as of 2009. That same year, 2.6 million new infections were reported and 1.8 million people worldwide died of AIDS-related illnesses.
The Siemens - Tocagen relationship will begin with diagnostic tests to support clinical trials related to Tocagen's unique viral gene therapy (Toca 511 & Toca FC) under investigation for the treatment of primary brain cancer, followed by potential commercialization of diagnostic tests for therapy monitoring, subject to FDA approval. According to the American Cancer Society, primary brain and central nervous system cancers are expected to account for 22,910 new cases and 13,700 deaths in 2012. Additionally, the National Institutes of Health estimates that 10-30% of all adults with cancer will develop brain metastases.Widely considered a major step towards the vision of personalized healthcare, companion diagnostics are clinical tests linked to a specific drug or therapy intended to assist physicians in making treatment decisions for their patients. The technology and science behind the field allows pharmaceutical drug developers to identify subpopulations of patients more or less likely to respond favorably to a particular drug or therapy, and those more or less likely to experience unfavorable side effects.(1) The companion diagnostics market, worth an estimated $1.5 billion annually, is reportedly the fastest growing segment in the IVD industry, due largely to demand for safer, higher quality drugs.(2) Complementing a move into next-generation sequencing, Siemens' companion diagnostics business will establish relationships with pharmaceutical companies to offer clinical trial expertise as well as diagnostic test development and commercialization. The company's CLIA-certified clinical lab in Berkeley, California is capable of offering a broad range of nucleic acids and immunoassay tests, as well as developing new test approaches as required. "Siemens' presence in the emerging companion diagnostics market enables us to leverage our innovation capabilities and deep clinical knowledge to help improve pharmaceutical drug safety and effectiveness," said Michael Reitermann, CEO, Siemens Healthcare Diagnostics. "More so, it helps align Siemens with new classes of therapies tailored to the individual that hold the promise of improving patient care and delivering on the goal of personalized medicine." ViiV Healthcare previously announced the start of the Phase III MODERN Study [Maraviroc Once daily with Darunavir Enhanced by Ritonavir in a Novel regimen], also known as A4001095, comparing its CCR5-inhibitor, Celsentri/Selzentry® (maraviroc), to emtricitabine/tenofovir (Truvada®), both in combination with darunavir/ritonavir. The 96-week trial will evaluate a two-drug versus three-drug once-daily regimen for the treatment of antiretroviral-naive patients infected with CCR5-tropic HIV-1.
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