New companions for new tests

Siemens heralds growth in CDx market with pair of partnerships

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TARRYTOWN, N.Y.—As it continues to strengthen its footholdin the diagnostics field, Siemens Healthcare Diagnostics has established twonew companion diagnostics partnerships, one with ViiV Healthcare and one withTocagen. The two partnerships will target the development of diagnostic testsfor HIV and brain cancer respectively, and provide Siemens with a strong boostin the companion diagnostics market.
"Siemens' presence in the emerging companion diagnosticsmarket enables us to leverage our innovation capabilities and deep clinicalknowledge to help improve pharmaceutical drug safety and effectiveness,"Michael Reitermann, CEO of Siemens Healthcare Diagnostics, said in a pressrelease. "More so, it helps align Siemens with new classes of therapiestailored to the individual that hold the promise of improving patient care anddelivering on the goal of personalized medicine."
The partnership with ViiV Healthcare will be centered onclinical trials related to Celsentri/Selzentry (maraviroc), ViiV's novel CCR5co-receptor antagonist for the treatment of CCR5-tropic HIV. ViiV's Phase IIIMODERN study will compare Celsentri/Selzentry with Truvada, both in combinationwith darunavir/ritonavir. The trial will compare the performance of a genotypictest with that of a phenotypic test in identifying patients that would benefitfrom use of Celsentri/Selzentry, and subject to U.S. Food and DrugAdministration (FDA) approval, Siemens might commercialize their genotypictropism diagnostic test.
"Our partnership with Siemens Healthcare Diagnostics is avaluable part of our commitment to addressing patient needs through developinginnovative treatment approaches," Dr. John Pottage, chief scientific andmedical officer at ViiV, said in a press release. "Celsentri/Selzentry is animportant treatment option for people living with CCR5-tropic HIV and wecontinue to support the evolution of tropism testing to provide physicians withaccurate, accessible and affordable companion diagnostics."
Siemens' partnership with Tocagen will focus on diagnostictests to support clinical trials related to Tocagen's viral gene therapy, Toca511 and Toca FC, which are under investigation for the treatment of primarybrain cancer. The studies consist of patients with high-grade glioma, such asglioblastoma multiforme. The companies will work together on the assays used inthe studies, and pending FDA approval, Siemens may commercialize diagnostictests that can monitor patient levels of Toca 511 and Toca FC.
"We believe that developing the necessary diagnostic testswith the right diagnostic partner is an important component for the successfulcommercialization of Toca 511 and Toca FC," Harry E. Gruber, CEO of Tocagen,said in a statement. "Siemens' capabilities in developing commercial viralassays in addition to their market presence in the diagnostics space make theman excellent complement to Tocagen's focus on the development andcommercialization of viral gene transfer products to treat advanced cancer."
Trevor Hawkins, CEO of Next Generation Diagnostics atSiemens Healthcare, says the new partnerships fall in line with the company'snew initiative, Siemens Agenda 2013, a two-year global initiative. He notesthat ViiV and Tocagen are very different in size, which is a bonus for Siemensas it highlights their ability to work with "a broad spectrum of partners."
"Siemens is in a rather unique position here," he adds. "Wedo not have a pharma division, and so we are able to have the luxury of workingboth with the established players and the up-and-coming future leaders in thismarketplace, such as the Tocagen relationship that we've now established."
Hawkins says he expects companion diagnostics to only becomemore prevalent as the pharmaceutical industry moves forward, citing "a growinglinkage between therapies and required companion diagnostic assays." Whilecompanion diagnostics have been particularly common in oncology, as a way todetermine patients' responsiveness to therapies, they are gaining popularityfor that purpose in other therapeutic fields as well, for patientstratification and to help determine dosing levels. The industry, he says, "ismoving towards a model where therapies will need to be tailored more and moreto the individual."
"When we think about companion diagnostics, people oftenthink that these are molecular tests, and in many respects they are, butthere's also immunoassay tests, there's also imaging that is used as part ofcompanion diagnostics," says Hawkins. "What is exciting from Siemens'perspective is that we have leadership positions in imaging, in diagnostics, inmolecular—and we have enabled ourselves to bring together these pieces of thejigsaw puzzle to solve what is quite a complex problem, in terms of being ableto give physicians the most up-to-date information on how to make decisionsabout how they treat their patients.
"We do foresee this area growing, and growing rapidly, andwe wholly anticipate future partnership with large and merging pharma partnersgoing forward," he adds.

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