Novartis, QIAGEN Sign Deal To Develop Companion Diagnostics

By Jof Enriquez,
Follow me on Twitter @jofenriq

QIAGEN, a provider of sample and assay technologies, recently signed an agreement with Swiss pharmaceutical firm Novartis to develop and commercialize companion diagnostics for Novartis’ existing and future portfolio of drugs. Financial terms of the deal were not made available.

“We are very pleased to be working with Novartis in the development and commercialization of companion diagnostics to support their innovative pharmaceutical products. Healthcare providers are increasingly benefiting from personalized treatment strategies based on genomic insights, to select the right drug for the right patient at the right time and in the right dose,” Peer M. Schatz, CEO of Qiagen, said in a company statement. “This broad agreement gives Novartis and QIAGEN the flexibility to pursue co-development projects. We are committed working with our partners like Novartis to make improvements in life possible.”

In the statement, QIAGEN said that the Novartis deal was the ninth master framework agreement it had signed with a pharmaceutical firm or biotech company. QIAGEN is looking to close at least 20 more deals of similar nature with industry partners. The company said that the deals will add to its already sizable portfolio of companion diagnostics based on molecular biomarkers for cancer treatments.

More companies are collaborating to tap into the burgeoning companion diagnostics market, which is estimated to hit $5.6 billion in 2019, according to a Transparency Market Research report.

Late last year, Siemens entered into a master collaboration agreement with Pfizer to develop in vitro diagnostic tests for use in clinical studies and commercialization with Pfizer products. In March this year, Ventana Medical Systems, a member of the Roche Group, inked a multi-year deal with Bayer to develop companion diagnostics, with a focus on immunohistochemistry (IHC), across Bayer’s portfolio of targeted therapies. Ventana followed that up with a partnership with Merck in July.

“In the past, medical devices have been separated from drugs and biologics, and companion diagnostics are one way where we're breaking down those barriers,” Michael Drues, Ph.D., president, Vascular Sciences, recently wrote in a Med Device Online (MDO) column. “Medical device manufacturers should wake up to the tremendous opportunity to bring new companion diagnostics onto the market.”

The FDA announced in August that it is going to begin regulating medical laboratory testing, including companion diagnostics and laboratory developed tests, according to a previous MDO article. The agency subsequently issued draft guidance documents for In Vitro Companion Diagnostic Devices and Laboratory Developed Tests (Framework for Regulatory Oversight of Laboratory Developed Tests and Notification and Medical Device Reporting for Laboratory Developed Tests).