Abstract
To combat the difficulties of getting a new CDx online with a reference lab and ready to go as soon as the drug and diagnostic receive regulatory approval, Qiagen has launched what it calls its Day-One program. Under this initiative, the company partners with diagnostics labs ahead of regulatory approval, providing the lab with investigational use only versions of the diagnostic.
Qiagen announced one such partnership in late November, with cancer genetics testing company NeoGenomics. “Together with our Pharma partners, we are now planning to provide investigational use only (IUO) tests to NeoGenomics, enabling them to verify and set up and run our companion diagnostics in clinical trials and in anticipation of regulatory approval,” said Qiagen CEO Peer Schatz in announcing the deal. “The companion diagnostic services can be provided by NeoGenomics once FDA approval has been obtained, facilitating the rapid adoption of innovative targeted therapies.”
Jonathan Arnold, Qiagen
The arrangement breaks the mold of waiting until a CDx has been approved to begin to arrange its placement with reference labs. But the idea, as the program name suggests, is to create a framework with alignment between the pharmaceutical company, Qiagen, and testing labs to accelerate commercial deployment of the CDx and the approved drug—what Schatz calls “synchronized launches of new oncology drugs.”
While a program like Day-One makes sense for Qiagen’s pharma partners, getting the diagnostic provider to hop on board before the CDx is approved can takes convincing, said Jonathan Arnold, head of next-generation diagnostics marketing at Qiagen.
“When they make the decision to begin investing in a test, they need to make a return,” noted Arnold. “So that is one of the barriers we’ve had to overcome rolling out this model. We ask them to take the risk with us and we will share some of the risk.”
What time is best to start the process? “When we approach [a testing company], we are highly confident the test is coming—we can’t guarantee it—but we believe it is coming,” Arnold said.
A more standard approach to working with labs to take on a newly approved CDx can delay running of the first test by as much as nine months, Arnold said, while the testing lab gears up, invests in equipment, and validates the test in its own environment. This lag in test availability “hurts the patients, hurts the pharma partner, hurts Qiagen, and hurts the lab because there is a window where that test isn’t available in the market,” he concluded.