As precision medicine expands into a growing number of therapeutic areas, yesterday’s “one size fits all” approach to drug development is becoming less common. Instead, targeted patient populations for new therapies are shrinking, a trend that’s expected to continue as pharmaceutical and biotech companies race to pursue—and eliminate—the largest opportunities first. In this rapidly evolving landscape, sponsors need to think carefully about how to commercialize each precision medicine therapy’s companion diagnostic (CDx) if they want to maximize their new treatment’s chances of success.
Historically speaking, pharmaceutical sponsors have tended to underinvest in CDx commercialization. This lack of investment has had a major negative impact on how quickly new precision medicine therapies could reach the right patients, delaying access to potentially lifesaving treatments and leading to financial repercussions for sponsors.
Research performed by Diaceutics, for instance, shows an average of 4.5 years will pass between the launch of a new test and its clinical uptake within the biomarker-positive patient population it was meant to identify. The result of this delay: As many as 50% of oncology patients do not have access to the testing they need to find the most appropriate biomarker-guided treatment for their disease. Closing this gap will require sponsors to develop robust CDx commercialization strategies—ones that give equal weight to development and commercialization. Even the world’s most innovative science is useless if it can’t reach real-world patients.
Start with the end in mind
It’s all too common for sponsors to evaluate prospective CDx partners on the basis of their development capabilities and scientific expertise. These are important qualities, to be sure, but it’s also critical to find a partner with deep and far-reaching commercialization experience and extensive market penetration for the technology and therapeutic area that your CDx assay will target.
“We’ve helped to develop dozens of companion diagnostic assays,” says Nigel Clarke, CSO and VP for research and development at Quest Diagnostics. “We’ve also supported multiple late-stage and post-approval projects through imminent go-to-market and commercialization challenges. Several clear patterns have emerged. The most important: when developing and launching a CDx, start with the end in mind when it comes to your assay development. First solve for commercialization—development will follow from there.”
Reimbursement policies often fail to account for the costs and effort associated with CDx development. They may also underestimate the value these diagnostics provide to patients and the downstream savings they’ll create within the health care system overall. As a result, operating companion diagnostic programs is often economically viable only for the lab that was paid to develop the assay. Thus development and commercialization activities are intrinsically intertwined.
“Whomever you select to develop your CDx needs to be the partner who helps you take it to market,” says Clarke. “This might seem obvious, but in fact, very few—if any—of the projects we’ve seen late in development or post-approval were intentionally brought to us as part of a planned strategy. If they had been, we would have seen them at least 12 to 18 months earlier.”
What to look for in a CDx commercialization partner
To maximize the chances of commercialization success, a CDx lab partner must go beyond demonstrating scientific expertise. They should have access to a robust market penetration infrastructure, the ability to navigate a complex regulatory environment and extensive experience gaining support from payers. They should also have well-established physician education programs to drive awareness and adoption of the new tests, and they should maintain integrated systems that ease ordering and sample collection.
“The right companion diagnostic partner is the one who takes the most comprehensive approach,” says Greg Baschkopf, executive director for companion diagnostics at Quest Diagnostics. “This covers all areas—from physician awareness to sample availability, collection and logistics, all the way through timely results delivery and robust reimbursement strategy. Putting all of these things together ensures that the right test will be delivered to the right patient at the right time. This is a foundational principle in precision medicine.”
Such a comprehensive, holistic approach encompasses an array of capabilities. These include a clear strategy for managing the logistics of sample collection and transportation, high-quality lab operations that maintain the integrity of each specimen and streamlined processes for faster test turnaround. A diagnostic testing partner that can consistently deliver results within the clinical decision window will have a significant positive impact on patient care, making it possible for new therapies to reach the populations that need them as quickly as possible.
Would you like to learn more about these capabilities and their importance in advancing access to precision medicine? Download CDx Market Access: The Path to Precision Medicine Success. In this new white paper from Quest Diagnostics, you’ll gain insights into how to evaluate potential CDx partners on the basis of proven ability to effectively commercialize assays.
