While molecular diagnostics may never completely replace “turn and cough,” it continues to gain prominence—from the companion diagnostics used to separate out potential responders to a specialty drug, to establishing a faster, more sensitive test for something as prevalent as tuberculosis. Opportunities for all stakeholders abound in developed and developing countries alike, as do the pitfalls associated with trying to take advantage of them. New markets emerge, regulations evolve, and technologies try to keep pace—sometimes by becoming less intense.
CHI’s “Molecular Med Tri-Con 2012” conference will provide the opportunity for players to discuss the issues and garner insights from one another.
Many drugs are coming through the pipeline paired with biomarkers. As these come to fruition over the next few years, drug companies need ways of testing for these markers—whether it’s by organically growing or acquiring a diagnostics arm, or by forming collaborations or partnerships with a diagnostics firm interested in creating a companion diagnostic.
“People need these drugs, and pharma is not going to walk away from millions or billions of dollars in investments because they can’t figure out an assay,” says Mya Thomae, CEO of Myraqa, a California-based consultancy.
While diagnostics companies may have great technology, they may not have ever had to go through an FDA clearance or approval. Companion diagnostics tends to be held to a higher level of regulatory scrutiny than other types of assays.
They need to be able to put their best foot forward to show that they’re up to the task—“they have a plan for quality systems, they’re putting in the right infrastructure to support a regulated product,” Thomae points out. “So they can show a pharma company when they come in to do their due diligence on the partnership that they’re ready to go.”
Part of this is realizing that the drug company will be aiming for a particular FDA approval date, and that the diagnostic company has to be prepared to file its application alongside the drug’s application and be ready when the drug is ready for approval. They need to be “working in lock-step, to make sure the assay is correct, it’s ready in time for clinical trials, and the other regulatory work they need to do is ready to go,” she warns. Otherwise, they could delay the drug getting to market.
Companies also need to realize that while it’s in pharma’s interest to have tests as widely available and inexpensive as possible—especially if they’re required for treatment to be prescribed—that is generally not the case for the diagnostics companies.
A drug company may help support development and clinical testing, but it will be up to the diagnostics company to make sure they’re doing things efficiently from a cost-of-goods perspective so that the test is profitable, explains Thomae. “This is a fundamental challenge, and one of the reasons that companion diagnostics have taken a while to make it to market.”