A sign of the business logic behind creating diagnostic tests that complement drugs in development is the manufacturing expansion under way at Qiagen. The biotech's campus is being readied to boost capacity for its molecular test business. Hiring will accompany the expansion.
Qiagen, an established diagnostics developer, partners with traditional drugmakers during early development, creating the opportunity for simultaneous drug and diagnostic regulatory approval. And the FDA has shown support, last week approving a drug and its companion diagnostic for late-stage melanoma, opening the door for manufacturing and commercialization. That approval came months ahead of schedule, according to the Washington Post.
A certain matchmaking is required between diagnostics and drug developer, says Jeff Cossman, CEO at United States Diagnostic Standards, in the story. Qiagen recently teamed with Pfizer ($PFE) to develop the companion diagnostic for use with the Big Pharma's anti-cancer drug, dacomitinib. The deal includes collaboration during clinical trials, as well as submissions for premarket and regulatory approvals, says Proactiveinvestors.
The elements needed to produce diagnostic tests for a condition's presence in an individual are usually either at hand or accessible during early drug development. No use letting that discovery and development data go to waste. The combo may be a step shy of personalized medicine, but it's certainly a step in that direction.
Financially, it's a good-news/bad-news story for pharma manufacturing. The good news is drugs better matched to patients, yielding better outcomes. The bad news is the narrowing of the market of med-takers, yielding shorter drug runs and revenues. But there is some middle ground in potential FDA approvals for drugs in restricted populations; those drugs might otherwise go unapproved.