- LabCorp has signed on to Qiagen's lab readiness program aimed at speeding patient access to Qiagen's companion diagnostics once the tests and their associated drugs win FDA approval.
- The goal is to allow molecular diagnostic labs to prepare early for the commercial launch of new cancer drugs and in vitro diagnostics being developed by Qiagen and its partners.
- Prelaunch preparations include readying for workflow implementation, training, assay verification, forecasting, medical communication and reimbursement, Qiagen said.
The deal comes as the Trump administration is ramping up efforts to speed coverage of newly approved IVDs and medical devices. Under President Donald Trump's fiscal year 2020 budget proposal, Medicare would cover devices approved through the FDA's Breakthrough Device Program for four years when used by seniors in clinical trials.
AdvaMed, which has pushed for reimbursement of breakthrough devices, argues doing so will not only boost patient access but incentivize companies to develop products for life-threatening or debilitating conditions.
The FDA is also exploring ways for private insurers and manufacturers to share information during presubmission meetings. Last year, UnitedHealth Group and CareFirst joined an ongoing pilot intended to shorten the delay between FDA approval of new devices and private payer coverage.
The LabCorp-Qiagen deal builds on an earlier collaboration between companies to ensure patient access to several precision IVDs, including assays for oncology and next-generation sequencing tools.
LabCorp's pipeline includes new companion diagnostics for a variety of cancers, including lung, breast, colorectal and bladder cancers. Farther out are companion IVDs for pan-tumor disease areas, the companies said.
Qiagen, a Netherlands-based holding company that sells assay technologies for molecular diagnostics, applied testing, pharmaceutical and academic research, had net sales of $1.5 billion in 2018. Roughly half of that stemmed from its molecular diagnostics business.
LabCorp reported net revenues of $11.3 billion last year, up from $10.3 billion in 2017. Of that 62% was tied to its diagnostics segment and 38% to drug development.
The lab giant saw its diagnostics operating income drop 22% in the 2018 fourth quarter due to reimbursement changes and factors. In particular, the company blamed the Protecting Access to Medicare Act for knocking $18 million of its operating income and contributing to lower diagnostic unit sales.