- LabCorp said Qiagen's new companion diagnostic for bladder cancer, the therascreen fibroblast growth factor receptor (FGFR) mutation analysis, is now being sold at the lab giant's specialty cancer labs.
- The test is designed to assess whether patients with urothelial cancer are eligible for treatment with Johnson & Johnson's newly approved FGFR kinase inhibitor Balversa (erdafitinib).
- Balversa, the first FGFR inhibitor to reach the U.S. market, is a biomarker-based targeted therapy approved to treat locally advanced or metastatic urothelial carcinoma with FGFR3 or FGFR2 genetic alterations. It is intended for patients who have progressed despite at least one line of prior platinum-containing chemotherapy.
The therascreen FGFR mutation analysis assay is the first test to be sold through LabCorp's collaboration with Qiagen's lab readiness program. That program is designed to speed patient access to companion diagnostics soon after FDA has approved a new treatment and its associated test.
Qiagen has an exclusive license from Columbia University to the therascreen FGFR technology.
LabCorp and its Covance drug development unit have been developing and selling companion diagnostic tests for the past two decades, and efforts in this area of precision medicine have accelerated recently. LabCorp said it has collaborated with more than 75 clients on over 150 projects to develop new companion diagnostic tests since 2018.
Revenue from all aspects of companion diagnostics grew more than 30% across the enterprise in the first quarter, compared with the year before, LabCorp said in April.
The company's pipeline includes new companion diagnostics for lung, breast and colorectal cancer, in addition to bladder cancer. It is also looking to develop companion tests for pan-tumor disease areas.
Qiagen, a Netherlands-based company that sells assay technologies for molecular diagnostics, applied testing, pharmaceutical and academic research, derives about half of its net sales from its molecular diagnostics business.
Bladder cancers are associated with genetic mutations present in the patient's bladder or urothelium, the lining of the lower urinary tract. Bladder cancer is the sixth most common type of cancer in the United States. Urothelial cancer, or transitional cell carcinoma, is the most prevalent form of bladder cancer.
There is a high unmet need among patients who are looking for new treatment options with advanced metastatic bladder cancer. For patients with metastatic disease, outcomes are dire, with a relative five-year survival rate of only 5%.