Research & Development
New Qiagen Therascreen FGFR Mutation Analysis Companion Diagnostic for Bladder Cancer Now Available from LabCorp
16 May 2019 - - US-based life sciences company LabCorp (NYSE: LH) is offering a newly-approved companion diagnostic by the US Food and Drug Administration, the therascreen FGFR mutation assay by RGQ RT-PCR, which is now available for ordering from LabCorp and its Integrated Oncology specialty laboratory, the company said.

Qiagen developed the assay, which is used to assess the eligibility of patients with urothelial cancer for treatment with the newly approved FGFR kinase inhibitor, BALVERSA (erdafitinib), developed by Janssen Biotech, Inc. (Janssen).

This is the first FDA-approved biomarker-driven, targeted therapy for the treatment of adults with locally advanced or metastatic urothelial carcinoma with susceptible fibroblast growth factor receptor 3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Since 2018, the company collaborated with more than 75 clients on over 150 projects targeted at the development of new companion diagnostic tests.

The availability of this new assay reflects LabCorp's continued leadership in precision medicine.

For more than 20 years, LabCorp Diagnostics and Covance Drug Development have been involved in the development, commercialisation and launch of companion and complementary diagnostics, and together they have supported more FDA-approved companion diagnostics than any other company.

The therascreen FGFR mutation analysis assay is the first to be introduced through LabCorp's participation in Qiagen's Day-One Lab Readiness program, under which LabCorp will make novel companion diagnostics available for use by physicians soon after the FDA has approved a new treatment and its associated test.

Urothelial cancer, or transitional cell carcinoma, is the most prevalent form of bladder cancer, which constitutes the sixth most common type of cancer in the US.

According to the American Cancer Society, more than 80,470 new cases of bladder cancer will be diagnosed in 2019, and will result in approximately 17,600 deaths.

For patients with metastatic disease, outcomes are dire, with a relative five-year survival rate of only 5%.