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%.
Scancell initiates SCOPE trial's iSCIB1+ cohort
Bio-Thera Solutions' BAT8006 phase II Study receives US FDA IND approval
Poseida Therapeutics names new chief medical officer
Biocytogen and ABL Bio collaborate on development of new bispecific antibody-drug conjugates
BioVaxys Technology announces non-brokered private placement
Senhwa Biosciences doses first subject in phase II study of Silmitasertib
Antennova completes first dosing cohort in Phase one study of ATN-031
M8 Pharmaceuticals collaborates with SERB Pharmaceuticals
BerGenBio ASA starts Phase 2a portion of BGBC016 clinical study of bemcentinib
Phanes Therapeutics receives FDA Fast Track designation for PT886