BURLINGTONLabCorp has launched a new diagnostic test that brings precision medicine to certain cancer patients.

The therascreen FGFR mutation analysis assay, recently approved by the U.S. Food and Drug Administration, can be used to assess which patients with a type of bladder cancer should take Balversa, a newly approved drug developed by Janssen Biotech.

The assay, known as a companion diagnostic because it is paired with a specific drug, was developed by QIAGEN, a Netherlands-based company that develops companion diagnostics for pharmaceutical and biotechnology companies.

Therascreen will help identify patients with urothelial cancer whose tumors have certain alterations in the fibroblast growth factor receptor 3 (FGFR3) gene. Those patients are best suited to benefit from Balversa, a targeted therapy for adults with locally advanced or metastatic cancer that has progressed during or following chemotherapy.

Test available through QIAGEN program

Therascreen will be available through LabCorp’s participation in QIAGEN’s Day-One Lab Readiness program, which accelerates access to innovations in precision medicine.

“Using our test to help guide treatment decisions in urothelial cancer will address a high unmet medical need among patients,” said Thierry Bernard, senior vice president and head of QIAGEN’s Molecular Diagnostics Business Area.

Urothelial cancer, or transitional cell carcinoma, is the most prevalent form of bladder cancer, which is the sixth most common type of cancer in the United States. More than 80,470 new cases of bladder cancer will be diagnosed in 2019, leading to about 17,600 deaths, according to the American Cancer Society.

For patients with metastatic disease, treatments are limited and outcomes are bleak, with a relative five-year survival rate of only 5 percent.

The efficacy of Balversa was studied in a clinical trial involving 87 patients with locally advanced or metastatic bladder cancer, with FGFR3 or FGFR2 genetic alterations, that had progressed following treatment with chemotherapy.

The overall response rate in those patients was 32.2 percent, with 2.3 percent having a complete response and almost 30 percent having a partial response. The response lasted for an average of about five-and-a-half months.

Therapy targets genetic alterations in cell growth regulators

Balversa is an FGFR kinase inhibitor. It works by targeting genetic alterations in FGFRs, which regulate cell growth and division during development and tissue repair.

The FDA’s accelerated approval of Balversa in April “represents the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

“We’re in an era of more personalized or precision medicine, and the ability to target cancer treatment to a patient’s specific genetic mutation or biomarker is becoming the standard, with advances being made in new disease types,” Pazdur said.

LabCorp committed to precision testing

“LabCorp is committed to bringing precision testing to patients as quickly as possible,” said Marcia Eisenberg, Ph.D., chief scientific officer of LabCorp Diagnostics. “Our work on studies supporting regulatory approval of the therascreen FGFR mutation analysis companion diagnostic for Balversa, and our commitment to make the test available to physicians and patients as soon as possible after approval, aligns with our mission to improve health and improve lives.”

LabCorp said that over the last year it has collaborated with more than 75 clients on over 150 projects targeted to develop new companion diagnostic tests.

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

LabCorp is a global life sciences company that provides clinical laboratory and drug development services. It employs about 3,600 people in Alamance County, where it is the largest private employer, and about 7,300 across North Carolina. Its global workforce includes nearly 60,000 employees.

LabCorp reported revenue of more than $11 billion in 2018.