LMC Pathology Services, the Aurora Diagnostics lab in Las Vegas, Nevada, was chosen by Ventana Medical Systems, a Roche Diagnostics Company, as one of the first laboratories in the United States to provide the FDA-approved VENTANA PD-L1 (SP142) Assay.
The complementary assay is an immunohistochemical tissue assay corresponding with the release of TECENTRIQ (atezolizumab).
The Food and Drug Administration (FDA) approved TECENTRIQ (atezolizumab) on May 18 for the treatment of invasive Urothelial Bladder Cancer.
Genentech’s TECENTRIQ™ (atezolizumab, anti-PDL1; MPDL3280A) is the first cancer immunotherapy for the treatment of people with locally advanced or metastatic urothelial carcinoma who exhibit disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).
Urothelial carcinoma accounts for 90 percent of all bladder cancers in the U.S. in 2014. The cancer is also found in the renal pelvis, ureter and urethra.
Atezolizumab received Breakthrough Therapy Designation by the FDA in May 2014 for the treatment of people whose metastatic bladder cancer expresses the protein PD-L1 (programmed death ligand-1).
Breakthrough Therapy Designation expedites the development and review of medicines intended to treat serious or life-threatening diseases and ensure that people have access to them through FDA approval as soon as possible. Atezolizumab is also being studied in a number of other cancers.
"This is a revolutionary breakthrough in managing the treatment of bladder cancer," said Joel S. Bentz, MD, FCAP the Medical Director of Aurora Diagnostics LMC Pathology Services. "Our lab is honored to be one of a handful of labs in the country that will be performing this test, and our pathologists look forward to assisting our clients in interpreting the results as they plan treatments for their patients."
"Aurora Diagnostics and the Aurora Research Institute provided services that accelerated the approval of this important complementary diagnostic test," said Michael Null, President of Aurora Research Institute. "We are excited to be a part of this effort."