FDA grants Bladder CARE Assay Breakthrough Therapy Designation for bladder cancer/UTUC

The FDA has granted Breakthrough Therapy Designation to the Bladder CARE Assay for the quantitative urine-based diagnosis of bladder cancer and upper tract urothelial carcinoma (UTUC) in patients presenting with hematuria and suspected of having either cancer. ¹

The Breakthrough Therapy Designation, which will expedite the development and regulatory review of Bladder CARE in this setting, is supported by findings from a clinical evaluation of the device that were published in the journal Clinical Epigenetics

According to Pangea Laboratory, the developer of the device, the Bladder CARE Assay “measures the methylation levels of three urothelial cancer-specific DNA biomarkers in a single qPCR reaction.”¹

"The Bladder CARE Assay's quantitative nature sets it apart from other tests," Siamak Daneshmand, MD professor of Urology (Clinical Scholar) and director of Clinical Research at the USC Institute of Urology, stated in a news release.¹ "This characteristic holds significant potential in providing clinicians with valuable insights into patient response to anticancer treatments."

The Breakthrough Therapy Designation, which will expedite the development and regulatory review of Bladder CARE in this setting, is supported by findings from a clinical evaluation of the device that were published in the journal Clinical Epigenetics.² In the analysis, Bladder CARE was used to evaluate urine samples from 136 healthy subjects and 77 patients with bladder cancer.

The analysis showed that as a test for bladder cancer detection in urine samples, the Bladder CARE had an overall sensitivity of 93.5% and a specificity of 92.6%. The positive predictive value of Bladder CARE was 87.8% and the negative predictive value was 96.2%.²

The researchers also noted in their publication that, “Bladder CARE has a limit of detection (LOD) as low as 0.046%, which equates to detecting 1 cancer cell for every 2200 cells analyzed,” adding, “The low LOD of the test and the measurement of epigenetic biomarkers make Bladder CARE a good candidate for the early detection of bladder cancer and possibly for the routine screening and surveillance of bladder cancer patients.”²

Pangea also noted in the news release that Bladder CARE has demonstrated an overall sensitivity of 96.0% and a specificity of 88.0% in patients with UTUC.¹

The company now plans to launch multicenter clinical trials of Bladder CARE.

"The FDA's recognition of the Bladder CARE Assay validates its potential to reshape cancer diagnostics, making effective and patient-friendly detection a reality," Larry Jia, MD, founder and CEO of Pangea, stated in the news release.¹

Resources

1. Pangea Laboratory Receives FDA Breakthrough Device Designation for the Bladder CARE™ Assay. Published online and accessed December 20, 2023. https://www.prnewswire.com/news-releases/pangea-laboratory-receives-fda-breakthrough-device-designation-for-the-bladder-care-assay-302019655.html

2. Piatti P, Yap Chew YC, Suwoto M, et al. Clinical evaluation of Bladder CARE, a new epigenetic test for bladder cancer detection in urine samples. Clin Epigenetics. 2021;13(1):84. doi: 10.1186/s13148-021-01029-1.