Pangea Bladder CARE Assay
The FDA has granted Breakthrough Therapy Designation to Pangea for its Bladder CARE Assay. Breakthrough Therapy Designation expedites the development and regulatory review of the Bladder CARE assay. The company now plans to launch multicenter clinical trials.
Bladder CARE is a non-invasive epigenetic assay for the detection of bladder cancer and Upper Tract Urothelial Carcinoma (UTUC) in urine specimens. The test is indicated for patients presenting with hematuria and suspected of having cancer.
The Bladder CARE Assay measures the methylation level of three bladder cancer-specific DNA biomarkers: TRNA-Cys, SIM2, and NKX1-1. These loci are hypermethylated in both noninvasive and invasive bladder cancer. A proprietary algorithm is used to express results as a Bladder CARE™ Index (BCI). Patients with a BCI < 2.5 are considered to be negative for the presence of bladder cancer, while patients with a BCI > 2.5 and > 5 are classified as high-risk and positive, respectively.
A preliminary clinical study sponsored by Pangea evaluated urine samples from 136 healthy subjects and 77 patients with bladder cancer. The Bladder CARE assay had an overall sensitivity of 93.5% and a specificity of 92.6% for the detection of cancer. The positive predictive value was 87.8% and the negative predictive value was 96.2%. The company claimed that the lower limit of detection was 1 cancer cell for every 2200 cells analyzed.
Pangea also noted in its news release that the Bladder CARE assay has a sensitivity of 96.0% and a specificity of 88.0% for the detection of upper tract urothelial cancer (UTUC).
Urine samples are collected at home or at a medical facility using the company’s Urine Collection Kit. Immediately after collection, a preservative is added to the urine sample which stabilizes DNA for up to 30 days at ambient temperature. The sample is then mailed to the company’s laboratory in California. The company claims that results will be reported to the ordering physician within 24 to 48 hours of receipt of the sample.
References
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
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.
Broderick JM. FDA grants Bladder CARE Assay Breakthrough Therapy Designation for bladder cancer/UTUC. Urology Times. Dec 20, 2023.
