Pangea Laboratory

We are thrilled to announce a significant milestone in our journey towards transforming cancer diagnostics: Pangea Laboratory has been granted Breakthrough Device Designation by the FDA's Center for Devices and Radiological Health (CDRH) for our Bladder CARE™ Assay.

This non-invasive epigenetic assay has been approved for the quantitative detection of bladder cancer and Upper Tract Urothelial Carcinoma (UTUC) DNA from urine specimens, utilizing the unique Pangea collection device. Our assay is poised to complement the current standard diagnostic procedures for the initial diagnosis of bladder cancer and UTUC in patients presenting with hematuria and suspected of having either cancer.

This recognition from the FDA is a testament to our team's unwavering commitment to advancing cancer diagnostics and underscores the potential impact of the Bladder CARE™ Assay in improving the accuracy and speed of urothelial cancer detection, ultimately enhancing patient outcomes.

Our sincere thanks to our research collaborators at USC Urology - Dr. Siamak Daneshmand, Dr. Hooman Djaladat, Dr. Gangning Liang, Dr. Alireza Ghoreifi, Dr. Sanam Seyedian, Dr. Saum Ghodoussipour, and everyone whose work has helped us achieve this breakthrough.

This Bladder Cancer Awareness Month, we're thrilled to share that the results of our joint work with the USC Institute of Urology was acknowledged and cited under "Future Directions" in the inaugural AUA/SUO guidelines for the Diagnosis and Management of Non-Metastatic Upper Tract Urothelial Carcinoma (UTUC).

Considering that approximately 30% of UTUC patients have a history of bladder cancer and 8-13% have concurrent bladder cancer at diagnosis, this recognition underscores the importance of research and innovation in improving the detection and treatment for urothelial cancers.

Read the full publication here: https://www.auajournals.org/doi/abs/10.1097/JU.0000000000003188

Explore the latest guidelines here: https://www.auanet.org/guidelines-and-quality/guidelines/non-metastatic-upper-tract-urothelial-carcinoma

We're celebrating in style here at Pangea Laboratory!

Thank you to every single one of our team members for your dedication, expertise, and commitment to making a difference in our patients' lives.

Learn how our research is revolutionizing urological cancer detection at the American Association for Cancer Research (AACR) Annual Meeting!

Drop by booth #2273 to learn more about how we're using DNA methylation biomarkers for the non-invasive and highly sensitive early detection of Bladder Cancer and UTUC.

Just published in The Journal of Urology: A Urine-based DNA Methylation Marker Test to Detect Upper Tract Urothelial Carcinoma: A Prospective Cohort Study.

Congratulations to our team members Paolo Piatti, Yap Ching Chew, Benjamin Jara, Lucy Sanossian, and Taikun Yamada on the publication of another paper.

We would like to thank the USC Institute Of Urology team at the USC Norris Cancer Center, especially Drs. Alireza Ghoreifi, Sanam Ladi Seyedian, Hooman Djaladat, and Siamak Daneshmand for their outstanding work exploring new clinical applications for Bladder CARE™ and showing how it significantly outperforms existing non-invasive modalities to detect UTUC.

Read it here: https://www.auajournals.org/doi/abs/10.1097/JU.0000000000003188