Pangea Laboratory Receives FDA Breakthrough Device Designation for the Bladder CARE™ Assay

Promising Advancement for the Early Detection of Urothelial Cancers

TUSTIN, Calif., Dec. 20, 2023 /PRNewswire/ — Pangea Laboratory has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its non-invasive Bladder CARE™ Assay, intended 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.

The Bladder CARE™ Assay measures the methylation levels of three urothelial cancer-specific DNA biomarkers in a single qPCR reaction. It markedly outperforms traditional cytology and other FDA-approved tests, with sensitivities and specificities of 93.5% and 92.6% for the detection of bladder cancer, 96.0% and 88.0% for UTUC, and 89.0% sensitivity for carcinoma in-situ, which is notoriously difficult to detect. An easy-to-use urine collection kit stabilizes the specimen for room-temperature shipping, further reducing the burden on patients and healthcare providers.

“The Bladder CARE™ Assay’s quantitative nature sets it apart from other tests,” highlighted Dr. Siamak Daneshmand, Professor of Urology (Clinical Scholar) and Director of Clinical Research at the USC Institute of Urology. “This characteristic holds significant potential in providing clinicians with valuable insights into patient response to anticancer treatments.”

An estimated 82,290 people in America were diagnosed with bladder cancer in 2023. Existing diagnostic methods can cause significant patient discomfort or have the potential for delayed or inaccurate results, highlighting the critical need for reliable non-invasive tests like the Bladder CARE™ Assay.

This need is particularly urgent for UTUC, which is closely associated with bladder cancer but has a poorer prognosis and previously could only be detected through invasive means. Prospective collaborative research led by Dr. Hooman Djaladat, Dean’s Professor of Urology at USC, highlights the Bladder CARE™ Assay’s superior negative predictive value and diagnostic accuracy for UTUC, featuring 96.7% sensitivity for high-grade and 100.0% for low-grade tumors, a stark contrast to urine cytology at 43.3% and 0.0% respectively.

Dr. Larry Jia, Founder and CEO of Pangea Laboratory, noted, “The FDA’s recognition of the Bladder CARE™ Assay validates its potential to reshape cancer diagnostics, making effective and patient-friendly detection a reality.”

 “The breakthrough results from a successful collaboration with Dr. Siamak Daneshmand and Dr. Hooman Djaladat and their teams at USC Urology,” said Dr. Paolo Piatti, Project Manager at Pangea Laboratory. “We anticipate further fruitful partnerships with experts in the field to enhance the accessibility of the Bladder CARE™ Assay.”

Pangea Laboratory is poised to commence multicenter clinical trials as the next step toward obtaining premarket approval for the Bladder CARE™ Assay.

About Pangea Laboratory

Founded in 2014, Pangea Laboratory is a diagnostics company dedicated to simplifying cancer diagnosis. Clinical Laboratory Improvement Amendments (CLIA) certified and College of American Pathologists (CAP) accredited, Pangea focuses on the sensitive, early, and non-invasive detection of critical health conditions.

About FDA Breakthrough Device Designation

An initiative that expedites the review of innovative medical devices addressing life-threatening or irreversibly debilitating conditions, requiring enhanced effectiveness and significant advantages over existing cleared or approved alternatives.

Media Contact: Abigail Kang, akang@pangealab.com 

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SOURCE Pangea Laboratory