Singlera Genomics and Breakthrough Genomics partnered with the University of Pittsburgh to run a preclinical study of the BT‑Reveal early pancreatic cancer test, which analyzes cfDNA methylation using Singlera’s mTitan platform. The BT‑Reveal test holds FDA breakthrough device designation and is available as an LDT for high‑risk patients through Breakthrough’s CLIA lab. The preclinical collaboration with Pitt aims to assess the test’s efficacy in high‑risk screening, a critical step toward a longitudinal FDA study. Singlera’s COO highlighted the goal of moving toward large‑scale FDA‑regulated screening if preclinical results support clinical validity. Early detection for pancreatic cancer remains a high unmet need; this study could inform next steps for regulatory testing and broader clinical deployment of methylation‑based liquid biopsy assays.
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