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# Singlera ‘Breakthrough’ on Pancreatic Cancer Assay
- URL: https://www.fdaweb.com/singlera-breakthrough-on-pancreatic-cancer-assay/
- Published: 2023-05-08T12:00:00.000Z
- Updated: 2026-09-14T18:30:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154388

FDA has granted Singlera Genomics a breakthrough device designation for its PDACatch assay, a DNA methylation-based liquid biopsy assay for detecting pancreatic adenocarcinoma in individuals at high risk for the disease. The device is based on Singlera's MethylTitan platform, which “utilizes a proprietary library construction approach and methylation haplotypes to achieve unparalleled conversion rates and cancer detection sensitivity,” the company says. “This technology was previously demonstrated to allow early detection of five types of cancer four years prior to conventional diagnosis ([Nature Communications](https://www.nature.com/articles/s41467-020-17316-z?ref=fdaweb.com)).”

The assay works by detecting methylation patterns in circulating tumor DNA in blood that originate from early stage pancreatic adenocarcinomas and precancerous pancreatic lesions such as intraductal papillary mucinous neoplasms and mucinous cystic neoplasms (MCN), which could allow earlier detection and intervention for high-risk patients, Singlera says.

The company says it is preparing to launch a prospective study and clinical trial to further evaluate and obtain pre-market approval for the device.