Therapy Areas: Devices
US FDA grants Breakthrough Device Designation for Singlera Genomics' PDACatch assay
9 May 2023 -

Singlera Genomics, a US-based company focused on the application of novel DNA methylation technologies to genetic diagnosis, announced on Monday that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its PDACatch assay, a novel DNA methylation-based liquid biopsy assay for the detection of pancreatic adenocarcinoma (PDAC) in individuals at high risk for the disease.

PDAC is one of the most deadly forms of cancer, in part due to the majority of diagnoses being late-stage.

The PDACatch assay 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. This technology was previously demonstrated to allow early detection of five types of cancer four years prior to conventional diagnosis (Nature Communications). The PDACatch assay detects 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 (IPMN) and mucinous cystic neoplasms (MCN), potentially allowing earlier detection and intervention for high-risk PDAC patients.

To qualify for Breakthrough Device Designation, a device must address an unmet medical need and show that it has the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The company is in the process of introducing a prospective study and clinical trial to further assess and receive pre-market approval for the PDACatch assay.