The US Food and Drug Administration (FDA) has granted breakthrough device designation to Singlera Genomics’ PDACatch liquid biopsy assay.
The new DNA methylation-based assay is intended to identify pancreatic adenocarcinoma in individuals at high disease risk.
PDACatch is based on the company’s MethylTitan platform, which deploys a library construction approach and methylation haplotypes to yield better conversion rates and cancer detection sensitivity.
Previously, the technology was shown to enable the early identification of five cancer types four years before conventional diagnosis.
The test is capable of identifying methylation patterns in circulating tumour DNA in blood, which originate from both early-stage pancreatic adenocarcinomas and precancerous pancreatic lesions such as intraductal papillary mucinous neoplasms and mucinous cystic neoplasms.
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It will facilitate early detection and intervention for high-risk PDAC patients.
The company is undertaking the launch of a prospective study and clinical trial to assess and secure pre-market approval for PDACatch.
Singlera Genomics COO Qiang Liu said: “PDACatch is the first ever liquid biopsy tool to detect and monitor pancreatic adenocarcinoma. Early detection and monitoring of patients at high risk for pancreatic cancer will make a significant impact on these individuals’ quality of life.
“We look forward to working with the FDA as part of the Breakthrough programme to obtain continued guidance and prioritised reviews of our clinical trials and pre-market approval processes.”
