Singlera Genomics, a company focused on non-invasive genetic testing, has received the Food and Drug Administration (FDA) Breakthrough Device Designation for its PDACatch assay.

PDACatch is a novel DNA methylation-based liquid biopsy assay intended for the early-detection of pancreatic adenocarcinoma (PDAC) in people who are at high risk for the disease.

PDAC is one of the most serious forms of cancer, partly due to late-stage diagnoses in majority cases, where five-year survival rate for PDAC is less than 10%.

Singlera designed the PDACatch assay based on its MethylTitan platform, which uses a unique library construction approach and methylation haplotypes to achieve superior cancer detection.

According to the previous study published in Nature Communications, the technology has enabled early detection of five types of cancer, four years before the conventional diagnosis.

The PDACatch assay detects methylation patterns in circulating tumour DNA (ct-DNA) in blood originating from early-stage pancreatic adenocarcinomas and pancreatic lesions.

The assay allows earlier detection and intervention for patients at high-risk of developing PDAC.

Singlera Genomics COO Qiang Liu said: “We are very excited that the FDA has recognized the PDACatch assay as a Breakthrough Device. This is a big milestone for Singlera.

“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 program to obtain continued guidance and prioritized reviews of our clinical trials and pre-market approval processes.”

FDA grants Breakthrough Device Designation to certain devices that has the potential to provide effective treatment or diagnosis of serious disease, addressing an unmet medical need.

The Breakthrough Device Designation enables Singlera to offer PDACatch assay as a screening option for patients at high risk for pancreatic cancer, in less time.

The company is currently in preparing to conduct a clinical study to further evaluate and pursue pre-market approval for the PDACatch assay.