Singlera Genomics, a company focused on the application of novel DNA methylation technologies to genetic diagnosis, has received Breakthrough Device Designation from the FDA for its PDACatch assay, a novel DNA methylation-based liquid biopsy assay for the detection of pancreatic adenocarcinoma in individuals at high risk for the disease.
Pancreatic adenocarcinoma (PDAC) is one of the most deadly forms of cancer, in part due to the majority of diagnoses being late-stage; the five-year survival rate for PDAC is less than 10%. 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 goal of the program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval.
With Breakthrough Device Designation, the PDACatch assay could become available as a screening option for patients at high risk for pancreatic cancer sooner.
“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,” says Qiang Liu, COO of Singlera Genomics. “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.”
Singlera Genomics is in the process of launching a prospective study and clinical trial to further evaluate and obtain pre-market approval for the PDACatch assay.