Singlera Genomics Liquid Biopsy Technology Receives FDA Breakthrough Medical Device Designation

On May 8, Singlera Genomics announced that its self-developed PDACatch test, a novel DNA methylation-based liquid biopsy test for detecting pancreatic cancer in high-risk populations, has been granted Breakthrough Medical Device designation by FDA.

Singlera Genomics will exhibit at the 20th CACLP and the 3rd CISCE to be held at Nanchang Greenland International Expo Center on May 28-30, 2023, with booth No. B2-2010.

Publicly available information shows that Singlera Genomics was founded in 2014 and has R&D bases in Shanghai, China and San Diego, USA. The company aims to attack early screening and diagnosis of cancer, and is committed to developing methylation detection technologies and providing technologies and products for risk assessment, early screening and diagnosis, medication guidance and recurrence monitoring of high-incidence cancers.

The PDACatch assay detects methylation patterns in blood ctDNA derived from early stage pancreatic cancer and precancerous lesions such as intraductal papillary mucinous neoplasm (IPMN) and mucinous cystic neoplasm (MCN), potentially allowing earlier detection of risk and timely intervention in patients with high-risk pancreatic cancer.

Publicly available information indicates that to receive FDA Breakthrough Medical Device designation, a testing device must address an unrealized medical need and demonstrate the potential to provide a more effective treatment or diagnosis for a life-threatening or irreversible debilitating disease or condition. The goal of the program is to provide patients and healthcare providers with timely access to these medical devices by accelerating development, evaluation and review while retaining the statutory criteria for premarket approval. With breakthrough medical device designation, the PDACatch test has the potential to serve earlier testing of populations at high risk of developing pancreatic cancer.

We are very pleased that the FDA has granted Breakthrough Medical Device designation to the PDACatch assay, the first liquid biopsy tool to aid in the detection of pancreatic cancer, its early detection and monitoring of high-risk populations will have a significant impact on the quality of life of this population," said Qiang Liu, Chief Operating Officer of Singlera Genomics. We look forward to working with the FDA as part of the Breakthrough Medical Device Certification Program, where we will receive ongoing guidance and priority review of our clinical trial and premarket approval process. Singlera Genomics is initiating prospective studies and clinical trials to further evaluate and obtain premarket approval for the PDACatch assay tool.