FDA Grants Breakthrough Device Designation for PDACatch Assay to Detect PDAC

The FDA has granted a breakthrough device designation to the PDACatch assay, a novel DNA methylation-based liquid biopsy assay, for the detection of pancreatic adenocarcinoma (PDAC) in patients who are at high-risk for the disease, according to Singlera Genomics.¹

"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," said Qiang Liu, chief operating officer, of Singlera Genomics, in a press release.

As a cancer with 1 of the highest mortality rates, in part due to the majority of diagnoses being late-stage, PDAC has a 5-year survival rate of less than 10%. Because of this, there is an unmet need in the space for screening options for patients who are at high risk for this disease.

The PDACatch assay utilizes a proprietary library construction approach and methylation haplotypes to reach high conversion rates and cancer detection sensitivity. The technology is based on Singlera's MethylTitan platform and previously showed early detection of 5 types of cancer 4 years prior to conventional diagnosis.

The PDACatch assay is able to detect methylation patterns in circulating tumor DNA in blood that comes from early-stage pancreatic adenocarcinomas and precancerous pancreatic lesions. Some of these include intraductal papillary mucinous neoplasms (IPMN) and mucinous cystic neoplasms (MCN), potentially allowing earlier detection and intervention for high-risk PDAC patients.

According to data presented at the American Association for Cancer Research Annual Meeting 2022, investigators wanted to find biomarkers carrying a PDAC-specific DNA methylation signature in blood cell-free DNA, and aimed to develop and validate a non-invasive test that could detect PDAC.²

Investigators sought to evaluate the PDACatch assay, which was validated on an independent sample set to show its efficacy for pancreatic cancer methylation signature detection. Findings presented at AACR showed that the PDACatch assay was performed on 91 PDAC plasma and 84 healthy plasma samples which were collected from commercial biobanks. The assay predicted PDAC from healthy with accuracy which remained high for classification of both stage I and early-stage samples.

These findings demonstrate that the PDACatch assay achieved a high accuracy for detecting PDAC at early stages, prove its potential in screening effectiveness, and support the breakthrough device designation granted by the FDA.

"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,” added Liu, in the press release.¹

REFERENCES:

Singlera Genomics receives FDA breakthrough device designation for PDACatch, a liquid biopsy assay for pancreatic cancer detection in high-risk individuals. News release. Singlera Genomics. May 8, 2023. Accessed May 9, 2023. https://prn.to/3HV5A2m

Gore AJ, Dang J, Fung A, et al. Non-invasive early detection of pancreatic ductal adenocarcinoma using methylation signatures in circulating tumor DNA [abstract]. American Association for Cancer Research Annual Meeting 2022; April 8-13. Philadelphia, PA.