FDA Grants Breakthrough Device Designation to Pancreatic Cancer Assay for Early Detection in Patients


A proprietary noninvasive test designed to detect pancreatic cancer has been granted breakthrough device designation by the FDA for patients with new-onset diabetes.

A proprietary noninvasive test designed to detect pancreatic cancer, has been granted breakthrough device designation by the FDA for patients with new-onset diabetes, announced Bluestar Genomics, in a press release.1

Roughly 25% of the 60,000 patients diagnosed with pancreatic cancer were found to have new-onset diabetes prior to their cancer diagnosis. With its new designation from the FDA, the company hopes to screen an estimated 1 million adults diagnosed annually with new-onset diabetes in the United States for detection of potential pancreatic cancer that would also help with pancreatic cancer treatment to improve outcomes in these patients.

“Late diagnosis deprives patients of potentially curative treatments and impacts survival rates,” said Kelly Bethel MD, chief medical officer, Bluestar Genomics, in a statement. “In contrast, when detected at an early stage, patients can be eligible for surgery, which can be curative. Therefore, early detection is paramount for giving patients better treatment options to potentially improve outcomes.”

The 5hmC assay uses a standard blood draw to assess whether a patient has an abnormal epigenomic and genomic signature associated with pancreatic cancer. State-of-the-art machine learning coupled with the DNA-based 5-hydroxymethylcytosine (5hmC) biomarker as a screening method to detect cancer sooner are used for the assay, making it unique compared with other liquid biopsy assays.

Promise for the use of the 5hmC assay to detect pancreatic cancer was demonstrated in a circulating cell-free DNA–based epigenomic study. Plasm from 51 subjects who underwent surgical resection for pancreatic cancer with a confirmed diagnosis of pancreatic ductal adenocarcinoma was analyzed, along with plasma from 41 non-cancer subjects. By looking for a filtered set of genes, including GATA4GATA6PROX1ONECUT1, MEIS2, YAP1TEAD1PROX1ONECUT1ONECUT2IGF1, and IGF2, the assay was able to identify significantly different epigenomic signatures, which included areas of enrichment and absence of 5-hydroxymethylation. Detection of changes in 5hmC were able to classify pancreatic cancer even at early stages of the disease.2

The feasibility and validity of the test were also shown in other studies that were included in the body of research leading to the breakthrough device designation. A large clinical validation study is also underway to confirm the ability of the assay specifically for pancreatic cancer detection in patients with new-onset diabetes.

“Currently, there are no screening methods to enable early detection of pancreatic cancer, while early, accurate detection has the potential to significantly improve prognosis by enabling better therapeutic options for patients,” said Samuel Levy, Ph.D., chief executive, and scientific officer, Bluestar Genomics, in a statement. “With FDA’s designation, combined with continued collaboration with top research institutions, our goal is to accelerate important clinical validation studies to bring our pancreatic cancer test to market in the coming years and continue to extend our efforts toward a multi-cancer screening test.”

With a breakthrough device designation, the development of Bluestar Genomics’ 5hmC assay will be accelerated.


1. Bluestar Genomics receives FDA breakthrough device designation for first-of-its-kind pancreatic cancer screening test. News release. Bluestar Genomics. March 31, 2021. Accessed April 2, 2021.

2. Guler GD, Ning Y, Ku CJ, et al. Detection of early stage pancreatic cancer using 5-hydroxymethylcytosine signatures in circulating cell free DNA. Nat Commun. 2020;11(1):5270. doi:10.1038/s41467-020-18965-w

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