Medical Technology

Pancreatic Cancer Test Validated For Newly Diagnosed Diabetes

This summary was published in It was not peer reviewed.

Key Takeaways

  • Researchers have developed and validated a new screening test to detect pancreatic cancer in people who have recently diagnosed diabetes.

  • The new test relies on detecting a very distinctive epigenetic marker of pancreatic cancer in the blood, the appearance of 5-hydroxymethylcytosine (5hmC) in cell-free DNA that’s isolated from a 20 mL blood specimen.

  • This technology is cost-effective and can be employed to detect cancer occult in the early stages of patients at high risk. This can improve survival rates.

Why It’s Important

  • Pancreatic cancer has the lowest overall survival rate among all cancers, with 5-year relative survival rates of 10 percent.

  • The majority of patients suffering from pancreatic cancer have few or no symptoms at the beginning of the disease which is why they are usually not diagnosed until the late stages, when there have already metastases, at which stage it is often too late to undergo curative surgery.

  • New-onset diabetes is an indicator of pancreatic cancer; more than 50% of patients diagnosed with pancreatic cancer have a history of diabetes mellitus.

  • The authors concluded that the screening tool they designed and validated is accurate and scalable, as well as cost-effective. They also concluded that it can allow early detection of pancreatic cancers that are occult in people such as people with diabetes who are newly diagnosed.

  • This new test has the potential to increase the survival rate of people suffering from new-onset diabetes because earlier diagnosis of pancreatic cancer facilitates the early beginning of cancer treatment.

Study Design

  • The derivation phase of the study used blood samples from 89 patients with pancreatic cancer and 596 people without cancer.

  • The validation phase included blood samples from 79 patients with pancreatic cancer, 163 people without any type of cancer, and 506 people who had a non-pancreatic type of cancer (35, 228 lungs, and 97).

  • A second validation assessment involved specimens from 91 people with new-onset diabetes, including 29 who were diagnosed with pancreatic cancer and 62 with no cancer.

  • The participants were aged between 45 and 75 years old and were enrolled at any of the 146 US sites.

  • The test identified 5-hmC as cell-free DNA in plasma specimens taken from 20 mL of a person’s blood

  • The researchers employed machine learning to design an algorithm for predicting pancreatic cancer, based on the 5hmC signatures found in the DNA extracted from the cells of each subject.

Key Results

  • The model under test had a mean sensitivity of 61.1 percent and a specificity of 97.6 percent during the derivation phase.

  • The model that was derived could account (had an area that was below the curve of receiver operating characteristic for) 87%-96% pancreatic cancers. The exact number will vary depending on the stage of cancer, I-IV.

  • The screening test was conducted on patients with pancreatic carcinoma (42 percent with early-stage disease) and healthy controls. It revealed the specificity of 51.9 percent and 100% specificity..

  • Similar results were observed in patients with new-onset diabetes, where the test had 55.2% sensitivity and 98.4% specificity.

  • Patients with and without diabetes had similar 5hmC signatures, which suggests that the test is able to detect pancreatic cancer in diabetics and non-diabetics.

Implied Limitations

Study Disclosures

  • This study was funded by Bluestar Genomics. Bluestar Genomics was involved in the study’s design, execution analysis, interpretation, and analysis.

  • Bluestar Genomics shareholders and employees are all authors.

This is a summary from a preprint research study “Validation a Pancreatic Cancer Test for New-Onset Diabetes by using cell-free DNA 5-hydroxymethylation signs,” written by Bluestar Genomics and made available to Medscape. This study has not been peer-reviewed. The full text of this study can be found on

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