Novel gene-expression blood test detects nine in ten early stage pancreatic cancers

A novel gene-expression blood test developed by researchers at Kanazawa University has detected 90 per cent of early-stage pancreatic cancers in a pilot study offering hope as a screening tool in one of the world's most lethal cancers

Researchers at Kanazawa University in Japan have developed a blood‑based gene‑expression test that may enable much earlier detection of pancreatic cancer which could improve long‑term survival.

Pancreatic cancer is one of the most malignant of all cancers. In Japan, the five‑year relative survival rate stood at just 8.5 per cent between 2009 and 2011, according to data from the country’s National Cancer centre. Curative treatment is only possible when the disease is caught early enough for surgical resection to be performed, yet early‑stage pancreatic cancer accounts for only two to three per cent of diagnosed cases, largely because it is so difficult to detect.

This diagnostic gap has long been regarded as a major factor behind the cancer's poor prognosis, and there is an urgent need for non‑invasive methods – particularly blood‑based biomarkers – which are able to identify the disease effectively while it is still at its earliest stage.

A research group led by Dr Taro Yamashita, dean of the Graduate School of Advanced Preventive Medical Sciences and professor of gastroenterology at the Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan, had previously developed a pancreatic cancer diagnostic test known as 'Panregza', which combines gene‑expression patterns drawn from peripheral whole blood with the serum tumour marker carbohydrate antigen 19‑9 (CA19‑9). Although the test's effectiveness had already been demonstrated in advanced pancreatic cancer, its value for detecting early‑stage disease had not previously been established.

To address this, Yamashita and colleagues set out to analyse ten patients with stage 0 to 1 pancreatic cancer – representing four per cent of 253 cases studied overall – and to compare them with 104 healthy individuals. Three diagnostic approaches were evaluated:

• • gene‑expression patterns in peripheral whole blood, measured as mRNA
  • the tumour marker CA19‑9
  • the combined Panregza test.

Using a panel of 56 gene probes, the gene‑expression approach alone detected nine out of the ten early‑stage cases. CA19‑9 alone detected only 10 per cent representing a substantial difference in performance between the two methods. The combined Panregza test achieved a sensitivity of 60 per cent and a specificity of 93.3 per cent.

"These findings indicate that gene expression analysis from peripheral whole blood is a highly effective method for detecting early-stage pancreatic cancer," said Yamashita.

At the Innovative Research and Development Center for Pancreatic Cancer, Kanazawa University Hospital, five‑year survival rates stand at 100 per cent for stage 0 disease and 74.4 per cent for stage 1 disease, a figure that underlines the critical importance of early diagnosis in improving prognosis.

Researchers at Kanazawa University have previously found that gene‑expression patterns in peripheral blood mononuclear cells – most of which are immune cells – differ between patients with pancreatic cancer and healthy individuals, on the basis that pancreatic cancer cells appear to alter immune cell gene expression. On the strength of this earlier finding, the team developed the Panregza diagnostic kit, using whole blood and CA19‑9 which is now marketed by Cubix Inc. It has remained unclear, however, whether such changes could also be detected in early‑stage disease, where the tumour burden is minimal.

This study has demonstrated that abnormalities in whole‑blood gene expression can be detected even in stage 0 to 1 pancreatic cancer, including in patients with normal CA19‑9 levels. This suggests that the diagnostic test enables early detection independent of tumour volume.

In response to the rising incidence of pancreatic cancer in recent years, Kanazawa University established the Innovative Research and Development Center for Pancreatic Cancer in April 2025, with the aim to develop novel diagnostic and therapeutic approaches.

The centre is led by Professor Shintaro Yagi of the Department of Hepato‑Biliary‑Pancreatic Surgery and Transplantation, and brings together specialists from the departments of gastroenterology, hepato‑biliary‑pancreatic surgery and transplantation, radiology, medical oncology and pathology to advance the diagnosis, treatment and research of pancreatic cancer.

For further reading please visit: 10.1038/s41598-026-58684-8