Diagnostic Test

Diagnostic Test

The need

Early stage pancreatic cancer is a silent disease; it becomes apparent only after tumor invasion of surrounding tissues or metastatic seeding of distant organs. Suspected pancreatic ductal adenocarcinoma (PDAC) cases are primarily identified through imaging (e.g., ultrasonography, computed tomography and magnetic resonance).

This approach only identifies a pancreatic mass, which could be related to non-malignant pancreatic disorders, such us chronic pancreatitis (CP) or other benign pancreatic lesions. Definitive diagnosis is usually obtained through biopsies, which are invasive procedures and usually are accomplished by endoscopic ultrasonography. Thus, the definitive diagnosis of PDAC or pancreatic precursor lesions is almost impossible when using only non-invasive procedures.

Decreasing the pancreatic cancer mortality rate is a clear unmet medical need today.

Because of the lack of early symptoms, aggressive growth and early dissemination, 80% patients are diagnosed at late stages with advanced distant metastases, which make their disease surgically inoperable [8]. To improve prognosis and reduce the mortality, a cost-effective tool for early diagnosis of pancreatic cancer is needed.

As the result of the increasing use of abdominal imaging in standard medical practice and an aging population, pancreatic cysts (such as intraductal papillary mucinous neoplasm -IPMN- or mucinous cystic neoplasm –MCN-) are being identified with increasing frequency. These lesions pose a challenging life-long management problem that is becoming a major clinical problem [10].

Other problem for early diagnosis is the similar symptomatology with other pathologies such us chronic pancreatitis (CP). The unreliability of the available diagnostic tools has led to 10% of cases receiving unnecessary surgery after being erroneously classified as having pancreatic cancer [11].

The test

PancreaDix is an innovative non-invasive signature in blood for the detection of pancreatic ductal adenocarcinoma (PDAC) and pre-neoplasic lesions. It is a molecular test based on the expression quantification of microRNAs by RT-qPCR technique.

The test will improve the early detection of pre-malignant and malignant lesions and enable physicians a better management of patients with pancreatic cancer and other pancreatic pathologies.


Bibliography

  • 8. Lin et al. Metabonomic alterations from pancreatic intraepithelial neoplasia to pancreatic ductal adenocarcinoma facilitate the identification of biomarkers in serum for early diagnosis of pancreatic cancer. Mol. BioSyst. 2016, 12, 2883-2892.
  • 10. Wu et al. Whole-exome sequencing of neoplastic cysts of the pancreas reveals recurrent mutations in components of ubiquitin-dependent pathways. PNAS; 2011; 108,no. 52: 21188-21193.
  • 11. Ferri et al. Improved Pancreatic Adenocarcinoma Diagnosis in Jaundiced and Non-Jaundiced Pancreatic Adenocarcinoma Patients through the Combination of Routine Clinical Markers Associated to Pancreatic Adenocarcinoma Pathophysiology. PLoS ONE; 2016; 11(1): e0147214.

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