Panuri Performance Study

Evaluation of the Performance of Panuri - Test for Detection of Pancreatic Ductal Adenocarcinoma

The main purpose of the study is to assess the performance of the Panuri test in detecting pancreatic ductal adenocarcinoma (PDAC) the most common type of pancreatic cancer that accounts for approximately 90% of all pancreatic cancer cases.

The study aims to characterize the performance of the Panuri test in detecting pancreatic ductal adenocarcinoma in patients with symptoms supporting a clinical suspicion of pancreatic cancer The Panuri test is intended for professional laboratory use for diagnostic purposes.

This is a prospective, multi-site, enriched, observational, non-interventional clinical study to characterize the performance of Panuri for the detection of pancreatic ductal adenocarcinoma (PDAC) in symptomatic patients. The study is enriched for patients with pancreatic cancer.

Panuri is a qualitative, chromogenic, automated in vitro diagnostic assay designed to detect, in human urine samples, the proteolytic enzymes activity associated with pancreatic ductal adenocarcinoma. The Panuri test is indicated in adult patients with symptoms supporting a clinical suspicion of pancreatic cancer at initial presentation. The Panuri test is to be used in conjunction with the initial workup to help physicians evaluate whether further diagnostic imaging (e.g., CT/MRI) is required. All participants will have their reference standard diagnosis identified through review of electronic health records (EHR).

Participants and physicians will remain blinded to the results of Panuri testing.

Inclusion Criteria:

• Arm 1 (Target Arm):

  • Adults 18 years and older
  • Presenting with symptoms supporting a clinical suspicion for pancreatic cancer by the healthcare provider, including but not limited to jaundice, abdominal or back pain, fatty stools, unexplained weight loss, loss of appetite, chronic fatigue, nausea, vomiting, indigestion, bloating, gas, diarrhea, constipation, itching, dark urine, fever, and swelling of the legs.

• Arm 2 (Enriched Arm):

  • Adults 18 years and older
  • Scheduled for a procedure involving pancreatic histopathological assessment due to suspicion of pancreatic cancer.

Exclusion Criteria:

• For subjects in the enriched arm, imaging results are highly suspicious for non-PDAC pancreatic cancer.
• Patients enrolled in a pancreatic cancer screening program.
• Prior diagnosis of pancreas malignancy, including pathological diagnoses and suspicion of pancreatic cancer based on clinical, histopathological or radiological results. Exceptions include: pancreatic intraepithelial neoplasia (PanIN), intraductal papillary mucinous neoplasms (IPMN), mucinous cystadenoma of the pancreas (MCN), serous cystadenomas (SCN) or other benign pancreatic lesions and cystic lesions without features suggestive of malignancy.
• History of pancreatic resection
• Presenting with concurrent symptoms or suspicion of urinary tract infection Diagnosis of any urinary tract infection within the last 30 days, except for cases that have been resolved with antibiotics discontinued at least 14 days prior to enrollment
• Diagnosed with stage 3b to 5 chronic kidney diseases (CDK3b-CDK5), acute kidney disease in last 3 months, nephrotic syndrome in the last 6 months, or other kidney diseases associated with proteinuria
• Diagnosed with any conditions that increase bilirubin levels within the last 6 months
• Self-reported or documented elevated blood bilirubin levels within the past 3 months, defined as exceeding 1.5 times the upper limit of normal specific to the test laboratory
• Diagnosis of any cancer within the past 5 years
• Chemotherapy or anti-neoplastic therapy within the last 5 years
• Any medical or psychological conditions that preclude compliance with study procedures.
• Patients without any clinical signs or symptoms of pancreatic cancer
• Inability to provide written informed consent.
• Pregnant or breastfeeding women
• Current participation in another drug or device study or planned participation prior to completion of sample collection procedures (i.e., approximately 1.5 months)