FIRST PROGRAM

The indeterminate decision we are working on.

A blood-based aid to malignancy risk stratification for adults under evaluation for known or suspected tumour. Under development. Research use only.

THE DECISION

Imaging identifies the lesion. It does not always resolve the diagnosis.

When cross-sectional imaging remains indeterminate, the clinician still has to choose among surveillance, endoscopic ultrasound with tissue acquisition, and surgery. The recurring situations include an indeterminate solid lesion, unexplained duct dilation, a cyst with equivocal features, or chronic pancreatitis with concern for occult malignancy.

CA19-9 leaves real uncertainty in exactly these settings. It is elevated by benign biliary obstruction and uninformative in the 5–10% of patients who are Lewis-antigen negative.

Zhao et al., Eur J Gastroenterol Hepatol 2022; Luo et al., Pancreatology 2018.

INTENDED ROLE

One additional input, at the point where imaging has run out of answers.

Open-access CT example: a 2 × 2 cm indeterminate pancreatic tail lesion.
Indeterminate imaging
→Peripheral blood sample for molecular analysis.
Blood draw
→Multimodal signals converge into a risk estimate.
Risk stratification
→Additional evidence supports the next clinical decision.
Escalate or continue surveillance

Source: El Imad et al., Cureus 2017, CC BY

Populations under consideration

Chronic pancreatitis · IPMN and pancreatic cystic lesions under surveillance · Indeterminate solid pancreatic lesions · Isolated pancreatic ductal abnormalities · Benign biliary obstruction

STATUS

Where the program stands today.

  • Computational proof of concept complete and published as a preprint.
  • Assay development underway.
  • Assay chemistry, feature set, and decision threshold are not yet locked.
  • A prospective clinical study is in design, and we are seeking academic clinical and specimen partners.

COLLABORATE

We welcome collaborations with clinicians, researchers, and industry partners.

We are building the study, assay, and clinical workflow with partners who work directly with molecular data, and cancer diagnostics.

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