ColoSTAT — Clinical Information for Ordering Practitioners
Intended purpose
ColoSTAT is intended as an aid to clinical decision-making in patients presenting with symptoms that may be associated with colorectal cancer. It is designed to help inform decisions about further investigation, such as referral for colonoscopy.
ColoSTAT is not a diagnostic test, and a result must be interpreted by a qualified practitioner in the context of the patient's full clinical picture.
When you might consider it ColoSTAT may have a role where:
- A patient presents with symptoms potentially associated with colorectal cancer and you are weighing the need for further investigation
- A faecal immunochemical test (FIT) is unsuitable, or the patient is unable or unwilling to complete one
- Additional information may assist a referral decision where access to colonoscopy is constrained
It is intended to complement existing diagnostic pathways, not to substitute for them.
What ColoSTAT is not
- It is not a population screening test and is not intended for asymptomatic individuals. Asymptomatic, eligible patients should be directed to the National Bowel Cancer Screening Program.
- It does not replace colonoscopy where one is clinically indicated.
- A negative result does not exclude colorectal cancer or other pathology, and clinical judgement should prevail where symptoms persist.
- It is not a test for inflammatory, benign, or non-colorectal gastrointestinal conditions.
Reported clinical performance Performance figures below are drawn from the manufacturer's validation data and should be read together, including the limitations. Confirm current figures against the manufacturer's instructions for use before relying on them clinically.
- Reported sensitivity of approximately 91% for colorectal cancer
- Reported negative predictive value of approximately 99.4%
- Reported sensitivity of approximately 58% for advanced adenomas — clinicians should note materially lower sensitivity for pre-cancerous advanced adenomas than for established CRC
- Reported to be broadly comparable to faecal immunochemical testing in symptomatic populations
These figures relate to defined study populations and may not generalise to all patients. ColoSTAT is not represented as infallible, and no test result should be treated as conclusive in isolation.
Regulatory status ColoSTAT is supplied as a laboratory-developed test and is not represented as TGA-registered on the Australian Register of Therapeutic Goods. This information is provided so you can exercise informed clinical and professional judgement when ordering and when discussing the test with your patient.
Test instructions
We'll email you your pathology request form. Note this blood test is only available at 4Cyte Pathology collection centres.
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