A simple blood test to support colorectal cancer assessment in symptomatic patients.
ColoSTAT® provides additional information to help guide next steps when bowel cancer symptoms are present.
Built on Australian CSIRO research and developed by Rhythm Biosciences for use in symptomatic colorectal cancer pathways.
In Australia, Bowel Cancer or Colorectal Cancer (CRC) is the fourth-most common cancer diagnosis and second leading cause of cancer death, with over 15,000 cases diagnosed each year. When detected early in stages I and II, it is well established that the 5-year survival rate for Colorectal cancer is greater than 90%.
Source: https://ncci.canceraustralia.gov.au/outcomes/relative-survival-rate/relative-survival-stage-diagnosis-colorectal-cancer
ColoSTAT® supports clinical decision-making between initial symptom presentation and referral for colonoscopy — helping guide next steps when the need for investigation is unclear.
A simple blood test for patients with symptoms
Symptoms can include: blood in stool, change in bowel habits (diarrhoea, constipation, frequency), abdominal pain, bloating, cramps, fatigue, anaemia, or weight loss.
Helps clinicians triage patients for prioritising colonoscopy
The vast majority of colonoscopies referred to investigate CRC return negative results. ColoSTAT® provides an additional tool to help clinicians prioritise high-risk individuals for immediate colonoscopy.
99.4% Negative Predictive Value
A ColoSTAT® Negative result means there is less than a 1% chance of colorectal cancer. This can help reassure patients, reduce anxiety, and support clinical management by the healthcare practitioner.*
In Australia only 13% of Colonoscopies are performed within the recommended 30 days
The median public hospital wait time is 84 days, and demand for referrals is expected to rise by 10% by 2030. ColoSTAT® could help reduce colonoscopies by 50% annually, easing system pressure and costs while helping prioritise patients who need urgent care most.
Clinically validated with 91% sensitivity across all stages of colorectal cancer
Many diagnostic tests perform well in late-stage disease but miss early cancers when they are most treatable. ColoSTAT® achieves 91% sensitivity in both early- and late-stage disease, meaning a ColoSTAT® Positive result is just as likely to reflect early, curable cancer as advanced disease.
ColoSTAT® does not replace bowel cancer screening or surveillance colonoscopy
ColoSTAT® is intended for use in patients with symptoms suggestive of CRC. Patients without symptoms are encouraged to participate in the National Bowel Cancer Screening Program, which is available to individuals aged 50 to 74 years.
*Clinical follow-up, based on best practice guidelines are still recommended for all low-risk ColoSTAT® results, especially for persistent symptoms.
Why triage matters?
Colonoscopy is the gold standard for diagnosing colorectal cancer, but in symptomatic patients, only a small proportion of referrals result in a cancer diagnosis. At the same time, demand for colonoscopy continues to increase, placing pressure on access and wait times.
ColoSTAT® provides additional information to support these decisions, helping clinicians prioritise patients who may benefit most from further investigation.
Symptoms present
Patients present to their GP with symptoms such as blood in stool, changes in bowel habits, abdominal pain, or unexplained weight loss.
Blood test ordered
ColoSTAT® can be requested alongside routine blood tests. No special preparation or stool sample is required.
Results returned
ColoSTAT® results are returned to the referring clinician within 4-10 days.
Informed next step
Based on the result, the clinician determines whether a colonoscopy referral is appropriate.
Find the right pathway
ColoSTAT® serves as another aid for clinicians making referral decisions for patients navigating CRC symptoms.
The information you need depends on which side of the consultation you’re on.
For Clinicians
Learn how ColoSTAT® supports colorectal cancer assessment in symptomatic patients and integrates into your clinical workflow.
Explore ColoSTAT® →
For Patients
Learn more →
THE SCIENCE BEHIND COLOSTAT®
Built on Australian CSIRO research and years of clinical development by Rhythm Biosciences.
ColoSTAT® is a blood-based test that detects protein biomarkers associated with colorectal cancer. Its performance has been evaluated in clinical studies across multiple patient populations, supporting its use in symptomatic pathways.
EVIDENCE SNAPSHOT
The clinical data behind ColoSTAT® is what sets it apart.
ColoSTAT® is backed by clinical validation across multiple patient populations.
91% early-stage sensitivity
ColoSTAT® detects 9 out of 10 colorectal cancers in symptomatic patients, including earlier-stage disease. This supports timely identification of patients who may need further investigation.
99.4% Negative Predictive Value
A ColoSTAT® Negative result is associated with a very low likelihood of colorectal cancer. This can support more confident decision-making when considering whether immediate colonoscopy referral is required.*
Validated across populations
Clinical performance has been evaluated across multiple patient cohorts, supporting confidence in its use across diverse clinical settings. This helps demonstrate consistency beyond a single study group.
Stage-by-stage sensitivity
ColoSTAT® demonstrated consistent sensitivity across all stages of CRC, with performance in Stage I/II disease equivalent to Stage III/IV disease. This means a ColoSTAT® Positive result is just as likely to reflect early, potentially curable cancer as advanced disease.
View clinical data →
Why sensitivity matters
Many tests perform better in later-stage disease, when cancer is already more advanced. ColoSTAT® helps support earlier identification by maintaining sensitivity in Stage I and II disease, when treatment is most likely to be curative.
See the evidence →
*Clinical follow-up, based on best practice guidelines are still recommended for all low-risk ColoSTAT® results, especially for persistent symptoms.
ColoSTAT® ACCESS PROGRAM
Be among the first clinicians to integrate ColoSTAT® into symptomatic pathways.
The ColoSTAT® Access Program provides early clinical access, supports independent decision-making, and support its use in real-world practice.
