ColoSTAT® is an in vitro diagnostic (IVD) product that adheres to the requirements of the IVD Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. ColoSTAT® is approved for sale in Europe.
It is well established that the 5-year survival rate for CRC, is greater than 90% when detected early2
Missed detection of early-stage CRC results in poor survival rates3-5
Stage I - II
91%
Stage III
72%
Stage IV
13%
Risk factors associated with CRC
A risk factor is any factor that may increase a person’s possibility of developing cancer. Some risk factors are referred to as modifiable, such as lifestyle or environmental risk factors. Others are called non-modifiable, such as inherited factors or whether someone in the family has had cancer.6
The cause of colorectal cancer is not known. Evaluating your risk factors and discussing them with the doctor may help you make more informed lifestyle and health care choices.6
Modifiable Risk Factors6
A diet low in fibre
High red meat consumption, especially processed meats
Physical inactivity and obesity
Consumption of alcohol and tobacco
Low blood level of vitamin D
Non-Modifiable Risk Factors6
Personal history of certain types of cancers (ovarian/uterine)
IBD, such as Crohn’s and Ulcerative Colitis
Family history of CRC
Type 2 Diabetes
Aged ≥ 50
A previous diagnosis of polyps/CRC
Participation in CRC screening remains suboptimal despite national programs being in place in many countries worldwide.
In Australia, over 50% of eligible individuals remain unscreened for CRC, and this has not changed since the national program was introduced in 2006.7
Observational studies have shown that 78-93% of people offered CRC screening, preferred blood-based tests over faecal tests, with ease and convenience being the main reason for their preference.2,8
Reasons for preferring blood-based options:2,8
- Convenience of a blood draw
- Ease / comfort of a blood test
- Lower time requirement vs faecal test
Rhythm Biosciences has developed ColoSTAT®*, a simple, affordable blood-based test for the detection of CRC
ColoSTAT® is indicated to screen adults, aged 40 to 85, at average risk for developing CRC. The test-kit measures five specific biomarkers in the blood that either increase or decrease in quantity when CRC tumours are present.
Generated data, along with the individual's age and sex, are entered into the ColoSTAT® proprietary algorithm software to produce a CRC ‘likelihood score’.
*currently not approved for use in Australia
1
Standard blood draw at laboratory
/ collection centre (with referral)
2
Blood sample analysed at laboratory
3
Result sent to GP
4
GP follow-up with patient
SIMPLE – A blood test that is an easy addition to the standard panel of doctor requests. It is designed for easy adaptation by laboratories performing ELISA assays routinely.
ACCURATE – obtains a qualitative likelihood of CRC presence based on 5 protein biomarker levels in the blood.
PATIENT-FRIENDLY – convenient and can be part of routine health control.
ColoSTAT® has the potential to:
-
Provide an alternative for those unwilling or unable to participate in current screening programs
-
Increase participation rate in CRC testing
-
Improve early diagnosis of CRC
-
Improve survival rates
-
Reduce mortality rate
-
Reduce healthcare costs associated with CRC treatment
ColoSTAT® immunoassay test does not diagnose colorectal cancer but is a tool for determining when colonoscopy or another type of diagnostic follow-up is recommended.
RHY-001 study,9 validates ColoSTAT® as a high-sensitivity blood test for CRC detection showing: a sensitivity of 81.3% (overall CRC) and specificity of 91%
Sensitivity9
81.3%
Specificity9
91%
Certification
CE mark
UKCA mark
The ColoSTAT® colorectal cancer detection product is granted UKCA (UK Conformity Assessment) mark, fully conforming with the European directives for IVD Medical Devices (98/79/EC) and the UKCA requirement.
Medsafe
Medsafe is the New Zealand Medicine and Medical Devices Safety Authority, which is a business unit of the Ministry of Health and is the authority responsible for the regulation of therapeutic products into the country. As a manufacturer of ColoSTAT®, Rhythm has registered with Medsafe and listed ColoSTAT® to its Web Assisted Notification of Devices (WAND) database.
References
- https://www.cancer.net/cancer-types/colorectal-cancer/risk-factors-and-prevention#:~:text=About%2011%25%20of%20all%20colorectal,cancer%20in%20the%20United%20States
- Adler A, Geiger S, Keil A, Bias H, Schatz P, deVos T, et al. Improving compliance to colorectal cancer screening using blood and stool based tests in patients refusing screening colonoscopy in Germany. BMC Gastroenterol. 2014 Oct 17;14:183
- Australia colorectal cancer statistics. Available at: https://ncci.canceraustralia.gov.au/diagnosis/distribution-cancer-stage/distribution-cancer-stage
- UK colorectal cancer statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bowel-cancer/survival#heading-Three
- US colorectal cancer statistics. Available at : https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html
- https://www.canceraustralia.gov.au/cancer-types/bowel-cancer/awareness
- National Cancer Control Indicators - https://ncci.canceraustralia.gov.au/screening/colorectal-screening-rates/colorectal-screening-rate-participation
- Liles EG, Coronado GD, Perrin N, Harte AH, Nungesser R, Quigley N, Potter NT, Weiss G, Koenig T, deVos T. screening blood test is higher than of a fecal test offered in clinic: A randomized trial. Cancer Treatment and Research Communications. 2017 10: 27-31
- Data on file, October 2021
About us:
Copyright | Rhythm Biosciences - ABN 59 619 459 335
Contact
Rhythm Biosciences
Bio21 Institute
30 Flemington Road
Parkville VIC 3010
Australia
