What is or why multi cancer early detection (MCED)?
Detecting most cancers early, results in less deaths and less severe treatment for patients. In turn, early detection of cancer therefore improves quality of life and reduces the costs associated with cancer care. Current detection tests are single cancer tests (e.g FIT for colorectal cancer). With MCED an individual is tested for multiple cancers using one test. OncoSeek® is a MCED test that is based on a sample of blood, which makes it easy to test. This is not always the case for single cancer tests.
Which cancers can OncoSeek® detect?
OncoSeek® has been validated to detect breast, colorectal, esophagus, liver, lung, lymphoma, ovary, pancreatic and stomach cancer. These cancers were chosen because they are high impact cancers. Development is ongoing to expand the set of cancers.
How has OncoSeek® been validated?
OncoSeek® has been validated using data of approximately 15,000 individuals.
What is the OncoSeek® test procedure?
For OncoSeek® a tube of 8 ml blood is drawn. This tube is transported to a selected laboratory were the blood is analysed for a selected number of protein tumor markers. The values of these markers together with age and gender are input for the OncoSeek® algorithm. This algorithm calculates the probability of cancer on a scale from 0 to 1; scores below 0.5 are considered low risk, while a score between 0.5 and 0.9 is medium risk and above 0.9 is high risk. The OncoSeek® report is sent by email or other means to the ordering physician. The physician will contact the patient to discuss the result of the OncoSeek® test.
OncoSeek® has an accuracy of 84.3% in validation cohorts, what does it mean?
The accuracy is calculated based on the results of the validation cohorts. The formula for accuracy is the sum of all true positives and true negatives divided by the total population size.
Protein tumor markers are already used for cancer detection. What is the benefit of using OncoSeek®?
The OncoSeek® algorithm analyses the specific relations between markers and clinical factors, drastically reducing false positives when compared to the standard analysis of multiple, individually judged, protein tumour markers. This algorithm is unique and makes it possible to effectively use this panel of a selected number of markers for multi cancer early detection.
OncoSeek® has a sensitivity of 51% and specificity of 93%, what does it mean?
Sensitivity is number of people with a positive test result (Probability of Cancer score > 0,5) divided by the actual number of persons with cancer. In a population where there are 1959 persons with a cancer 1012 persons tested positive for cancer based on OncoSeek®. The sensitivity is calculated as 1012 divided by 1959 which equals 51.7%.
Specificity is the number of tested negatives (Probability of Cancer score < 0,5) divided by the actual number of persons in the population without cancer. In this example 6896 persons received a OncoSeek® result that indicated no cancer, while in the total population 7423 persons did not have a cancer. Specificity is 6896 divided by 7423, which equals 92.9%.
What your result means for you as a patient, is subject to medical interpretation and will depend on your personal risk factors and medical situation.
OncoSeek® provides a probability of cancer score. How should the results be interpreted?
OncoSeek® will identify risk for cancer – it will NOT diagnose cancer. OncoSeek® aims to reduce the time till cancer diagnosis by early detection and removing barriers to detection.
OncoSeek® results may be compared to taking the temperature. A temperature between 36-37 degrees Celsius or 97-99F is considered normal. A slightly lower or higher temperature can indicate (upcoming) illness but can also be caused by other factors, e.g. food, exercise. Moreover, not everybody’s normal temperature is the same. Temperatures that are significantly higher than this warning range indicate a high probability of illness, but not always. A physician will always consider other factors and information when discussing the results and possible follow-up with you.
What's the follow-up to a medium risk or high risk test result?
A Probability of Cancer score between 0.5 and 0.9 is medium risk. A medium risk result is foremost a signal to monitor. It can be indication of something going on, but the signal is not very clear. In this case your physician will take other factors into account, like e.g. do you have symptoms, what is your medical history, to determine follow-up. In case there is no clinical reason for immediate diagnostic follow-up we recommend retaking the test in one month time. If results remain the same (+/- 10%) there is no reason for further diagnostic follow-up, unless your physician judges otherwise based on other inputs. We do recommend retaking OncoSeek® on a 6 months basis to monitor.
A probability of Cancer score higher than 0.9 is high risk. In case of a high risk result, further diagnostic follow-up, e.g. scan or echo is required to diagnose the cancer. In case of a high risk result, the OncoSeek® test will provide an indication of tissue of origin to guide the diagnostic follow up.
Where does OncoSeek® fit in the healthcare system?
OncoSeek® is a screening tool for high-risk groups of people, and may be used as a clinical tool in community and/or primary care to accelerate the path towards diagnosis. Depending on the local context the best way to use OncoSeek® has to be defined. OncoInv has resources that can advise and help in fitting OncoSeek® in the local health care systems.
Where can I get OncoSeek®?
OncoSeek® is made available through local distributors. OncoInv does not sell OncoSeek® directly to individuals or medical organisations. By using local resellers OncoInv ensures that the OncoSeek® product is offered in accordance with local medical procedures and regulations.
Here you can find our current resellers.
If you are interested in becoming a reseller, please contact us.
Is OncoSeek® sold directly to individuals?
No, OncoSeek® always made available through medical care professionals to ensure adequate interpretation of the results and follow-up in case the result is medium or high risk of cancer.
OncoInv is a social enterprise, what does it men?
It’s is the mission of OncoInv to make Multi Cancer Early Detection available globally and especially in Low and Middle Income countries (LMIC’s) where the need for early detection is high. OncoInv offers OncoSeek® on a not-for-profit basis in LMIC’s; pricing is based on the World Bank categorisation of a country. OncoInv is subsidiary of the Inspire2Live patient advocacy foundation, which has a majority stake in OncoInv. All other investors are impact-driven.
What analysis platform is needed?
Lab analysis on Roche Cobas, Abbott, GBI or Bio-Rad. Analysis with off-the-shelf reagents, widely available globally.
Blood is analysed using the Roche Cobas Electrochemiluminescence (ECL)-platform or similar.
What assay is required?
For the analysis of the PTM markers regular off the shelf assays offered for these markers by the platform vendor can be used. No test specific assay is needed for OncoSeek®.
How good and accurate is the test?
The OncoSeek® test has a sensitivity of 51.7% and a specificity of 92.9%. Sensitivity tells you the ability to detect correctly people who have cancer, and specificity tell the ability to detect correctly that people do not have cancer. In the case of false positive this will probably become clear in the follow-up to the positive test result, because 6 out of 7 false positives are a medium risk, which warrants a follow up test one month later to confirm. OncoSeek® outperforms the conventional clinical method of cancer detection.