Frequently Asked Questions
Frequently Asked Questions
Detecting cancer earlier may reduce mortality and treatment burden for patients. Earlier detection may improve quality of life and help reduce the costs associated with cancer care. Current detection tests are often focused on a single cancer type (for example, FIT testing for colorectal cancer). With MCD, an individual can be tested for multiple cancers using a single test.
OncoSeek® is an MCD blood test, making it relatively easy to administer compared with some single-cancer detection tests.
OncoSeek® has been validated to detect breast, colorectal, oesophageal, liver, lung, lymphoma, ovarian, pancreatic, and stomach cancer. These cancers were selected because they are high-impact cancers. Development is ongoing to expand the number of cancers included.
OncoSeek® has been validated using data from approximately 15,122 study participants.
For OncoSeek®, a tube of 8 mL blood is collected. The sample is transported to a selected laboratory where the blood is analysed for a selected number of protein tumor markers. The values of these markers, together with age and sex, are used as input for the OncoSeek® algorithm.
The algorithm calculates a Probability of Cancer score on a scale from 0 to 1:
- Scores below 0.5 are considered Low Probability
- Scores between 0.5 and 0.9 are considered Medium Probability
- Scores above 0.9 are considered High Probability
The OncoSeek® report is sent by email or other means to the ordering physician. The physician will discuss the OncoSeek® result with the patient.
Accuracy is calculated based on the results of the validation cohorts. The formula for accuracy is the total number of true positives and true negatives divided by the total population size.
The OncoSeek® algorithm analyses the relationships between markers and clinical factors, helping reduce false positives compared with conventional analysis of multiple individually interpreted protein tumor markers.
This proprietary algorithm makes it possible to effectively use this selected panel of markers for multi-cancer detection.
Sensitivity is the number of people with a positive test result (Probability of Cancer score >0.5) divided by the actual number of people with cancer.
In a population containing 3,029 people with cancer, 1,768 individuals tested positive for cancer based on OncoSeek®. Sensitivity is therefore calculated as 1,768 divided by 3,029, which equals 58.4%.
Specificity is the number of people with a negative test result (Probability of Cancer score <0.5) divided by the actual number of people without cancer.
In this example, 11,127 individuals received an OncoSeek® result indicating no cancer, while 12,093 individuals in the total population did not have cancer. Specificity is therefore calculated as 11,127 divided by 12,093, which equals 92.0%.
What your result means for you as a patient requires medical interpretation and depends on your personal risk factors and medical situation.
OncoSeek® identifies risk for cancer. It does not diagnose cancer. OncoSeek® aims to support earlier cancer detection and help reduce barriers to detection.
OncoSeek® results may be compared to taking a temperature. A temperature between 36–37°C or 97–99°F is generally considered normal. Slightly lower or higher temperatures may indicate illness, but can also be influenced by other factors such as food or exercise. In addition, normal body temperature differs between individuals. Temperatures significantly above this range may indicate a higher probability of illness, but not always. Physicians will always consider additional clinical information and patient-specific factors when discussing results and possible follow-up.
A Probability of Cancer score between 0.5 and 0.9 is considered Medium Probability. A Medium Probability result is primarily a signal for reassessment. It may indicate that something is occurring, but the signal is not definitive.
In this situation, the physician will consider additional factors, such as symptoms and medical history, to determine appropriate follow-up. If there is no clinical reason for immediate diagnostic follow-up, we recommend repeating the test after one month. If the results remain stable (+/-10%), additional diagnostic follow-up may not be necessary unless otherwise determined by the physician.
We do recommend repeating OncoSeek® every 6 months for reassessment.
A Probability of Cancer score above 0.9 is considered High Probability. In the case of a High Probability result, further diagnostic follow-up, such as a scan or echo, is required to diagnose cancer.
In cases of High Probability, the OncoSeek® test also provides an indication of Tissue of Origin to help guide diagnostic follow-up.
OncoSeek® is a screening tool for high-risk groups and may also be used as a clinical tool in community and primary care settings to help accelerate the path toward diagnosis.
Depending on the local context, the most appropriate use of OncoSeek® should be determined locally. OncoInv can provide guidance on implementation within local healthcare settings.
OncoSeek® is made available through local distributors. OncoInv does not sell OncoSeek® directly to individuals or medical organisations.
By working with local resellers, OncoInv aims to ensure that OncoSeek® 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.
No. OncoSeek® is always made available through healthcare professionals to help ensure appropriate interpretation of results and follow-up in cases of Medium or High Probability.
OncoInv’s mission is to make multi-cancer detection available globally, particularly in Low- and Middle-Income Countries (LMICs), where the need for earlier cancer detection is high.
OncoInv offers OncoSeek® on a not-for-profit basis in LMICs. Pricing is based on World Bank country classifications.
OncoInv is currently an entity of the Inspire2Live Foundation. Other investors are impact-driven.
Laboratory analysis can be performed on Roche Cobas, Abbott, GBI, BIO-Rad, or equivalent platforms using off-the-shelf reagents that are widely available globally.
Blood samples are analysed using the Roche Cobas Electrochemiluminescence (ECL) platform or equivalent systems.
For analysis of the Protein Tumour Markers (PTMs), standard off-the-shelf assays offered by the platform vendor can be used. No test-specific assay is required for OncoSeek®.
The OncoSeek® test has a sensitivity of 58.4% and a specificity of 92.0%.
Sensitivity describes the ability to correctly identify people who have cancer, while specificity describes the ability to correctly identify people who do not have cancer.
In cases of false positive results, this may become clearer during follow-up after a positive test result, because six out of seven false positive results are Medium Probability, which warrants repeat testing after one month for confirmation.