Antegenes^® Colorectal

• It analyses 91 genetic variants associated with colorectal cancer.

A personalised results report will be sent to the customer and made available to their clinician* (upon the customers consent)**.

There are two possible result outcomes from this test:

1. A lower risk test result
2. An increased risk test result

Every person taking the test will be sent a clinical support video explaining what their test results mean and the next steps to take.

In the case of an increased risk result, guidance is provided on what the customer should do next. This may include talking to their clinician about earlier screening options to help reduce the risk of developing colorectal cancer or seeking treatment earlier to help prevent mortality from the disease.

The results report will include the following:

1. Polygenic risk score: A score derived from thousands of genetic variants.
2. Personal risk: This shows an individual’s personal risk of developing the cancer tested for over the next 10 years, compared to someone of their age in the general population.
3. General population comparison: A number showing the average risk that someone of similar age and nationality has of developing the cancer tested for.
4. Relative risk: A number which compares your risk to that of the general population.

No personal medical guidance is provided in the test results report. This should be obtained from the customer’s clinician.

*Results reports are only sent to the customers clinician when a test is organised through a GP/clinic/hospital.
**No results information is shared with an employer or insurance provider.

Who can order this test from Everything Genetic? Healthcare providers, employers and individuals.

Turnaround time: 4 weeks from the receipt of a sample in our laboratory.

Preferred specimen: Non-invasive simple saliva sample using Oragene OG-610.

Alternative specimen collection: None.

Delivery information: Test kits will be sent out by using a Royal Mail Tracked service, unless otherwise arranged.

Pre and post-test clinical support is a mandatory requirement for all customers taking the test.

Pre-test support is provided through a clinically guided informational video which explains:

• What the test is for
• Why customers should take the test
• What it does and doesn’t test for
• What the possible results are from taking the test

Following the test, customers will be provided a further clinically guided information video, depending on their level of risk.

In the case of an increased risk result, guidance is provided on what the customer should do next. This may include talking to their clinician about earlier screening options to help reduce the risk of developing colorectal cancer or seeking treatment earlier to prevent mortality.

For both pre and post-test clinical support, the customer has the option to arrange a telephone call with our Medical Director, Dr James Mackay.

Colorectal cancer is the third most diagnosed cancer, and can be caused by pathogenic variants in MLH1, MSH2, MSH6, PMS2 and EPCAM. Antegenes^® Colorectal is used to determine the carrier status of genetic variants that affect an individual’s risk, and then combined into a polygenic risk score to give a 10-year probability of developing the disease.

Individual customer risk is compared to the risk of someone the same sex and age in the normal UK population.

Antegenes^® Colorectal is a registered CE-marked medical device (IVD) developed by the Antegenes Medical Laboratory.

Limitations:

• Antegenes^® Colorectal is not used as a diagnostic tool for colorectal cancer.
• An increased risk estimated by the test does not mean that an individual will develop colorectal cancer during their lifetime. Nor does a lower risk mean that the probability of developing the disease is zero.
• Antegenes® Colorectal does not assess the risk of family and relatives, i.e., polygenic risk score-based disease risks may not be transmitted directly from parents to children.
• The test does not analyse rare pathogenic mutations in genes that significantly increase the risk of colorectal cancer, such as APC, KRAS, TP53, MLH1, MSH2, MSH6, PMS2, STK11, MUTYH and others.
• Different polygenic risk scores predicting risks of the same trait may provide different estimates. This is due to differences in genetic variants included in the models and their weights.
• The results of this test should be applied in context with other relevant clinical data, as well as other risk factors.

Validations and papers

View all validation documents and papers for this genetic test here >>