ColoAlert Colorectal Cancer Screening

On diagnosis of colorectal cancer the most common treatment options involve:

• 66 % surgical resection for colorectal cancer
• 33 % radiotherapy for rectal cancer
• 31 % chemotherapy for colorectal cancer
• 3 % radiotherapy for colon cancer

The purpose of colorectal cancer screening is to detect and treat the disease as early as possible, since survival rates significantly drop with a later stage diagnosis.

Currently the following screening options are available:

1. NHS “Two-week“ urgent GP referral to a specialist for suspected colorectal cancer.
2. NHS colorectal cancer screening programme: Bowel Scope (Age: 55-59 yrs – Frequency: One-off) This screening tool is also known as colonoscopy. A physician uses a small camera inserted in the rectum to look for abnormal growth inside the bowel. This is considered the gold standard but invasive, inconvenient and requires dietary and bowel preparations. Currently, this option is subject to limited geographical availability. NHS Faecal Immunochemical test (FIT) for patients aged 60+ yrs – frequency: every 2 years FIT, also often called blood-in-stool test, is a non- invasive screening test that will detect blood from the lower bowel in the stools, which may indicate colorectal cancer. However, blood in the stool may also be caused by other health conditions such as inflammation, ulcers, Inflammatory Bowel Diseases (such as Crohn’s disease or ulcerative colitis) or haemorrhoids. Furthermore, not all colorectal polyps, especially in early stages and right-sided ones, will bleed permanently or at all.
3. ColoAlert® stool DNA test for patients aged 45+ yrs – frequency: every 3 years. Currently not available on the NHS, but accessible privately. ColoAlert® is a non-invasive and highly sensitive stool DNA test for the early detection of colorectal cancer. It specifically screens for mutations in bowel cell DNA, that indicate cancer growth rather than an undefined source of blood alone. In addition, the ColoAlert® kit quantifies the amount of human DNA and haemoglobin for a more comprehensive screening profile.

Colorectal cancer most often results in death if left untreated or diagnosed late. It is the second-largest cause of cancer mortality in the UK with 16,300 deaths per year, accounting for 10 % of all cancer deaths in the UK, which equates to 45 deaths per day (2015-2017).

The Dukes Staging system differentiates between four cancer stages and is based on the degree of spread of colorectal cancer. Each stage corresponds
to a decreasing 5-year-survival-rate:

However, a significant proportion of cases (61 %) diagnosed at stages II, III and IV already report spread of the cancer outside the bowels. In recent years, there has been a dramatic rise in new colorectal cancer cases per year, especially in younger age groups (ages 30: 6.8 % rise/year; under 50s: 1.8 % rise/year).

In England, survival is higher for patients diagnosed aged 15 - 39 and those diagnosed aged 60 - 69, irrespective of stage.

Undertaking colorectal cancer screening is therefore critical for the early detection and prevention, and in turn higher chances of cure and survival.

Screening can be done within the NHS from 55-59 with colonoscopy and from 60 years onwards with FIT tests. However for tumour DNA tests such as ColoAlert®, many experts including the US Food and Drug Administration (FDA) recommend to start from 45 onwards, thus allowing for an earlier detection with increased survival rates.

Anyone who wishes to be screened for colorectal cancer without an invasive procedure can use ColoAlert.

Recommended from the age of 45: Aging can increase the error rate of the replication process of genetic material in cells. This can give rise to mutant DNA, which promotes the development of colorectal cancer. Recent scientific evidence advises for screening to start at the age of 40.

People with the following risk factors:
• High body mass index (BMI)
• Diet high in red/processed meat, fat and/or
sugar
• Smoking
• Alcohol consumption
• Diabetes mellitus Type 2

Exceptions:
Patients with a family history of colorectal cancer should be referred to a geneticist. In the event close family relatives (parents, siblings) have developed colorectal cancer under the age of 50, there is an increased risk of other family members developing the condition deriving from hereditary genes not tested with ColoAlert®.

The CE-IVD-certified ColoAlert® kit contains everything you need to collect a sample at home in just 5 minutes. The stool samples are processed by our accredited laboratory.

The ColoAlert® patient kit includes stool sample collectors for:

• Stool DNA testing for KRAS/BRAF markers and the quantification of human DNA
• Faecal immunochemical testing (FIT)

1a) See your private GP for an initial consultation about your symptoms. Your GP will inform you about your possible screening options with respect to your symptoms and provide you with the ColoAlert® patient kit to take home.

1b) ColoAlert® patient kits are also available on the ColoAlert® website in our online store. Please consult our website for an up-to-date list of Colo-
Alert® retailers on www.bioxmedical.co.uk

2) Please carefully follow the instructions in the ColoAlert® patient kit provided to you to collect the two required stool samples.

3) Once your samples are collected and appropriately labeled, please follow the provided postal instructions.

4) Important information: the samples need to be sent latest the next day after sample collection in order to arrive at our specified lab within max. 96 hours. Weekend mail is to be avoided due to possible delays in shipping times during non-working days.

5) Laboratory Processing Time: Once your two samples have arrived safely at our specified laboratory, the processing and analysis time for the two samples are 5 days for ColoAlert® Plus and 9 days for ColoAlert® Basic.