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55129 Mainz
Germany

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Frequently Asked Questions

General information

What is ColoAlert?

ColoAlert is a non-invasive combination test used in colorectal cancer screening that detects mutated DNA from tumour cells as well as potentially abnormal levels of human DNA and occult blood in stool samples.

What is the difference between ColoAlert and the occult blood test (FIT)?

With ColoAlert, alongside the detection of occult blood, molecular genetic tests are performed in the laboratory to determine whether there is tumour DNA or potentially abnormal levels of human DNA in the stool. These additional tests increase the detection rate of colorectal cancer, the so-called sensitivity (proportion of positive test results in patients).

Why do you use stool instead of blood samples?

Since every person's intestinal wall cells are released into the stool, tumour cells also enter the stool in people affected by colorectal cancer. Therefore, cancer or its preliminary stages can usually be detected in the stool at an early stage. In contrast, tumour DNA can only be detected in the blood once the cancer has spread. By then it is usually too late for a full recovery.

Furthermore, a stool sample can also be taken at home by the patient, whereas sufficiently large blood samples are only taken by doctors.

My test result was positive - do I have to undergo a colonoscopy now?

In case of a positive test result, which is only applicable to a small percentage of all people tested, a doctor's visit is strongly recommended: In this case, the disease (or its precursors) can be confirmed by colonoscopy and, in many cases, abnormal tissue can be removed immediately without complicated medical intervention. Your doctor will discuss possible further procedures with you.

Who belongs to the target group for ColoAlert?

Colorectal cancer screening is generally recommended for all people over the age of 50, as the incidence rate of new cases in the population rises rapidly from this age​.1 In cases of familial predisposition, many experts recommend screening from the age of 40.

Since 90% of all colorectal cancers grow over a time period of 10 to 15 years2 and ColoAlert detects the first mutated tumour cells at an early stage, ColoAlert can also be started at the age of 40 to further increase safety.

ColoAlert - like all stool tests - is not suitable for patients suffering from intestinal diseases, especially chronic inflammatory disorders including Crohn's disease and ulcerative colitis.

 

1) Deutsche Krebsgesellschaft, Deutsche Krebshilfe, AWMF (2019). Leitlinienprogramm Onkologie, Langversion 2.0. AWMF Registrierungsnummer: 021/0070L. [https://www.leitlinienprogramm-onkologie.de/leitlinien/kolorektales-karzinom/, Stand: 23.01.2020] 2) Felix Burda Stiftung (o.J.). [ https://www.felix-burda-stiftung.de/darmkrebsvorsorge/was-ist-darmkrebs]

What is included in the ColoAlert patient kit?

Our ColoAlert complete kit contains the examination order, test instructions and a guide to colorectal cancer screening, as well as a stool collection aid and two stool sample collection tubes.

The packaging of the complete kit with the enclosed pressure seal bag also serves to return your samples to the laboratory and is already prepaid and addressed.

Which advantages does ColoAlert Plus offer?

ColoAlert Plus, as a premium variant, offers the advantage of an additional examination of your stool sample for the haemoglobin-haptoglobin complex. This complex is more stable during digestion than the regularly tested unbound haemoglobin. This makes occult blood detection even more sensitive.

In addition, you will receive your test result no later than five working days after our receipt of the sample. If you wish, we will also send you the test result via encrypted e-mail. This means that you will receive it on average a whole week earlier compared to ColoAlert Basic patients.

Do health insurance companies reimburse ColoAlert?

Genetic testing - like many other innovative developments - is not yet covered by all health insurance companies. If you are unsure, please contact your health insurance provider in advance to discuss the possibility of reimbursement.

Testing Procedure

Which advantages does your genetic test offer?

Compared to the detection of blood (components) such as occult blood (FIT) or the hemoglobin-haptoglobin complex (HbHp), the detection of tumour DNA is direct. This distinguishes ColoAlert from other methods such as the detection of M2-PK and calprotectin, which can also indirectly indicate the presence of a tumour.

Direct detection, as is the case with the detection of tumour DNA, is also generally possible from the first mutation of a healthy cell into a cancer cell - occult blood or its components, however, are only present when polyps or adenomas are large enough to bleed through friction.

Thereby, ColoAlert can identify considerably more affected individuals, especially in the earlier phases, without producing too many false-positive results ("specificity"). This improves their chances of recovery.

How can DNA be extracted from a stool sample?

In every human - whether healthy or ill - intestinal wall cells are constantly shed into the stool by friction. In people affected by colorectal cancer, tumour cells also enter the stool as a result.

In a first step, all DNA is now extracted from the stool in the laboratory. Human DNA is then separated from DNA from other sources for precise analysis. This originates from food and intestinal bacteria, among other things, and makes up the largest part of excreted DNA, which requires highly precise laboratory methods in order to be detected. The total amount of human DNA is then determined ("quantified") before it is finally examined for the tumour genes KRAS and BRAF, which are relevant for the development of colorectal cancer.

How reliable is the test result?

All testing methods have a certain error rate. In diagnostics, the error rate is represented by a test's sensitivity (share of correct-positive results) and specificity (share of correct-negative results). In colloquial language one could speak of "recognition rate" and "false alarm rate" (as the reverse of specificity).

The sensitivity of ColoAlert lies at 85 % according to an independent clinical study by the university hospitals in Leipzig and Halle-Wittenberg. The specificity amounts to 92 % - which means that false alarms occur in about 8 % of healthy patients. ColoAlert was thus able to achieve a noticeably better combination of sensitivity and specificity in the study than the testing procedures for occult blood and M2-PK, which were also reviewed.1

 

1) Dollinger MM et al. (2018), ClinLab 64(10), 1719-1730.

How often should ColoAlert be performed?

ColoAlert should be used at three-year intervals, as recommended by the US Food and Drug Administration (FDA) for a similar test from the USA. This is one of the advantages over other stool tests, which usually have to be repeated annually or biannually.

Since colorectal cancer grows over a period of 10 to 15 years in 90% of cases, this three-year interval offers at least three measurement points if screening is started early enough. This again significantly improves the cumulative detection rate.

Are there any side effects associated with ColoAlert?

As a non-invasive stool test, there are no side effects associated with ColoAlert when used properly.

Process

Which preparations are necessary for the implementation of ColoAlert?

None - unlike older stool tests, you do not need to change your diet or the intake of medication or dietary supplements before using ColoAlert.

Furthermore, your ColoAlert Patient Kit contains everything you need: test instructions, a topic guide, the obligatory examination order, a stool collection aid and the sample collection containers.

The transport of the samples to our laboratory is also already arranged for you: The packaging of the patient kit together with the enclosed pressure seal bag serves as a shipping box and is already prepaid and addressed.

Are there any dietary restrictions required for the use of ColoAlert?

No, this was only necessary for older (chemical) occult blood tests.

How can I obtain the ColoAlert complete kit?

You can order your ColoAlert complete kit directly via our webshop or by telephone under +49 61 31 / 5 54 28 60. You will usually receive it within a maximum of two working days.

How soon should the sample be sent back?

Please bring the return package with the stool samples to the post office or put it in a letter box no later than the day after taking them. The return package is already correctly addressed. If you purchased ColoAlert here on the website, the package is also prepaid!

What happens to the sample in the lab?

Upon receipt of the sample, the ColoAlert laboratory experts extract the DNA contained in the stool sample and examine the human-derived portion for two cancer-relevant mutations and a suspicious total amount of human DNA. The second stool sample in the smaller collection tube is examined for occult blood. The test report will be based on these four parameters and sent to you by mail.

With ColoAlert Plus, we will also send you the test result in advance via encrypted e-mail upon request.

How long does it take until the results are available?

After the receipt of your sample, the laboratory analysis for ColoAlert Basic takes a maximum of nine working days until the test result is sent.

With ColoAlert Plus, our Express Service will take effect: In this case we guarantee processing within a maximum of 5 working days.

How long does it take until I receive the invoice?

You will receive the invoice approximately 7 working days after your test results have been sent, unless you already paid when ordering.

What happens to my sample after the analysis?

Normally, your sample is destroyed immediately.

If you explicitly request this by ticking the appropriate box on the examination order, your sample will be stored anonymously for research, teaching and quality assurance purposes.