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NEWS ALERTS

COLOALERT

TARGET CONDITION

COLORECTAL CANCER

37 Million
Tests per year in the US
estimated potential: 112M pop. ÷ 3 (years) @100% compliance 1

52 Million
Tests per year within 10 years
estimated potential: 157M pop. ÷ 3 (years) @100% compliance 2

19 Million
Colonoscopies each year in USA 4

52,980
Expected deaths in US, 2021 3

~38.8%
Age 50 to 75 have never been screened (in USA) 5

$4.0B
Total US Market Opportunity 6

$6.0B
Total EU Market Opportunity 6

Screenings should START AT 45 YEARS OF AGE

Recent FDA decisions suggest that screening should be conducted once every three years starting at age 45.

Currently, there are 112 Million Americans aged 50+, a total that is expected to increase to 157 million within 10 years.8

Risk Group Patients 7
  • BMI > 30
  • High-fat/-sugar nutrition
  • Consumption of red/processed meat
  • Consumption of tobacco/alcohol
  • Chronic bowel diseases
  • Breast cancer
  • Diabetes mellitus type 2, etc.

1 Internal calculations per number of annual tests.   2 Internal calculations per number of tests over ten years.   3 Predicted deaths from CRC in USA – Cancer.org.   4 19 million colonoscopies annually – iDataResearch.com.   5 Percentage of screening in USA – Centers for Disease Control & Prevention.   6 Internal calculation: 112M individuals/3 years in U.S.; 239M individuals/3 years in Europe.    7 Colorectal cancer risk factors – Cancer.org.    8 Population Reference bureau – prb.org

COLOALERT

OUR FLAGSHIP PRODUCT

PATIENT KIT: Simple, Fast, Accurate and Non-Invasive

Patients receive a simple kit that includes instructions, a stool collector and shipping instructions to return the kit through regular mail to their local lab for testing and results. IT’S THAT EASY.9

Visit www.coloalert.com

  • A PCR-based CRC early detection stool test
  • Up to 60% fewer missed cases compared to fecal immunochemical test (FIT) 10
  • Non-invasive, no preparation or sedation, no time off work
  • 98% patient satisfaction – Easy product to use 11
  • Designed to offer affordable CRC screening solutions

9 Currently not approved for use in the USA

10 Comparing ColoAlert sensitivity with FITs (Gies et al. Gastroenterology 154/2018)

11 98% overall satisfaction with ColoAlert in our internal customer survey.

A STRONG PARTNERSHIP FOR SUSTAINABLE GROWTH

DNA extraction for our flagship product ColoAlert is now automated on the Thermo Scientific™ KingFisher™ Apex.

This essential partnership enables laboratories around the world to increase their testing capacity and to optimize their resource allocation.

  • Automated DNA extraction with magnetic particles
  • Tailored protocol for ColoAlert
  • Up to 96 samples per run in ~ 2 hours*
  • Brings convenience, performance and reproducibility to the ColoAlert workflow

* Extraction time, does not include sample pre-treatment. For Laboratory Use. © 2022 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.

Proprietary state-of-the-art technology

  • Colorectal cancer begins when cells in the intestine undergo genetic mutations. Tumor cells shed into the intestines. Stool samples can be examined for tumor DNA using PCR technology.
  • Polymerase chain reaction (PCR) is used to rapidly make millions to billions of copies of a specific DNA sample and only requires a very small sample of DNA to amplify it large enough for detailed study.
  • ColoAlert utilizes proprietary methods to analyse the cell DNA for specific tumor markers.
  • ColoAlert is designed to detect tumor DNA and detect 85% of colorectal cancer cases - often in the earliest stages of the disease.*
  • Ease-of-use drives ongoing patient adherence as the ColoAlert method requires very small samples compared to ColoGuard.

*Dollinger MM et al. (2018), ClinLab 64 (10), 1719-1730 and Gies et al. (2018). Gastroenterology 154 (1), 93-104.and Cooper GS et al. (2018). Dig Dis Sci. 63 (6), 1449-1453. * 18 study centres, 566 patients, 10/2018 and Amani et al. (2019). Clin. Lab. 65:1751-1754.

COLOALERT PRODUCT WEBSITE

Visit English Website: https://www.coloalert.com

Visit German Website: https://www.coloalert.de

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