**Healthcare Challenge** Colorectal cancer (CRC) is a major health concern in the UK, with more than 44,100 people diagnosed every year. Early detection is crucial, as survival rates are significantly higher when cancer is caught in the early stages---90% at Stage I, compared to just 15% at Stage IV. Despite this, over 60% of CRC cases are diagnosed at advanced stages, leading to 16,800-deaths annually and costing the NHS £1.74BN. One of the main challenges is that early-stage CRC often has few visible symptoms, and current screening methods, like stool tests, have low sensitivity for detecting early cancers (around 40% for T1 tumours). This means that many people are not diagnosed until the cancer is more advanced. There is an urgent need for more effective, non-invasive, and affordable ways to detect CRC earlier. **Novel Approach** Tagomics Ltd has developed an innovative solution called InterlACE, a blood-based test that targets specific changes in DNA, known as unmethylated CpG regions, which are linked to cancer. This approach identifies and enriches the circulating tumour DNA (ctDNA) found in the blood without damaging the DNA, enabling highly detailed analysis using artificial intelligence . By preserving important genetic information, this method allows for a comprehensive assessment of cancer markers using a single sequencing run. Tagomics' platform has demonstrated significant advantages over existing tests, including: * Higher sensitivity for early-stage cancer detection (over 98% compared to less than 83% in competing tests). * Targeted towards early cancer detection (hypomethylation) particularly for precancerous growths (adenomas), which are often missed by other methods. * Lower DNA-input required for testing, down to 1ng, making the process widely deployable with a single blood draw. * Faster turnaround time for results and lower costs compared to current options. **Project Focus** The InterlACE-CRC project aims to create a highly-sensitive (90%+), fast diagnostic test for early detection of colorectal cancer, especially in its early stages. The main goals are: * **Developing the platform**: Building a working version (MVP) of the InterLACE-CRC system. * **Validating the process**: Testing integration with Agilent's SureSelect panels to detect key cancer mutations. * **Identifying biomarkers**: Finding and confirming unique signatures for colorectal cancer and its precursors. * **Analytical validation**: Collecting data from 400-samples to ensure high sensitivity (90%+). * **Scaling production**: Expanding production of key enzymes and cofactors to meet commercial demand. By achieving these outputs, Tagomics aims to provide a breakthrough in CRC diagnostics, enabling earlier detection, more effective treatments, and better outcomes for patients.

Cancer is a growing concern globally, with cases set to rise to 21.6M by 2030 (American Cancer Society) with a cost of $458B. Cancer cases in the UK alone are set to rise to 514,000 cases per year by 3035 and the cost of care is predicted to be £15.3B in 2021 alone (NHS). Cancer also has a significant economic expense of around £7.6B per year in the UK, with around 53% of patients seeing a fall in income by at least one income bracket (Pfizer). Despite clear evidence that early detection saves lives, there are still low compliance rates with screening tests (e.g. colonoscopy, mammogram, smear test etc) due to the invasiveness of these approaches. As a result, less invasive methods of detection have been much sought-after, and a number of simple blood-based tests have been successfully commercialised to address these challenges. However, the low sensitivity/specificity of these approaches makes early detection and identification of the location of the cancer, difficult. Chemical modifications to our DNA called 'methylation' control which of our genes are switched on or off. Identifying the location of DNA methylation marks and quantifying and their effects allows us to develop more effective detection tests. However, reading these modifications can be difficult and prohibitively expensive using existing technologies. Tagomics is a spin-out from the University of Birmingham, founded to ensure that our fundamental research reaches the clinic and that we deliver a tangible improvement in cancer diagnosis and treatment, as a result. Our novel platform technology captures the unmodified (switched-on) locations of the genome, allowing for specific and straightforward analysis of the changes that occur during disease. The sensitivity of our approach opens up the possibility of simple, accurate and early detection of cancer and the tissue from which it originated, from a simple non-invasive blood test. Routine screening and earlier detection of cancer will mean clinicians can make more informed treatment decisions sooner in the cancer development pathway. Ultimately, this will reduce the duration and cost of therapy, improve patient outcomes, increase survival rates and decrease the burden on our stretched healthcare system. Tagomics will apply its innovative technology to discover new markers of cancer and through the development of strategic partnerships, we will turn these disease markers into world-leading clinical tests capable of detecting and diagnosing cancer earlier, with the ultimate aim of detecting and assessing multiple cancers from the same single blood draw.