The trials will utilize the Dxcover Liquid Biopsy Test to detect cancer at its earliest signs
Glasgow, Scotland, January 9, 2024
Dxcover Limited, a clinical-stage diagnostics company pioneering multi-omic spectral analysis (MOSA) for early detection of multiple cancers, today announced it is initiating three pivotal clinical trials measuring efficacy of the company’s liquid biopsy technology for the detection of brain, colorectal and lung cancer.
The company has launched its EMBRACE study, a 2,200-patient trial focused on the early detection of brain cancer. Dxcover® Brain Cancer is a qualitative in vitro diagnostic (IVD) test analyzing blood serum by infrared spectroscopy to detect the signals indicative of brain cancer. This highly sensitive test is to help determine the necessary treatment of patients presenting vague symptoms in primary care environments. The results of the test would prioritize individuals who require a confirmatory brain scan, potentially enabling earlier detection to save lives and reduce healthcare costs. The Dxcover Brain Cancer test has been developed over four years with clinical support from NHS Lothian. This pivotal study is partially funded by a €2.5m grant from the European Innovation Council.
The CREATE2 trial will be conducted to evaluate diagnostic accuracy for colorectal cancer and high-risk adenoma in patients undergoing a colonoscopy. The study will have two recruitment pathways, one in the US and one in the UK, each with 700 patients. The US cohort will be assessed in the average risk population 45-84 who are intending to undergo a screening colonoscopy, while the UK cohort will be assessed post-referral at colonoscopy. CREATE2 aims to validate the previous CREATE study which showed Dxcover’s ability to achieve accurate detection of pre-cancerous lesions and stage 1 colorectal cancer, detection at these stages will enable a positive impact on patients’ lives.
The SPIRALS trial is focused on the management of indeterminant pulmonary nodules by scanning for nodules in the size range between 0.8 - 3.0 cm range. At this size range the nodules are small, however 80% have an intermediate risk score where next steps are unclear resulting in unnecessary surgery and missed cancer diagnoses. Dxcover will be analyzing more than 1,800 samples in order to provide a rapid, cost-effective tool that can help patients receive the correct next steps in their journey.
“Each cancer follows a unique development path, and these are important trials to assess brain, colorectal and lung cancer separately to zero in on the distinct triggers of each disease and, based on the results, identify the most effective treatment for each patient,” said Professor Matthew Baker, Founder and CEO, Dxcover. “As the medical community gathers this week in San Francisco for what is always one of the most significant gatherings in the healthcare industry, I’m looking forward to meeting with like-minded partners whose mission is to eradicate the devastating effects of cancers. At Dxcover, we are firm believers that the key to improving patient outcomes lies in the early detection of cancer, expanding intervention and treatment options. Not only does this have the potential to enhance the efficacy of medical intervention, but also contributes to prolonging and promoting healthier lives.”
The Dxcover Cancer Liquid Biopsy test uses Fourier transform infrared (FTIR) spectroscopy and machine learning algorithms to build a classifier of the resultant spectral profiles to detect cancer and can be fine-tuned to maximize either sensitivity or specificity depending on the requirements of specific disease pathway.
For further information go to https://www.dxcover.com/science
About Dxcover Limited
Dxcover is a clinical stage liquid biopsy company that has pioneered Multi-Omic Spectral Analysis (MOSA-Dx) via their PANAROMIC™ Dxcover® Platform for early detection of cancer & pre-cancer from a simple blood sample. The platform uses infrared spectroscopy with AI algorithms to detect the presence or absence of disease. Having initially proven the technology in the detection of brain cancer, the company expanded to eight cancers in 2022 and demonstrated high accuracy detection of Stage I and Stage II tumors. A multi-centre trial of Dxcover ® Brain Cancer is underway in Europe, and the company is also advancing the Dxcover® Colorectal Cancer test, where they have shown excellent sensitivity for pre-cancerous adenoma, to tackle one of the leading causes of death worldwide. Dxcover is based in Scotland, United Kingdom and will incorporate in the USA in 2024.