New "revolutionary" AI breast cancer diagnostic launched

A new breast cancer diagnostic technology which could prevent deaths and save money for organisations like the NHS has been unveiled.

The tool, invented in the UK by medical firm Digistain, has passed clinical studies and peer review, gaining market clearance from the Medicines & Healthcare Regulatory Agency. The tool will help to slash waiting times, reduce the use of chemotherapy and cut the current the COVID-19 hospital backlog.

This radical artificial intelligence concept was developed at London’s Imperial College and Cancer Research UK laboratories under the guidance of decorated pathologist Sir Nicholas Wright and designed with input from 1500 oncologists. It has been successfully trialled with patients from the Nottingham University Hospital and London’s Charing Cross Hospital.

Current testing used by organisations like the NHS is slow and expensive, but this technology is quicker, cheaper and identifies patients who can safely avoid chemotherapy - with more than 99% accuracy. This results in less reliance on chemotherapy, which can have fatal side effects, delivering diagnoses in hours and days rather than weeks, thereby saving health providers more than an estimated 30% on their budgets.

Around 50,000 people are diagnosed with breast cancer in the UK each year, with around 11,500 resulting in death. That equates to approximately 32 each day and it is the fourth most common cause of cancer death in the country. Impacts of delays in diagnosis will result in an estimated 5000 excess deaths from breast cancer for the period 2020-2030.

The streamlined and affordable test provides rapid and cost-effective patient risk evaluation and has potential to eliminate the inequality of care in cancer treatment around the world. Some institutions in India have already adopted the tool, with research funded by the National Institute for Health and Care Research (NIHR) and backed by investment from Y Combinator and Harvard University in the USA, where the technology is set to be rolled out in the coming months.

And the innovative method has the backing of some of the world’s leading voices in oncology, including Professor Carlo Palmieri BSc (Hons), MB BS, PhD, FRCP (UK) - a consultant in medical oncology and former senior lecturer at Imperial College and produced the book ABC of Cancer Care. He is joined by US-based Professor Darius Francescatti MD, JD, FACS, who has more than 20 years’ experience as a breast cancer surgeon and authored Breast Cancer - A New Era For Management. He sits on Digistain’s board.

Digistain CEO and clinical scientist Dr. Hemmel Amrania, who created the technology, said: “Digistain is at the forefront of rapid and cost-effective personalised cancer treatment decision-making. This new technology speeds up a system that is currently too slow and where time and swift action are precious commodities.

“This tool will ultimately save lives and money. In the UK, patients wait weeks for results at a cost of several thousand dollars per test report per patient, with most samples being shipped to the USA. This new approach will also reduce carbon footprint by 93%, therefore enabling organisations like the NHS to meet their net zero commitments.

“Such radical technology will eliminate the use of toxic chemotherapy in many patients, improving outcome while saving the health payer significant costs. We are on a mission to prevent breast cancer patients from unnecessary chemotherapy and to get a diagnosis and treatment plan to them quickly, reducing the pain and anxiety of waiting for results. We have assembled a best-in-class team here, drawing on some of the leading global voices in breast cancer treatment who have helped create a best-in-class product.”

The technology does not rely on a fixed assessment of chemical analysis. Instead, it combines a proprietary optical scan with machine learning to identify patterns invisible to fixed algorithmic approaches. This helps to capture a unique signature from each biopsy and performs an analysis on over 10,000 data points per sample. With this information, Digistain computes a highly personalised risk score which has been validated on over 800 patients in a study reviewed by Cancer Research UK.

The unprecedented trial results were unveiled to the industry earlier this month at the European Society of Medical Oncology conference in Paris. And, in October, Digistain has been invited to take centre stage and present its findings at the prestigious Take the Lead in Breast Cancer Symposium in Las Vegas, USA - a Tumor Microenvironment Working Group (TME) committee led by ex-Presidents of the American Society of Breast Surgeons. The symposium highlights emerging validated diagnostic and therapeutic breast care technologies.

The research has also been recognised in the industry with a series of prestigious awards. These include the Imperial College Outstanding Research Award, a Royal Society Innovation Award and the Cancer Research UK Pioneer Award.

Professor Francescatti said: “There is much concern and evidence that early-stage breast cancer is often unnecessarily over-treated with chemotherapy. This exposes patients to an increased risk of mortality due to chemo toxicity.

“This tool is highly cost effective and would free up hospital resources to deliver better healthcare by reducing the need for expensive and potentially lethal chemotherapy. Digistain is a disruptive technology, and its speed of delivery would be transformative for health providers. It is a game changer which will save money and lives.”