World-first tCEC-based cancer screening technology trialled in Singapore

Singapore, November 2020 – Two of Singapore’s leading hospitals and medical research centres, National University Hospital (NUH) and Singapore General Hospital (SGH), are trialling a new diagnostic test capable of detecting traces of early-stage prostate cancer in a small blood sample. 

Developed by Singapore start-up X-ZELL, the blood test was designed to address the shortcomings of existing early detection methods such as prostate-specific antigen (PSA) testing and avoid unnecessary prostate biopsies – a surgical procedure prone to false and misleading results.1,2

Spearheaded by Singapore’s Diagnostics Development (DxD) Hub, a national platform hosted by the Agency for Science, Technology and Research (A*STAR), the blinded, prospective trial will see some 400 asymptomatic patients with suspicion of prostate cancer take the diagnostic test before undergoing biopsy.

Each test result will then be compared to the biopsy outcome to assess whether or not the test could have avoided an unnecessary intervention.3

During a previous blinded trial on 174 patients at Bangkok’s prestigious Siriraj Hospital, X-ZELL demonstrated that it would have been able to prevent more than 70 per cent of unnecessary prostate biopsies without missing any clinically significant cases.4

Building on existing clinical infrastructure

The key to X-ZELL’s new blood test is the ability to identify and visualise tumour-associated Circulating Endothelial Cells (tCEC) from a 10mL blood sample.

Previously considered undetectable in clinical routine, these ultra-rare cells are shed directly from a tumour’s own blood vessels, thus serving as a powerful biomarker for the disease.4

X-ZELL has found a way to extract a single tCEC from five billion healthy blood cells and analyse it remotely using Artificial Intelligence – making for an affordable, non-invasive test that can slot seamlessly into existing clinical infrastructure.

“What’s exciting about tCEC testing is that it is supercharging traditional pathology instead of disrupting a working system. That way you can build on an existing framework and make the technology accessible to more people, more quickly,” explained X-ZELL Founder & CEO, Dr Sebastian Bhakdi.

Singaporean clinicians trailblazing new technology

According to Principal Investigator Edmund Chiong, Associate Professor at the National University of Singapore (NUS) Yong Loo Lin School of Medicine, and Head and Senior Consultant, Department of Urology at Singapore’s National University Hospital, X-ZELL’s tCEC technology has the potential to significantly improve prostate cancer diagnostics in Singapore and beyond.

Associate Professor Chiong said, “When validated, X-ZELL’s new tCEC test could potentially help us identify the disease more accurately and reduce unnecessary further testing, in the hope of improving the current diagnostic pathway. This could be impactful at a significant scale as prostate cancer is one of the most commonly diagnosed cancers in males worldwide.”

“We are proud to be able to trial this approach here in Singapore and look forward to making it available to men in Singaporean and beyond,” he added. 

Agreed joint Principal Investigator Dr Kae Jack Tay on the landmark trial. Dr Tay is Director, Uro-oncology, and Consultant, Department of Urology at the Singapore General Hospital.

“There are many reasons for an elevated PSA reading, and we often need additional tests to determine if it is cancer-related. Some of them are invasive procedures most patients would like to avoid,” he said.

“The tCEC based test does look promising if it is able to inform doctors whether or not additional testing is necessary without putting the patient at risk. It’s a small test but it can make a big difference for the patient.”

Potentially preventing unnecessary interventions

DxD Hub CEO, Dr Sidney Yee, added that X-ZELL’s approach was particularly interesting because it can differentiate between clinically significant and insignificant cases.

“The clinical challenge in prostate cancer diagnostics is to distinguish men with low-risk cancer that does not require intervention, from those who need medical attention. X-ZELL’s approach potentially provides a solution to that question.”

Goal to be simple, pain-free and affordable test

If the landmark study is successful, tCEC testing might become available in Singapore as early as 2021, according to Bhakdi.

“If recent history has taught us anything, it’s that early detection systems are crucial for the health of our community, as well as our economy. tCEC testing could be one such safeguard,” he commented – adding that X-ZELL’s prostate cancer test is just the first step on a more ambitious journey.

“In the long-run, our goal is to develop an affordable multi-cancer test that can be performed as part of an annual health check-up anywhere in the world. To get there, we will focus on one high-risk group at a time, starting with men with suspicion of prostate cancer.”

1Schwenk et al. No Mortality Benefit in Third Major Trial of PSA Screening. JAMA 2018
2Ahmed et al. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. The Lancet 2017
3The study will focus specifically on patients with a diagnostically ambivalent PSA score (below 20 ng/mL, referred to as the “diagnostic grey zone”) and a previous suspicion of the disease.
4Bhakdi et al. Accuracy of Tumour-Associated Circulating Endothelial Cells as a Screening Biomarker for Clinically Significant Prostate Cancer. Cancers, 2019

 

Media Contact:
Sebastian Grote
Head of Strategy, Marketing & Communications
+65 9630 0706
sebastian.g@x-zell.com
www.x-zell.com

  

Background Information
According to the World Health Organisation (WHO), prostate cancer is the third-most common cancer in the world. The only non-invasive tool currently available to detect the disease at an early stage is the controversial prostate-specific antigen, or PSA, test. Due to the low accuracy of PSA testing, results often return inconclusive and require confirmation via tissue biopsy – a surgical procedure known to produce a high rate of negative and false negative results that may be prevented with a more appropriate pre-selection method. X-ZELL’s new blood test addresses that shortcoming by slotting in between PSA and tissue biopsy to ensure only those patients proceed undergo biopsy who really need to.

About DxD Hub
The Diagnostics Development (DxD) Hub is a national initiative in Singapore, led by the Agency for Science, Technology and Research (A*STAR). The DxD Hub aims to accelerate the transformation of innovations into clinically validated diagnostic devices that are ready for market adoption. Through impactful products, empowering local enterprises and anchoring global companies in Singapore, the DxD Hub contributes to the development of an effective diagnostic devices ecosystem in Singapore.

About the National University Hospital
The National University Hospital is a tertiary hospital and major referral centre with over 50 medical, surgical and dental specialties, offering a comprehensive suite of specialist care for adults, women and children. It is the only public hospital in Singapore to offer a paediatric kidney and liver transplant programme, in addition to kidney, liver and pancreas transplantation for adults. The hospital was opened on 24 June 1985 as Singapore’s first restructured hospital. Each year, the Hospital attends to more than one million patients. As an academic health institution, patient safety and good clinical outcomes are the focus of the Hospital. It plays a key role in the training of doctors, nurses, allied health and other healthcare professionals. Translational research is pivotal in the Hospital’s three-pronged focus, and paves the way for new cures and treatment.
A member of the National University Health System, it is the principal teaching hospital of the NUS Yong Loo Lin School of Medicine and the NUS Faculty of Dentistry.

About X-ZELL
X-ZELL’s vision is to save lives by identifying clinically significant cancers early, when there is still time to act and take charge of our health. X-ZELL first made headlines in 2017 when it found a way to routinely locate tumour-associated Circulating Endothelial Cells (tCEC) in a small, 10mL blood sample.  Known to be powerful biomarkers for the early detection of aggressive cancers, tCEC were long considered ‘undetectable’ in clinical routine. X-ZELL overcame the impasse by developing a platform technology that is capable of detecting a single tCEC among five billion healthy blood cells and analysing it using Artificial Intelligence – making for an affordable, non-invasive solution with maximum scalability. Less than a year after that breakthrough, X-ZELL was able to present the world’s first tCEC-based blood test for the early detection of clinically significant prostate cancer – X-ZELL™ Prostate. But one cancer is not enough. X-ZELL’s ambition is to make accurate, affordable tCEC screening available to everyone, everywhere – which is why additional tests for common cancers such as breast, ovarian, colon and lung have already gone into pre-development, with more to come. They all feed into the creation of an AI-driven general screening test that will be able to scrutinise our blood for atypical cells and analyse them on-screen – allowing physicians to manage our health proactively instead of just responding to a disease. 

 

 

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