Episode 1

Are we serious about prostate health?

Often underestimated, prostate cancer continues to be a significant threat to men’s health. An estimated 1.1 million men worldwide are diagnosed with the disease every year, some 400,000 die of it. That’s about 45 men every hour, every day. And the numbers are rising.

According to new data by the American Cancer Society, the death toll from prostate cancer is bound to increase 10 per cent year-on-year in 2018 alone. That’s one prostate cancer death every 18 minutes.

In the UK, new figures reveal that 11,819 men died from prostate cancer in 2015 (data released with a time delay) – making it the third most common cause of cancer death after lung and colorectal, even overtaking breast cancer, which resulted in the death of 11,442 women.

All these cases result from a disease that is largely treatable when detected early. And yet, that’s exactly where the problems begin – detecting prostate cancer with the tools currently at our disposal is not exactly an accurate science.

Why science doesn’t have the answer – yet

Even the well-known Prostate-Specific Antigen (PSA) blood test is “hardly more effective than a coin toss”, according to Richard Ablin, the very man who discovered it.

He says there is no sufficient evidence to recommend routine screening based on PSA, with doctors at risk of finding low-grade disease and “over-treating” healthy patients that don’t actually need to take action – especially in what is commonly known as the diagnostic grey zone between PSA readings of 4-10ng/mL (in some cases defined as 4-20ng/mL).

The same is true for traditional tissue biopsies. Despite being widely accepted as the ‘gold standard’ for prostate cancer detection, some 25 per cent are false-negatives, which can make it seem like you are healthy, but actually carry the disease. Moreover, in the absence of a solid non-invasive screening tool, another 50 per cent of them are performed on healthy people who don’t have cancer.

That’s not a good track record for a test with side effects ranging from rectal bleeding and infection through to incontinence and impotence.

Even worse, randomised clinical trials (the most thorough form of testing the effectiveness of an assay) have shown that even if tissue biopsies are supported by high-tech imaging technology, chances of finding or missing the disease on the first attempt hardly change.

As a result, a dangerous diagnostic void has formed that may be responsible for the recent rise in prostate cancer incidence around the world – and the bewilderment of a whole generation of urologists.

So what’s next? According to Jamie Bearse, President of US lobby group ZERO, putting a halt on prostate cancer detection in general can’t be the solution. “A drop in cancer diagnosis rates among men means grave consequences for some,” he warns – adding that all efforts should be made to find aggressive forms of the disease when there is still time for treating them. “It just doesn’t add up. Knowing your risk and taking steps to identify aggressive cancers should decrease mortality.”

Do we need a change in perspective?

Despite the rising death toll from prostate cancer, the consensus among urologists is that without the help of additional “filters” that put existing tests like PSA into perspective and help qualify patients for follow-up testing, detecting the disease will continue to be a question of educated guessing.

Many such filters have come and gone over the past decade, yet none of them managed to make a lasting impact on clinical routine.

That doesn’t mean we are out of options, though. Driven by agile start-ups that are willing to explore new avenues of thought, research into prostate cancer detection is once again picking up speed. X-ZELL is one such pioneering force.

Based out of Delaware (USA), Bangkok (Thailand) and Singapore, we are developing a new assay to end diagnostic deficiencies in prostate cancer detection – and with it thousands of avoidable deaths.

Aptly named X-ZELL Prostate™, our new add-on test may be able to detect aggressive, early-stage cancer cells in small, 10ml blood samples, and has already proven itself in various clinical trials across Southeast Asia (contact us for details). Right now, it is undergoing final clinical valuation for a future market rollout.

Using cutting-edge technologies such as hMX™ Magnetic Separation and Cryoimmunostaining™, which make cancer cell visible that have been considered virtually undetectable until now, X-ZELL Prostate™ will help physicians filter out low-risk prostate cancer patients with an ambiguous PSA reading so that only those undergo further (potentially risky) testing that really need to.

All that is backed by data from our first pilot study, which covered more than 170 patients. It demonstrated that we can avoid more than 70% of biopsies without missing cases of clinically significant cancer in the PSA grey zone.

More than just another test

Richard Ablin was right – screening based on PSA alone doesn’t make a lot of sense. The much talked-about PSA grey zone doesn’t rule out prostate cancer, but it also doesn’t rule it in. We already know the results: over-diagnosis and over-treatment.

X-ZELL Prostate™ was designed to navigate that realm more confidently and help doctors qualify patients for active surveillance or additional testing. As such, it’s more than just another test. Once fully validated, it could be the quality assurance urology has been waiting for and a lifeline for patients that fall through the gaps for fear of over-treatment.

How can X-ZELL Prostate™ make a difference?

X-ZELL Prostate™ is a highly sensitive blood test that allows for tumour-associated Circulating Endothelial Cells (tCEC), ultra-rare cells shed directly from the tumour’s own blood vessels, to be detected at miniscule quantities in the blood.

Though tCEC are shed from tumours less than 1mm in size (they themselves measure 10-100µm in size), they are shed from earliest stage tumours – allowing us to provide early and accurate cancer detection through our patented technology and detection mechanisms.

Best of all, research has shown that tCEC may be able to help us distinguish between dormant and aggressive disease, meaning X-ZELL Prostate™ will not only be able just find the disease where other tests fail to detect it, but also won’t recommend patients for treatment if the disease won’t affect them anyway.

How come I’ve never heard of X-ZELL?

X-ZELL is a young start-up that first stepped onto the global stage in 2016 following a Top 10 finish at Y Combinator’s Winter Demo Day.

We have since finalised various clinical trials throughout Southeast Asia, where our research lab is based, to ensure X-ZELL Prostate™ would not only perform reliably, but do so in a routine clinical setting – ensuring doctors receive results they can actually work with.

As a result, X-ZELL Prostate™ first received approval for use in Thailand (as a so-called Lab-Developed Test, or LDT), but we are working hard to confirm additional global release dates very soon.

After all, prostate cancer is quickly becoming a major threat to men’s health worldwide, and with every hour we waste, 45 men die of the disease. Time to step up and take the guesswork out of cancer detection.

Sources: X-ZELL Inc., National Cancer Institute, Globocan, Movember Foundation, ZERO (formerly NCPP), EAU-ESTRO-SIOG Guidelines on Prostate Cancer


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