Detecting and treating cancer early improves outcomes for patients. The trouble with prostate cancer is that one of the most common tests – for the prostate specific antigen (PSA) – does not give a clear-cut diagnosis. Nor does it say much about prognosis: older men can have enlarged prostates for a range of reasons, many of which are not life-threatening.
For most men with elevated PSA levels, the next step is a biopsy: an invasive and uncomfortable procedure where doctors slice a small sample of tissue for laboratory analysis.
By some estimates, around 20 percent of prostate biopsies result in a cancer diagnosis. But for those who get the all clear with a first biopsy there is concern about the possibility of a false negative and additional biopsies may be required before cancer can be diagnosed or ruled out.
This means that no analysis on improving prostate cancer diagnoses is complete without considering patient outcomes for two distinct groups: those who have prostate cancer and need swift intervention, and those who do not have cancer and should be spared needless discomfort and worry.
In short, improving the diagnosis of prostate cancer would allow healthcare resources to be targeted to those who need them most, speeding up the system, avoiding the distress caused by the uncertainty of existing diagnostic methods, and reducing costs.
Jan Groen, Chief Executive of diagnostics specialist MDxHealth, believes that more accurate diagnostics can deliver better results for patients and healthcare services. “Early diagnosis is critical to an improved patient outcome, but obviously it is also important to avoid unnecessary invasive procedures, which are costly to the healthcare provider and uncomfortable for the patient,” he says.
MDxHealth’s new liquid-biopsy test identifies men with a high-grade risk profile for aggressive prostate cancer. “By using this risk profile, physicians can ensure that patients at high risk can benefit from biopsy and early detection whilst those at low risk may avoid invasive procedures with routine follow ups and screening,” Groen says.
The Herstal, Belgium-based company has been clocking up endorsements from health insurers and signing new distribution agreements in Europe, the US and Israel. Some payers, in both government and private insurance systems, see tests like these as having the potential for better prostate cancer outcomes for individuals while reducing overall use of health services.
It is a view that Groen is pleased to see having an impact. “We believe that our tests improve outcomes and reduce costs to healthcare systems by helping to reduce the number of unnecessary biopsies and MRI [magnetic resonance imaging] in men exhibiting symptoms of prostate cancer,” he says.
According the MDxHealth, using its test reduces the need for biopsies and MRI scans by 50 per cent, thereby reducing healthcare costs.
One of the big frustrations for patients and health professionals alike is the number of inconclusive results from traditional testing methods. Some men undergo three or four biopsies before getting a clear result.
“Forty three per cent of patients with a negative result following their initial biopsy will undergo a repeat biopsy,” says Groen. “Aside from the significant costs and risks associated with these procedures, let’s not forget that repeat biopsies also contribute to an increased risk of infection and hospitalisation.”
New diagnostic tests, like those developed by MDxHealth, help urologists to confidently rule out prostate cancer while identifying those who truly need repeat testing.
This is positive for patients and policymakers alike. “We believe that the tests we provide will help doctors to diagnose patients with high-grade cancer and save those with most likely no, or very low, risk of non-aggressive cancer a lot of worry,” Groen says. “Furthermore, we satisfy the healthcare system by avoiding a lot of costly procedures and unnecessary treatments.”
High-end diagnostics are playing an important role in supporting the move to value-based healthcare. Groen, a veteran of the diagnostics sector with over 30 years’ experience, senses a shift in how innovations are valued.
“I am very optimistic about [value-based healthcare],” he told Healthy Measures. “I believe we are at a crossroads where diagnostic companies, pharmaceutical companies and healthcare systems are starting to work closely together to really make an impact on our shared goal - improving the well-being of patients.”
The drive to measure outcomes so that they can be improved has been gathering momentum. Prostate cancer is an area of particular interest, not least because outcomes can vary so significantly.
For example, the Martini Klinik in Germany has successfully decreased rates of incontinence and erectile dysfunction while preserving top-of-the-class survival rates.
Efforts to agree universal standards on prostate cancer outcomes – such as those proposed by ICHOM and others – are seen as a way to spread best practice, prioritising outcomes that matter to patients.
However, Groen warns that taking a universal approach to patient care could be a drag on highly-innovative areas of healthcare. “Today taking biopsies combined with pathology is more or less the universal standard on prostate cancer outcomes,” he says. “But the field of molecular diagnostics is moving so fast it would hamper innovation if we lock our self into a universal standard.”
Instead, he prefers the flexibility offered by the US system where new test options are reviewed on a regular basis and are subsequently voted in or out of the clinical guidelines.
So while molecular diagnostics may play a vital role in improving outcomes for people with suspected prostate cancer, the debate continues on how best to deploy innovative technologies.