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A vector illustration of a hand holding a magnifying lens over a cancer cell with a pattern of cancer cells and DNA double helices in the background.
One of the largest barriers to effective screening and diagnosis for many cancer types is the lack of specific, sensitive, and actionable detection methods.
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Easing a Burdened Healthcare System with Improved Cancer Diagnostics

Innovative and sensitive testing methods will significantly cut down the load on clinical labs

Bob Rochelle, MBA

Bob Rochelle, MBA, is an expert in the launch, strategy, and marketing of novel healthcare products and is currently the chief commercial officer for Cleveland Diagnostics.

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Published:Jan 30, 2024
|3 min read
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Photo portrait of Bob Rochelle

Bob Rochelle, MBA, is an expert in the launch, strategy, and marketing of novel healthcare products and is currently the chief commercial officer for Cleveland Diagnostics.

Many cancers are manageable, treatable, or even curable if detected early: A timely and efficient cancer diagnosis is crucial. However, a cancer diagnosis typically requires multiple rounds of testing, numerous appointments, and nuanced decision-making from healthcare providers, adding to the burden on the healthcare system.

One of the largest barriers to effective screening and diagnosis for many cancer types is the lack of specific, sensitive, and actionable detection methods, often leading patients to undergo costly, invasive, and in some cases, unnecessary follow-up testing. Even when cancer is accurately detected, arduous testing can waste valuable time. As many as 50 percent of cancers are detected at an advanced stage and may have become difficult to treat.

Ineffective testing methods lead to the waste of resources, drive up costs of testing and equipment, and render the decision-making process challenging for clinicians. Approximately 30 percent of US healthcare spending is considered “waste,” and therefore, improvements to cancer testing—specifically early cancer detection—can streamline diagnosis and free up valuable resources in the healthcare systems.

Cancer diagnostic advancements in action: Prostate cancer

Prostate cancer screening serves as a perfect example of resource inefficiency spanning the healthcare landscape. Prostate cancer is the second most common cancer in men, with about 1 in 8 men likely to be diagnosed in their lifetime. One of the most common testing tools for prostate cancer is the prostate-specific antigen (PSA) test, which examines the concentration of PSA in the patient’s blood. An elevated PSA test result often prompts follow-up testing, such as a biopsy or an MRI scan, to establish a diagnosis.

Unfortunately, the PSA test has limitations. While PSA is prostate-specific, it is not cancer-specific. PSA results can be influenced by medications, physical activity, and relatively benign health conditions. 

Because the PSA test is not cancer-specific and has a high rate of false-positive results, many patients with an elevated PSA result are sent to biopsies, which, in turn, can put patients at risk of adverse complications. Studies suggest that prostate biopsy is associated with an increased risk of hospitalization, serious infections, and noninfectious complications. Despite an estimated $1.86 billion being spent each year on PSA testing and $2.5 billion on prostate biopsies, approximately 75 percent of men who have a prostate biopsy due to an elevated PSA level are not diagnosed with prostate cancer. 

Testing for PSA isoforms

To improve prostate cancer testing, innovation is shifting away from the status quo; toward cancer-specific proteins. Contrary to other screening approaches that focus on alterations to genetic material, altered proteins are a more direct manifestation of cancer and can provide valuable insights.

Moreover, newly developed tests identify unique structural variations (or isoforms) of PSA, which may be created by cancer cells. Tests focusing on PSA isoforms provide the same sensitivity as the traditional PSA tests but with improved cancer-specificity and can help clinicians triage at-risk patients for undergoing a biopsy. 

PSA isoform testing has led to up to 55 percent less biopsies in men with an elevated total PSA (≥4 ng/mL), a change that could dramatically reduce the number of unnecessary tests and conserve healthcare resources. Such improvements in cancer testing methodologies could make cancer diagnosis more straightforward, lightening the burden on healthcare systems and improving patient outcomes.