Diagnosing prostate cancer

Prostate cancer is globally recognised as the greatest unmet clinical need for men over 40. A number of compelling clinical factors make it imperative to improve the diagnostic toolset.

A spectrum of diseases

Prostate cancer is now viewed as not one disease, but a spectrum of diseases. It presents in many different forms, its onset controlled by small genetic changes which may vary from male to male. The disease spectrum ranges from non-life threatening (indolent) forms to life threatening illnesses, with variations occurring because genetic differences between individuals make for differences in their cancers.

No single biomarker can identify all prostate cancers

There are intractable problems with existing diagnostic tests based on single biomarkers. Because patients (and thus their cancers) are genetically heterogeneous, no one biomarker can be expected to diagnose all prostate cancers on the spectrum. No existing test can identify whether a particular cancer is indolent or aggressive.

 

A “D” Rating for the PSA Test

 

Since 1990 treatment has relied on the PSA test, biopsies and Gleason scores to diagnose and stage prostate cancers. The global market for the PSA test is currently in excess of 100 million tests per annum.

However the PSA screening test has been roundly criticised by medical opinion leaders as flawed, inconclusive and even dangerous. Around 70% of men diagnosed by this test have an indolent form of prostate cancer, which needs no treatment, and only 30 % have life-threatening illnesses which require treatment. Because the test does not distinguish between these, over-diagnosis is a real and continuing problem.

“there is moderate or high certainty that the [PSA test] has no net benefit or that the harms outweigh the benefits.”
           United States Preventative Services Task Force

Following a 10 year 13,000 men study the United States Preventative Services Task Force (USPSTF) rated the use of the PSA test a “D” as the surgical, radiation and drug therapy treatments undertaken as a result of inaccurate diagnoses all pose significant risks to patients and incur unnecessary health costs to the health system.

Each cancer is different

To give each patient the best treatment options, each prostate cancer needs to be detected and graded on the disease spectrum. Correct identification and staging of each patient’s cancer plays a decisive role in selecting the best treatment.

Caldera Health’s approach

The Caldera Health test, utilising RBAS (RNA biomarker amplicon sequencing technology), effectively becomes a game changer for diagnosing and managing the disease.

This is because it combines a signature(s) of selected RNA biomarkers and a sensitive high-throughput platform that delivers quality results rapidly and cost effectively.

Caldera Health’s approach is to identify the genetic signatures of different prostate cancers across the disease spectrum using gene-based diagnostics and thus, dealing with genetic variations found between individual cancers.

With multiple gene signatures spanning the disease spectrum from healthy to metastatic tissues we are developing a novel suite of diagnostics tests to meet the significant clinical need for the early detection, staging and monitoring the progression of prostate cancer.

 

Caldera Health’s diagnostics will provide clinicians with more useful information and are more cost-effective than current methods.

Caldera Health’s diagnostics are in clinical studies in Auckland, New Zealand. The development of comparable diagnostic tests for prostate cancer are only in their infancy today.