For Medical Professionals

Importance of Prostate Cancer Diagnosis and Prognosis

Biomarkers have great potential to improve cancer diagnosis and treatment. However, despite progress in new technology development (such as genomics, proteomics, metabolomics, next-generation sequencing, etc.) and tremendous resources and efforts being devoted to cancer biomarker research with publications of many thousands of biomarker discoveries, few clinically useful cancer diagnostic or prognostic biomarkers have been successfully developed and validated.

Prostate cancer is the second most common cancer in men and the second leading cause of cancer-related death in men.

Accurate prostate cancer screening and diagnostic tests have tremendous clinical benefit:

  • No “false-negative” diagnosis and “under-treatment” resulted from low sensitivity of current tests: find and treat prostate cancer before it becomes aggressive and lethal
  • Outcome: ~100% cure rate, avoid tumor recurrence, metastasis and mortality

  • No “false-positive” diagnosis and “over-treatment” resulted from low specificity of current tests: non cancer patients do not get mis-diagnosed or treated; low-risk and indolent prostate cancer only needs surveillance
  • Outcome: Avoid unnecessary treatment, surgery and patient suffering, greatly reduce healthcare cost

Accurate prostate cancer prognostic tests have tremendous clinical benefit:

  • Metastatic cancer prognostics: identify patients who have or will develop metastatic prostate cancer so patients will receive most suitable treatment
  • Cancer recurrence prognostics: identify patients who will or will not have cancer recurrence so patients will receive most suitable treatment based on cancer recurrence potential
  • Survival prognostics: predict patient survival time so patients will receive most suitable treatment based on their survival prediction
  • These prognostic tests provide personal medicine guidance on prostate cancer treatment: avoid both “under-treatment” and “over-treatment”
  • Outcome: Increase cancer remission, reduce patient suffering and mortality, and lower healthcare cost.

Shortcomings of Current Prostate Cancer Diagnostic and Prognostic Methods

Currently no accurate and ideal prostate cancer diagnostic or prognostic test is available to give accurate cancer diagnosis or provide accurate and actionable clinical guidance to cancer treatment. No test has high sensitivity (>90%), high specificity (>90%) and high AUC (>0.9):

  • Biopsy: invasive and expensive; low specificity: high rate of false negative so negative biopsy needs to be repeated for accurate diagnosis; cannot be used for cancer screening or prognosis
  • Existing biomarkers such as PSA test: all have low sensitivity/specificity to give accurate diagnosis or prognosis
  • Clinical or pathological parameters (such as age, Gleason score, cancer staging): all have low sensitivity/specificity to give accurate prognosis

Prostate cancer is a slow-growing and heterogeneous cancer. At molecular level, it consists of many subtypes of prostate cancer. Many gene alterations contribute to prostate cancer tumorigenesis and metastasis. Therefore no single biomarker, clinical or pathological parameter can provide accurate diagnosis or prognosis.

As a result of low sensitivity of current prostate cancer diagnostic tests, many patients were not detected by current diagnostic methods, therefore missed the opportunity to be treated early, which leads to mortality and prostate cancer as the second leading cause of cancer-related death. On the other hand, many men without cancer had to endure invasive and repetitive biopsies due to the low specificity of the current testing methods. Without accurate prognostic test, many indolent prostate cancer patients had to endure unnecessary treatment including surgery, radiation therapy and chemotherapy while patients with aggressive prostate cancer did not receive sufficient treatment that result in cancer recurrence, progression, metastasis and mortality.

Advantages of Our Products

  • High accuracy: higher sensitivity and specificity than existing tests
  • Clinical benefit: provide actionable guidance to cancer treatment
  • Quantitative measurement: assessing expression levels of multiple biomarkers involved in prostate cancer
  • Non-invasive: only need patient urine sample or biopsy tissue sample already taken from patient
  • Easy procedure: test is easy to run, only needs real time PCR machine, can be done by most clinical labs
  • Fast result: test result is available within the same day
  • Inexpensive: cheaper than many existing test methods by testing multiple genes at the same time with multiplex PCR technology

Clinical Validation

Our products have been validated by multiple retrospective clinical studies with consistently high sensitivity and specificity. Currently we are conducting a prospective, multi-center clinical trial to further validate the products.

If you or your hospital is interested in collaborating with us to conduct more clinical studies or join our ongoing clinical trials, please contact us at: