Need for Developing Better Prostate Cancer Diagnostics and Prognostics
Prostate cancer is one of the most prevalent cancers affecting millions of men worldwide. In US, prostate cancer is the second most common cancer in men and the second leading cause of cancer-related death in men (according to American Cancer Society):
- 1 in 6 men will get prostate cancer, 241,000 Americans were newly diagnosed with prostate cancer in 2011
- 1 in 36 men will die from prostate cancer, 34,000 men died from it in 2011
Prostate cancer is also very prevalent in other countries: 0.214% of men have prostate cancer in Europe and it is 6th most prevalent cancer in China.
Currently no ideal prostate cancer diagnostic or prognostic test is available. No clinical or pathological parameter, no biomarker or panel of biomarkers has sufficiently high sensitivity and specificity that is able to give accurate cancer diagnosis or provide accurate and actionable clinical guidance to prostate cancer treatment.
Our Technology and Products
We developed a proprietary biomarker discovery platform to identify and
validate biomarkers important for cancer tumorigenesis, progression and
metastasis. By testing with samples from prostate cancer patients, normal
prostate and benign prostate lesions, we have identified several
biomarker-panels that are able to detect and diagnose cancer, to distinguish
aggressive and non-aggressive cancer, to distinguish metastatic and
non-metastatic cancer, and to predict cancer recurrence and patient
survival, with very high sensitivity and specificity. Based on these
biomarker-panels, we have developed test products that can accurately and
quantitatively measure gene expression levels of the biomarkers in the panel
by using Real-Time quantitative PCR (Real-Time qRT-PCR) technology. We
created our proprietary algorithm to give diagnosis or prognosis based on
gene expression levels of a patient’s biomarker-panel.”
Using our discovery platform, we have developed four novel products for prostate cancer diagnosis and prognosis that can accurately diagnose prostate cancer and give treatment guidance. Our products can distinguish prostate cancer from normal or benign prostate lesion, distinguish aggressive prostate cancer that requires immediate treatment from indolent prostate cancer that needs only surveillance, distinguish patients with metastatic cancer or will develop metastatic cancer from patients without metastatic cancer, distinguish patients who will have cancer recurrence from patients who will not, and predict patient survival time.
Our Testing methods
Our products detect a panel of differentially expressed prostate cancer-specific biomarkers. Our tests can be conducted in both urine samples and prostate biopsy tissue samples.
Below is a schematic diagram of our testing procedure:
Our Product Advantage
- Highly accurate and actionable biomarker tests: higher sensitivity and specificity than existing tests
- Quantitative: measuring expression levels of multiple biomarkers involved in prostate cancer
- Non-invasive: only need patient urine sample or biopsy tissue sample already taken from patient
- Fast testing: result is available within the same day
- Easy testing: test is easy to run, only needs real time PCR machine, can be done by most clinical labs
- Inexpensive: using multiplex PCR technology to test multiple genes at the same time to lower test cost
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