In 2014 over 233,000 men were diagnosed with prostate cancer and currently about 2.5 million men in the US are living with prostate cancer making it the second most common cancer among males (only after skin cancer). Prostate cancer is also the second most deadly cancer among men with an annual fatality of 29,480.

One out of eight men develop Prostate Cancer in their lifetime; however, not every form of prostate cancer is life threatening. The aggressive form invariably spreads to other organs in the body – particularly the skeleton – and is almost invariably lethal. However, a less aggressive, frequently indolent form of prostate cancer does exist. It is non-life threatening and must be accurately identified and discriminated from the aggressive disease.

It is important to know that a large proportion of the male population develops indolent prostate cancer as they grow older, but treatment may not be necessary.

There is a large unmet need for tests that can correctly identify patients who are at high risk for prostate cancer so that the number of needless biopsies and prostatectomies can be reduced.

Did you know that most men are recommended to undergo prostate biopsy because there are no reliable laboratory tests to unequivocally detect the most aggressive forms of prostate cancer? Out of the 1.3 million biopsies performed each year, 700,000 are negative and 25% are false positives. Aggressive or life-threatening prostate cancer is detected in only about 20% of men. This means that over 700,000 men every year undergo prostate biopsies which could have been avoided if they had access to a more reliable and accurate test. The medical expenditures of all these needless biopsies add up to a total of $808 million.

This procedure also may result in further complications such as secondary infection, incontinence, and sexual dysfunction.

It is important to remember that only the aggressive, metastatic form of prostate cancer is life threatening. The PSA blood test, which is the most commonly used prostate cancer test, often fails to accurately detect slow growing tumors, which over time become more aggressive, spreading beyond the prostate, and can be fatal.

The PSA test is also incapable of distinguishing between the aggressive and indolent forms of prostate cancer. It also fails to evaluate the tumor burden caused by prostate cancer cells that lack the Androgen Receptor. New generation PSA tests may be better, but a large margin for improvement remains.