Earlier this year Aureon Laboratories released Prostate Px™, the first in a series of tests that predict prostate cancer recurrence. The test stratifies patients into high or low risk categories for the likelihood of experiencing a return of their prostate cancer after they have had their prostate surgically removed (prostatectomy). In addition, Aureon is in the final stages of development of Prostate Px™ + (www.prostatepx.com/promo/articles) a new predictive test for prostate cancer that will use biopsy tissue, at the time of diagnosis

Approximately 15-40% of patients who have had their prostate removed will develop a serum PSA or biochemical recurrence (BCR). Moreover, a man with prostate cancer who has had a PSA recurrence can still develop a metastasis some eight years post PSA/BCR suggesting that identifying this group of patients early in their treatment program is critical to their overall survival.

The current practice for following patients after a prostatectomy is to test their blood for prostate specific antigen (PSA) to determine whether their cancer is returning. This period can be a time of great anxiety and many patients are searching for additional sources of information in order to make a more-informed decision about possible treatment options. An accurate prognosis is important because the majority of tumors are indolent and require minimal intervention while a subset are more aggressive and early intervention may be valuable.

The Prostate Px test has two endpoints for cancer recurrence:

•PSA Recurrence Px Score describes the likelihood of the patient developing a PSA recurrence within five years of having their prostate removed.

•Disease Progression Px Score describes the likelihood of the patient developing Disease Progression defined as bone/soft tissue metastasis and/or androgen independent rise in PSA within five years of having their prostate removed.

Compared to existing methods, Prostate Px provides a prediction of PSA recurrence with a sensitivity of 96%. In addition, Prostate Px can predict disease progression and does so with a sensitivity of 89%.

Prostate Px benefits patients and physicians at a number of decision points after surgery. The predictive test can:

•Provide a probability of whether a patient, after a prostatectomy, will have a PSA recurrence within five years.

•Predict whether a patient, after a prostatectomy, will have disease progression within five years.

•Avoid possible side effects associated with therapy (e.g. androgen deprivation therapy) for asymptomatic low risk patients.

•Identify patients with high risk of clinical failure who may benefit from increased surveillance or early adjuvant therapy.

•Help relieve anxiety and allow patients, their families and their physicians to decide upon the best treatment regimen moving forward.

•Assist in patient selection for new therapies as part of randomized clinical trials.

Technology:

The basis for the predictive power of Prostate Px is its unique breakthrough technology. Aureon’s System Pathology platform combines histological, molecular and clinical information to predict cancer recurrence.

After prostatectomy, the physician orders Prostate Px and a small section of the prostate tissue sample is collected from the pathology department at the hospital where the surgery was performed and sent to Aureon’s specialized laboratory. Aureon’s approach integrates:

•Histology (tissue): Prostate Px analyzes the cells and other structures in a prostate cancer tissue sample. This results in the generation of specific (quantitative) features for inclusion in the mathematical model.

•Molecular markers: Prostate Px selectively measures specific proteins in prostate tissue samples in order to obtain a unique molecular picture of the patient’s prostate cancer.

•Clinical data: Prostate Px takes into account important clinical information such as the Gleason score and the pathology results from the patient’s surgery.

By combining these sources of information and by applying advanced computer technology and mathematics, Prostate Px is able to provide patients a more thorough picture of their individual risk for recurrent disease.

Next Generation: Prostate Px is just the first in a new generation of predictive tests from Aureon that combines the power of advanced mathematics with biology and clinical practice.

As stated earlier, Aureon is in the final stages of development of Prostate Px™ +, a new predictive test for prostate cancer that will use biopsy tissue, at the time of diagnosis, and Aureon’s system pathology platform to assess future disease severity.

Prostate Px™ + will enable the assessment of future disease severity at the time of diagnosis, thus more information will be available to the patient and their physician prior to the selection or implementation of any therapies.