Prostate Cancer Prognostic Assay1

AltheaDx is developing a molecular prognostic test to determine probability of relapse for prostate cancer patients.

Identify patients with aggressive disease2

• Apply targeted therapies earlierIdentify patients with aggressive disease
• Improve outcome

Identify patients with good prognosis

• Minimize aggressive treatment
• Improve quality of life

Prospective study to develop relapse vs.
non-relapse classifier

Percent Tumor Calibration is an Integral Part of Data Analysis

All prostate tumors and corresponding biopsy samples are heterogeneous, containing a mixture of tumor, stroma and benign prostate hyperplasia (BPH). A key factor in diagnosis of prostate cancer involves accurate determination of percent tumor tissue used in the sample that is tested. The percentage ratios of each tissue type in the sample directly impacts gene expression data, and failure to calibrate data as a function of tumor percentage will lead to major data artifacts. AltheaDx has developed methods for determining percent tumor tissue in a given sample, adding specificity to our test panels.

Diagnosis and treatment of prostate cancer can be highly subjective.

Although only 20% of cases are aggressive, 75% of patients are treated aggressively, resulting in unnecessary treatments. The AltheaDx Prostate Cancer Prognostic Test is a proprietary genetic panel that can help predict non-recurrent versus recurrent /aggressive forms of prostate cancer, allowing oncologists to make more informed decisions regarding appropriate treatment.

This prognostic test can be used to supplement existing tests including Gleason score and staging to help patients and physicians to make a more informed decision when it comes to choosing treatment options.

Molecular markers provide an inside view of the genetic changes occurring within the prostate tumor, and as a consequence, are able to characterize the tumors in manner that no other test can do.

This prognostic test can be used to supplement existing tests including Gleason score and staging to help patients and physicians to make a more informed decision when it comes to choosing treatment options.

Molecular markers provide an inside view of the genetic changes occurring within the prostate tumor, and as a consequence, are able to characterize the tumors in manner that no other test can do.

The AltheaDx Prostate Cancer Prognostic Panel utilize proprietary XP-PCR multiplexing on a capillary electrophoresis detection platform. The genes were validated through microarray studies (3 studies encompassing 330 patients) with full clinical information. The 70 differentiation genes identified were cross-verified through 3 additional data sets. This work is the result of discoveries made by the multi-university, NIH/NCI funded prostate Strategic Partnering to Evaluate Cancer Signatures (SPECS) program, led by researchers at the University of California. The intellectual property has been exclusively licensed to AltheaDx for the development of these exclusive genetic tests. To read more about the SPECS program’s prostate cancer findings, click here. [Link to the SPECS NIH abstract]

These markers for predicting relapse are currently being validated on the multiplexed XP-PCR platform and will be taken through the FDA for approval. The test will also be provided by AltheaDx in its CLIA certified testing lab in 2010.4