Pathology, Molecular Diagnostics, Research: Commitment

PCA3, A New Diagnostic Assay Targeting Prostate Cancer

Press Release
For immediate Release

Avero Diagnostics announces the release of PCA3, a new diagnostic assay targeting prostate cancer and assisting in early identification.

Dallas, Texas, July 16, 2007 - Avero Diagnostics, announces a significant new tool for prostate cancer diagnostics. PCA3, a urine based genetic test for prostate cancer, offers urologists and pathologists a solution for managing patients who have a elevated serum PSA and a negative biopsy result.

PCA3 identifies and quantitates mRNA of the PCA3 gene in prostate cancer cells shed into urine. The PCA3 gene is over-expressed by prostate cancer cells in comparison with all other cells studied. A positive PCA3 test suggests the need for further evaluation, such as an additional prostate biopsy. A patient with a negative PCA3 result following a negative prostate biopsy may just need routine follow up, and possible further evaluation at a later date.

“As an adjunctive molecular assay, the PCA3 compliments existing diagnostic testing methods for identifying prostate cancer,” says Scott B. Shappell, MD, Ph.D., Medical Director and Surgical Pathologist, Avero Diagnostics. “Patients with an elevated PSA and a negative prostate biopsy may have PSA elevation due to other conditions, such as benign prostatic hypertrophy (BPH) or prostate inflammation. PCA3 has a much higher specificity, 70-80% vs. serum based PSA's 20- 30%, and assists physicians who are managing patients with a negative prostate biopsy and an elevated PSA over 4ng/ml.”

Avero Diagnostics is a physician owned and operated pathology laboratory, providing molecular diagnostic laboratory services to pathologists, oncologists, and other clinicians across the country. Dr. Shappell and his team have extensive experience in prostate pathology and expertise in RNA testing, making them particularly qualified to offer PCA3, and the Dallas based Avero Diagnostics is only one of four labs within the United States currently offering PCA3 testing as a clinical laboratory service.

With a commitment to researching and optimizing the practice of molecular and surgical pathology, Avero Diagnostics facilitates the discovery and validation of new molecular diagnostic strategies to improve patient care. Avero Diagnostics has a unique combination of expertise in molecular diagnostics and surgical and cytopathology. Avero Diagnostics is a natural extension of its client's pathology laboratories, providing precise molecular diagnostic services to complement and work with anatomic and clinical pathology results.

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