Metabolon, Inc. announced today the signing of an exclusive multi-year Marketing Agreement with Bostwick Laboratories
The test will be offered for initial cancer evaluation to determine which men are candidates for prostate biopsy, and also for repeat biopsy decision-making for men with prior negative biopsies. Sample testing for Prostarix will be performed in Metabolon’s CLIA-certified, CAP-accredited laboratory utilizing its state-of-the-art mass spectroscopy-based analysis technology. The Agreement provides Metabolon with access to one of the largest urology networks in the United States.
“The Prostarix test is an important new test that will aid in determining whether to undertake prostate biopsy when the clinical evaluation is equivocal,” commented Dr. David Bostwick, Chief Medical Officer and founder of Bostwick Laboratories. “We continue to search for new technologies that exceed our high threshold for clinical utility, and find this novel test from Metabolon to be such a significant advance. The Prostarix test joins a long list of successful new technologies that we have pioneered for urologists and their patients, including PCA3Plus® (formerly uPM3), Prostavysion™, and BladderVysion™.”
“The launch of the Prostarix test is a key milestone in our cancer diagnostics development program,” stated Dr. John Ryals, President and Chief Executive Officer. “We are delighted to have this test being marketed by Bostwick Laboratories, a leader in uropathology with a proven track record in successfully commercializing new products and technologies.”
Prostarix is based on a panel of biochemical markers excreted into urine, including sarcosine, which research has linked to prostate cancer (Sreekumar, A., et. al. (2009) Nature 457, 910-914). Metabolon’s mass spectroscopy-based discovery approach led to the identification of sarcosine and a number of other biomarkers that, when quantified, allow for discrimination of patients likely to have a positive biopsy for prostate cancer from those less likely to have a cancer found on biopsy. In clinical trials the Prostarix test demonstrated increased sensitivity and specificity compared with PSA, provided information about metabolic abnormalities associated with prostate malignancy and enabled physicians to make more informed patient management decisions, especially for those patients with a negative digital rectal exam (DRE) or modestly-elevated serum prostate specific antigen (PSA) levels.
Prostarix is the second laboratory developed test commercialized by Metabolon that was discovered using the company’s powerful global metabolomics platform. “We developed Prostarix by employing a unique and robust systematic biomarker discovery approach in which we used a broad metabolomic survey followed by a targeted (focused biochemical measurement) biochemical profiling approach. This metabolic assessment uses a quantitative liquid chromatography-mass spectroscopy method to accurately measure the concentrations of four metabolites. A Prostarix score is generated that can improve the sensitivity and specificity of prostate cancer risk stratification in men with negative DREs and moderately elevated PSAs,” explained Dr. Robert Wolfert, Vice President of R&D for Metabolon, Inc. Over the past three decades, Dr. Wolfert has led the effort in the development of numerous cancer diagnostic tests, including the first commercial tests to use PSA for the monitoring and early detection of prostate cancer.