Under a new collaboration agreement, Metamark Genetics Inc, Cambridge, Mass, will serve as the exclusive worldwide sales agent for the Progensa prostate cancer antigen 3 (PCA3) assay from Hologic, Marlborough, Mass.

The Progensa PCA3 assay is the first urine-based molecular test for noninvasive detection of prostate cancer, and quantifies cancer-specific overexpression of PCA3 RNA in patient samples. Specifically, it measures the concentration of PCA3 and prostate-specific antigen RNA molecules in post-digital rectal exam male urine specimens. Used in conjunction with other standard-of-care methodologies, the assay provides clinically meaningful information that improves prediction of repeat biopsy outcomes in men who have had one or more prior negative prostate biopsies.

In 2012, FDA approved the Progensa PCA3 assay for use on Hologic’s semiautomated direct tube sampling systems. The assay is included in the National Comprehensive Cancer Network guidelines for early detection of prostate cancer.

Jerome P. Richie, MD, Metamark.

Jerome P. Richie, MD, Metamark.

“The Progensa PCA3 assay is an exceptionally beneficial tool that accurately classifies ‘true negative’ patients with a high negative predictive value of 90%, enabling the urologist and the patient to make a more informed repeat biopsy decision,” says Jerome P. Richie, MD, chief medical officer at Metamark. “This additional information can significantly alleviate the clinical consequences and cost of proceeding with an unnecessary repeat biopsy.”

The two companies also intend to develop a second-generation assay for early detection of prostate cancer on Hologic’s Panther instrument, an integrated, fully automated testing platform capable of serving both high- and low-volume laboratories. When development of the second-generation assay is complete, Metamark will also have the right to copromote the second-generation assay in specified territories.

Tom West, Hologic.

Tom West, Hologic.

“Metamark’s success in delivering high-value diagnostic and prognostic tests for the prostate oncology market provides a strong foundation for this collaboration,” says Tom West, president of diagnostic solutions at Hologic. “We very much look forward to leveraging Metamark’s proven urological cancer care expertise as we seek to expand our footprint in the field of prostate oncology.”

Ken Weg, Metamark.

Ken Weg, Metamark.

“Hologic has demonstrated tremendous leadership within the diagnostic space, providing greater certainty through innovative technology, and improving patient lives,” says Ken Weg, president and CEO of Metamark. “Metamark is eager to proceed with this exciting partnership to further advance prostate cancer detection, and continue our mission to supply more comprehensive information to urologists across the complete prostate cancer continuum.”

Financial terms of the collaboration agreement between Metamark and Hologic were not disclosed.

For more information, visit Metamark and Hologic.