Metamark Genetics, Inc. To Serve As Exclusive Sales Agent For Hologic’s Proprietary Prostate Cancer Test

Metamark Will Commercialize the Progensa^® PCA3 Assay Worldwide

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Metamark Genetics, Inc. (“Metamark”), a leader in developing and commercializing high-value urologic oncology products, today announced that it has entered into a collaboration agreement with Hologic (Nasdaq: HOLX), pursuant to which Metamark will serve as the exclusive worldwide sales agent of Hologic’s Progensa^® PCA3 assay.

“This additional information can significantly alleviate the clinical consequences and cost of proceeding with an unnecessary repeat biopsy.”

The Progensa^® PCA3 assay is the first urine-based molecular test for noninvasive prostate cancer detection, and quantifies cancer-specific overexpression of prostate cancer antigen 3 (PCA3) RNA in patient samples. The U.S. Food and Drug Administration approved the Progensa^® PCA3 assay for sale and marketing in the United States in 2012 for use on Hologic’s semi-automated DTS systems, and it is included in the National Comprehensive Cancer Network Guidelines for early detection of prostate cancer. Used in conjunction with other standard-of-care methodologies, the Progensa^® PCA3 assay provides clinically meaningful information that improves prediction of repeat biopsy outcomes in men who have had one or more prior negative prostate biopsies.

“The Progensa^® PCA3 assay is an exceptionally beneficial tool that accurately classifies ‘true negative’ patients with a high negative predictive value of 90 percent, enabling the urologist and the patient to make a more informed repeat biopsy decision,” said Dr. Jerome P. Richie, 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 system, an integrated, fully automated testing platform capable of serving both high- and low-volume laboratories, to take advantage of the large installed base of Panther^® systems among commercial and hospital clinical laboratories. Upon completion of the development of the second-generation assay, Metamark will also have the right to co-promote the second-generation assay in specified territories.

“Metamark’s success in delivering high-value diagnostic and prognostic tests for the prostate oncology market provides a strong foundation for this collaboration,” said 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.”

“Hologic has demonstrated tremendous leadership within the diagnostic space, providing greater certainty through innovative technology, and improving patient lives,” said 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.

About the Progensa^® PCA3 Assay
The Progensa^® PCA3 assay from Hologic measures the concentration of prostate cancer gene 3 (PCA3) and prostate-specific antigen (PSA) RNA molecules in post-digital rectal exam (DRE) male urine specimens. The resulting PCA3 score predicts the results of repeat biopsies more accurately than traditional serum PSA testing in men who have had one or more previous negative prostate biopsies. When used with other patient information, the Progensa^® PCA3 assay may help address some challenges urologists face with identifying prostate cancers, while reducing unnecessary repeat biopsies.

About Metamark^®
Metamark Genetics, Inc. is a privately-held biotechnology company founded to develop novel, function-based prognostic and diagnostic tests aimed at improving cancer care. The company’s proprietary genomic and proteomic discovery platforms have led to significant discoveries in several disease areas, including prostate, bladder, colon, and breast cancers. Metamark is a leading provider of specialty urological pathology testing services with the first fully integrated clinical model for the prostate cancer care pathway.

For more information on Metamark, please visit the company’s website: www.metamarkgenetics.com.

About Hologic^®
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company’s core business units focus on diagnostics, breast health, GYN surgical, and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure^®.

For more information on Hologic, please visit the company’s website: www.hologic.com.

Metamark^® is a registered trademark of Metamark Genetics, Inc.

Hologic^®, Panther^®, Progensa^® and The Science of Sure^® are registered trademarks of Hologic, Inc.