Healthcare Industry News:  Prostate Cancer 

Diagnostics Oncology

 News Release - March 10, 2016

ProMark(R) Prostate Cancer Prognostic Now Included in NCCN Guidelines

Metamark continues to advocate for broader adoption of precision medicine in Prostate Cancer care

CAMBRIDGE, Mass., March 10, 2016 -- (Healthcare Sales & Marketing Network) -- Metamark Genetics, Inc., ("Metamark" or the "Company"), a leader in commercializing high-value urologic oncology products, today announced that ProMark®, the first and only protein-based prognostic test for early-stage Prostate Cancer, has been included in the 2016 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines1.

"The inclusion of tissue-based prognostic tests in the NCCN Guidelines reflects the significantly changing landscape of Prostate Cancer patient management," said Dr. Jerome Richie, chief medical officer. "Per the Guidelines, molecular assays performed on biopsy or prostatectomy specimens can provide prognostic information independent of NCCN risk groups. This update demonstrates the growing clinical adoption of critical molecular tools, such as ProMark, in the care of patients with clinically localized Prostate Cancer."

ProMark predicts cancer aggressiveness in patients with biopsy Gleason Scores of 3+3 and 3+4, providing a fully independent and personalized prediction that the cancer can be managed without aggressive treatment, or an indication that therapy may be appropriate.

"ProMark's recent inclusion in the NCCN Guidelines is an important and exciting milestone that supports Metamark's position as a leader in prognostic testing. In addition, as the exclusive worldwide sales agent for the Progensa® PCA3 IVD Test Kit, an FDA-approved urine-based molecular diagnostic also included in the NCCN Prostate Cancer Early Detection Guidelines2, Metamark is gaining strong momentum in our mission to deliver critical, decision-making information across the management and treatment of Prostate Cancer," said Jerry Williamson, president and chief executive officer. "ProMark and Progensa PCA3 join our comprehensive and growing menu of urology-specific innovative testing, providing better information to physicians and their patients throughout the complete diagnostic and therapeutic care journey."

About ProMark®

Launched in late 2014, ProMark® is the first proteomic classifier of biopsied prostate tissue to assess whether an early-stage prostate tumor is aggressive or indolent. Test results generated in Metamark's Cambridge, Mass. CLIA-certified laboratory can aid the decision whether to treat the cancer aggressively or to choose a course of active surveillance.

About Progensa® PCA3

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. Through the acquisition of HealthTronics Laboratory Solutions in 2013, Metamark has become 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, please visit the company's website:

Metamark® and ProMark® are registered trademarks of Metamark Genetics, Inc.

Progensa® is a registered trademark of Hologic, Inc.

1 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Prostate Cancer (Version 2.2016). Accessed March 2016.

2 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Prostate Cancer Early Detection (Version 1.2016). Accessed March 2016.

Source: Metamark Genetics

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