- Development of novel cancer tests also part of the collaboration -
NEW YORK and QUEBEC CITY, June 29, 2011 /PRNewswire/ -- Signal Genetics, a privately held predictive genetic testing company focusing on oncology, and DiagnoCure, Inc. (TSX: CUR), a life sciences company that develops and commercializes high-value cancer diagnostic tests, today announced a collaboration arrangement valued at US$13.3M over the first five years. This collaboration aims to maximize the commercialization of Previstage™ GCC Colorectal Cancer Staging Test, and further develop novel genomic cancer tests in the field of Personalized Medicine.
Under the definitive agreements underlying the collaboration, Signal Genetics is granted a worldwide exclusive license to the Previstage™ GCC Colorectal Cancer Staging Test developed by DiagnoCure, and acquires DiagnoCure's U.S. CLIA service laboratory. These two elements of the transaction combined are valued at a minimum of US$10.8M over five years, broken down into a US$5.7M upfront payment for the acquisition of DiagnoCure's U.S. laboratory, and a minimum of US$5.1M in annual installments and royalty payments over the first five years of the license agreement. In addition, Signal will pay DiagnoCure US$2.5M under an R&D agreement to advance the development of certain genomic tests being developed in its Quebec-based laboratories. All payments will be made in cash.
"Previstage™ GCC has been shown to offer key clinical information to improve colon cancer management and has an estimated global market potential of over US$400M," stated Joe Hernandez, CEO of Signal Genetics. "We are excited to add it to our product portfolio. With our new subsidiary, CC Health LLC, we plan to expand our sales force and our marketing partnerships to sell the test nationwide. Moreover, the R&D agreement provides Signal and its affiliates access to DiagnoCure's extensive experience in developing personalized genomic tests in oncology that are complementary technologies to the company's pipeline."
"After reviewing many options and opportunities for our U.S. division over the past months, this collaboration arrangement with Signal Genetics emerged as the best strategic path to maximize the commercialization of Previstage™ GCC, and leverage DiagnoCure's assets and R&D expertise," noted Dr. Yves Fradet, President and Chief Medical Officer of DiagnoCure, Inc. "Moving forward, the new inflow of funds, added to the growing revenues generated by the sale of the PCA3 prostate cancer test, will strengthen DiagnoCure's financial base, and allow us to build on our core expertise in developing clinically relevant and robust genomic tests in cancer, in particular lung cancer."
The definitive agreements were executed on June 28, 2011.
Conference call and webcast at 8:30 am
Signal Genetics and DiagnoCure will hold a conference call this morning at 8:30 a.m. EDT to provide further details on the transaction. The call will be webcast live through DiagnoCure's website at www.diagnocure.com - Investors page – Presentations. To take part in the Q&A session, dial 1-877-974-0445 (514-807-8791 for Montreal participants), subject "DiagnoCure special announcement", Conference ID: 4452369.
About Colorectal Cancer and Previstage™ GCC
Every year in the United States and Canada, 165,000 people are diagnosed with colorectal cancer. Of that number, 69,000 are considered at low risk after their surgery. Yet, up to 20% of them suffer recurrence of a more advanced cancer.
Previstage™ GCC is currently the only colorectal cancer staging test on the market that provides prognostic information based on the tumor burden measured at the molecular level in the lymph nodes. Tumor burden in the lymph nodes has become more widely recognized by treating physicians as a key prognostic factor to determine the risk of recurrence of cancer patients, and hence, to determine which patients might benefit most from adjuvant chemotherapy and which could be safely managed without chemotherapy.
To date, results of published studies totaling over 1,000 patients have shown that the GCC biomarker is a better predictor, than traditionally-used factors, of disease recurrence in early-stage colorectal cancer patients.
In particular, in a recent study (Annals of Surgical Oncology, May 2011), in a sub-set of 181 stage II colon cancer patients, the Previstage™ GCC test classified one-third of patients as having a high risk of recurrence following surgery and two-thirds of patients at low risk of recurrence. The high risk group had a six times greater likelihood of recurrence than the low risk group (27% versus 4%).
About Signal Genetics
Signal Genetics, the parent company of Myeloma Health LLC, Respira Health LLC and CC Health LLC, is a privately held predictive genetic testing company focused on improving the treatment of cancer patients. The goal of Signal Genetics is to provide cancer patients and their physicians with novel and innovative insights into their disease, including predictive outcome of disease stage, odds of relapse, and the optimal treatment regimen based on their specific genetic expression profile. The Company launched its first molecular diagnostic test in December, 2010, Myeloma Prognostic Risk Signature (MyPRS™) via its CLIA laboratory in Little Rock, Arkansas. Signal Genetics has marketing partnerships with two large, national laboratories, including Caris Life Sciences and NeoGenomics Laboratories. Additional information is available at www.signalgenetics.com.
About DiagnoCure
DiagnoCure (TSX: CUR) is a life sciences company that develops and commercializes high-value cancer diagnostic tests that increase clinician and patient confidence in making critical treatment decisions. In 2008, the Company launched the Previstage™ GCC Colorectal Cancer Staging Test through its U.S. CLIA laboratory. The Company also has a strategic alliance with Gen-Probe (NASDAQ: GPRO) for the development and commercialization of a second-generation prostate cancer test using PCA3, DiagnoCure's proprietary molecular marker. This test is available through laboratories in the U.S. and in Canada using PCA3 analyte specific reagents (ASR) from Gen-Probe, and in Europe as the CE-marked PROGENSA® PCA3 in vitro assay. For more information, visit www.diagnocure.com.
Forward-looking statements
This release contains forward-looking statements that involve known and unknown risks, uncertainties and assumptions that may cause actual results to differ materially from those expected. By their very nature, forward-looking statements are based on expectations and hypotheses and also involve risks and uncertainties, known and unknown, many of which are beyond DiagnoCure's control. As a result, investors are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements regarding the outcome of research and development projects, clinical studies and future revenues are based on management expectations. In addition, the reader is referred to the applicable general risks and uncertainties described in DiagnoCure's most recent Annual Information Form under the heading "Risk Factors". DiagnoCure undertakes no obligation to publicly update or revise any forward-looking statements contained herein unless required by the applicable securities laws and regulations.
SOURCE Signal Genetics