GenMark Diagnostics (NASDAQ:GNMK), a California based molecular diagnostics company, is expected to price its IPO this week.
Business Overview (from prospectus)
We are a molecular diagnostics company, or a company which detects and measures DNA and RNA targets to diagnose disease and to optimize the treatment of patients, focused on developing and commercializing our eSensor detection technology. Our proprietary electrochemical technology enables fast, accurate and highly sensitive detection of up to 72 distinct segments of target DNA, which we refer to as biomarkers, in a single sample. We received 510(k) clearance for our XT-8 System from the Food and Drug Administration, or FDA. Our XT-8 System is designed to support a broad range of molecular diagnostic tests with a compact and easy-to-use workstation and self-contained, disposable test cartridges. Within 30 minutes of receipt of an amplified DNA sample, our XT-8 System produces clear and accurate results. Our XT-8 System supports up to 24 test cartridges which can be run independently, resulting in a highly convenient and flexible workflow for our target customers, which are hospitals and reference laboratories.
We have developed four diagnostic tests for use with our XT-8 System and expect to expand this test menu by introducing two to four new tests annually. Our Cystic Fibrosis Genotyping Test, Warfarin Sensitivity Test and Thrombophilia Risk Test have received FDA clearance. Our Respiratory Viral Panel Test is currently labeled for investigational use only, or IUO, and we intend to obtain FDA clearance for this test. We also have a pipeline of eight potential products in development or design, including a Plavix Sensitivity Test and a K-ras Mutation Test.
Offering: 4.5 million shares at $8 - $10 per share. Net proceeds of approximately $15 million will be used for the development of a broad menu of tests, $10 million to fund planned sales and marketing initiatives and $3 million to continue to develop AD-8 System.
Lead Underwriters: Piper Jaffray (NYSE:PJC)
Revenue increased $211,000 to $399,000 for the three months ended March 31, 2010 compared to $188,000 for the three months ended March 31, 2009...Cost of sales decreased $807,000 to $567,000 for the three months ended March 31, 2010 compared to $1.4 million for the three months ended March 31, 2009...Research and development expense increased $23,000 to $1.5 million for the three months ended March 31, 2010 compared to $1.4 million for the three months ended March 31, 2009...Net loss increased to $4.8 million for the three months ended March 31, 2010 as compared to $4.4 million for the three months ended March 31, 2009...
We primarily face competition in the molecular diagnostic testing markets with testing products and systems developed by public and private companies such as Cepheid (NASDAQ:CPHD), Gen-Probe, Inc. (NASDAQ:GPRO), Hologic, Inc. (NASDAQ:HOLX), Luminex Corporation (NASDAQ:LMNX), Nanosphere, Inc. (NASDAQ:NSPH), Qiagen NV (NASDAQ:QGEN) and Roche Diagnostics (OTCQX:RHHBY). Our diagnostic tests also face competition with the LDTs developed by national and regional reference laboratories and hospitals. We believe that the XT-8 System competes largely on the basis of accuracy and reliability, enhanced laboratory workflow, multiplex capability, ease-of-use and return on investment for customers.