Exact Sciences Corporation provides cancer screening and diagnostic test products in the United States and internationally. The company offers Cologuard, a non-invasive stool-based DNA screening test to detect DNA and hemoglobin biomarkers associated with colorectal cancer and pre-cancer. It also provides Oncotype DX, a gene expression tests for breast, prostate, and colon cancers; Oncotype Test, a tissue test delivering tumor profiling to aid therapy selection for patients with advanced, metastatic, refractory, or recurrent cancer; and Covid-19 testing services.
Exact Sciences is best known for Cologuard. Since its approval by the FDA in 2014, Cologuard has been used more than 7.5 million times to screen people for colorectal cancer. In 2018, Exact Sciences acquired San Diego-based blood preservation company Biomatrica – an important component to Exact’s core business of cancer screening tests.
In late February, the company cut the ribbon on a new R&D and product development facility. The company plans to use the additional laboratory space to advance early detection, minimal residual disease (MRD) cancer recurrence monitoring, therapy selection testing and design of the company’s proprietary blood collection tubes.
The new 49,742-SF research laboratory facility is located in San Diego. Exact Sciences currently employs 60 people in San Diego and expects that number to more than double within the next year. Exact Sciences was committed to commissioning this facility to systematically optimize the building and ancillary systems so that they operate efficiently and effectively in accordance with the Owners Project Requirements, and that the facility staff has adequate system documentation, and training. It is the intent of Exact Sciences to ensure that the fundamental systems are calibrated and operating as required to deliver functional and efficient performance.
GMC Commissioning provided full commissioning of all systems on this project starting with creating an OPR to capture the quality expectations of Exacts team. A team of 3 commissioning professionals supported Exact’s internal team in delivering this highly complex facility under an extremely tight deadline. Delays caused a few headaches including a required new natural gas meter which was not installed in time and necessitated a temporary propane system to be implemented to support the schedule. Due to other schedule constraints, we coordinated and executed functional testing after hours to minimize occupant interruptions. Despite these setbacks, GMC Cx was able to successfully turnover an operational, safe, and efficient building to Exact Facilities.