GRAIL’s mission is to save lives and improve health by pioneering new technologies in early cancer detection. GRAIL’s new multi-cancer early-detection test, Galleri, harnesses the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer and data science.

An early version of Galleri demonstrated its ability to detect more than 50 types of cancer with a false positive rate of less than 1%. These exciting results gave GRAIL great confidence in the product’s viability. They were eager to get it in market. In March 2020, just as the COVID-19 pandemic started in earnest in the U.S., GRAIL leadership began looking for a strategic partner that could build a new genetic testing lab to allow them to quickly ramp up production and distribution. With Galleri’s commercial release looming, GRAIL needed to achieve operational readiness on an accelerated timeline.

Especially considering the challenges presented by the pandemic (supply chain bottlenecks, travel restrictions, increased costs, personnel issues, safety concerns, etc.), GRAIL’s goal to complete the design and construction of their new facility within 12 months was aggressive. Even without the added stressors of the pandemic, this timeline would have been considered risky. It was therefore paramount to find a partner that could accommodate this quick turnaround while maintaining quality and compliance. Enter 35 North.

• Site selection. The 35 North team was involved from the beginning, providing input on site selection to help GRAIL’s leadership team choose a location that would best accommodate their accelerated timeline as well as the nuances of processing the Galleri test. 35 North’s deep roots in North Carolina allowed them to provide detailed guidance founded in their firsthand experience constructing some of the state’s most advanced biotech facilities. With this in mind, GRAIL elected to renovate an existing warehouse in Research Triangle Park.
• Program management. As the owner’s representative, 35 North also delivered program management services, ensuring the original project scope was preserved and incorporated into the design documents. This role also allowed 35 North to identify critical decision points, provide quality control, and keep an eye on the cost and schedule of the project.
• Project management. Due to travel restrictions, most of the design work had to be completed remotely, with the team meeting via video conference. The design team was in Texas, the engineers in North Carolina and Texas, and GRAIL leadership in California. As the project manager, 35 North worked to set up sustainable communication channels that allowed these teams to collaborate seamlessly and kept the project moving forward.
• Troubleshooting. To keep the project on schedule and find a solution for long-lead equipment, the team located air handlers on the shelves of manufacturers and designed the HVAC system around the availability of this equipment. While this led to some challenges with communication between the equipment and the building maintenance system, 35 North’s commissioning team worked through these challenges to ensure all issues were resolved before leaving the site.
• Cost-estimating services.The 35 North team also verified the general contractor’s cost estimate and provided value engineering opportunities to reduce the final project cost.

Throughout the 12-month duration of this project, the 35 North team worked diligently to overcome several pandemic-related challenges: the truncated schedule, material delays, a geographically dispersed team, and increasing costs, just to name a few. In the end, the project was completed on schedule and on budget, allowing GRAIL to achieve their goal of operational readiness in a year.

Apart from adherence to the strict schedule, 35 North also ensured the facility was designed and built according to GRAIL’s unique specifications for the Galleri test. When completed, this 120,000-square-foot facility included high-end 2-8°C and -20°C walk-in storage, an ambient control warehouse, data center, clean rooms, laboratories, and support offices.