Launching Cologuard, Exact Sciences’ FDA Approved Colon Cancer Screening Test

An Exact Sciences / Sampleminded Collaboration

Exact Sciences Corp. (NASDAQ:EXAS) is a molecular diagnostics company focused on the early detection and prevention of colorectal cancer. The company’s goal was to create the first FDA-approved noninvasive stool DNA screening test for colorectal cancer, Cologuard®.

Exact Sciences knew a key to their success would be to manage their samples accurately and efficiently with the right laboratory system. But the team was also aware that a traditional LIS or LIMS system could be resisted by their technicians and viewed as a frustrating extra step that interrupted their work. Their solution: partner with Sampleminded to deploy laboratory tools that would integrate seamlessly with their process.

Sampleminded knew that a critical first step in building the right system was to understand the Exact Sciences workflow, so they kicked off their partnership by getting hands-on experience in the lab. They put on their gloves and safety glasses and walked through a simulation of the entire stool processing workflow using bananas as their “samples”. Along the way, the team used their expertise to anticipate potential problems and discuss with the Exact Sciences team how to these issues could be handled. After gaining a detailed picture of the lab’s process, Sampleminded was able to build a solution that aligned seamlessly with the Cologuard test workflow.

Both teams were also determined to overcome any negative preconceptions of working with a traditional LIS by building a system that was an integral part of the process, knowing that if the lab workers didn’t need it, they wouldn’t like to use it. Sampleminded’s emphasis was on designing something that would be useful to the lab every day, assisting when something went wrong but not interrupting when things were going right.

By working closely with Sampleminded and developing the right solution from the start, Exact Sciences’ very first Cologuard sample was received directly in the Sampleminded system, eliminating the need to backfill or migrate data later. This strategy really paid off when, nine months later, Exact Sciences had to do a validation of their testing innovation:

“We knew we had found a great partner in Sampleminded, but we saw the true value of their software during our CAP audit,” said Theran Myers, Technical Laboratory Manager, Exact Sciences. “The team was on call to provide us support throughout the audit but we never needed them. We called them when it was over to thank them — and to pass along the auditors’ compliments on their system!”