Exact Sciences prepares for November launch of at-home COVID-19 tests

Exact Sciences

After recently receiving its at-home or self-collection authorization from the FDA, Exact Sciences has a new option for employers to test their employees for COVID-19.

The FDA approval allows someone to swab on their own without a medical professional.

Currently, Exact Sciences partners with businesses in the same way it does with the Department of Health Services. It provides the testing supplies, but then it’s up to the business to make sure that a specimen is properly collected and transported back to Exact Sciences’ Madison lab for testing. Then, it’s up to the business to make sure that employees are notified of their test result.

What’s coming next — the at-home test — has a telehealth provider who oversees the order and the result electronically, so there’s no need for a business to have its own on-site or contracted medical professional, said Jake Orville, general manager of Pipeline at Exact Sciences. Orville’s role is to help get new diagnostic tests on the market.  

“This process provides flexible options on how to receive testing supplies either in bulk to you as an employer to hand them out or individually directly to the employee at their home,” he said in a Wisconsin Manufacturers & Commerce virtual event. “This option has dashboards that provide insights to the employer on results and even compliance with who’s performing the testing.”

While several companies are currently using this new process, Exact Sciences and its partner Everlywell expect to have additional capacity in about 60 days. 

“Starting in November, we anticipate this option to be more widely available,” Orville said. “The process is relatively simple. We are starting to contact and contract with select employers starting in October for November availability.”

Exact Sciences is a cancer screening and diagnostic test company based in Madison, well known for its Cologuard test, which aims to detect colon cancer early. Exact decided to use its talent, lab expertise and automated platform to take care of its employees when COVID-19 testing was hard to access at the start of the pandemic. 

“That quickly grew into a broader solution and a broader commitment from Exact in our communities, especially here in Wisconsin,” Orville said. 

Those conversations about employee-focused testing began in early March. By mid-March, Exact started pilot testing. And then on March 30, Gov. Tony Evers announced a public-private partnership between Exact Sciences and others to increase the state’s COVID-19 testing capacity. 

In mid-April, Exact was granted emergency use authorization by the FDA for COVID-19 testing and committed to providing Wisconsin with capacity and supplies for 20,000 tests per week. In mid-July, it processed half a million tests.

“We know the best way to box in this virus is to continue to build our testing capacity, and lab capacity is a one of our big success stories,” said DHS spokeswoman Elizabeth Goodsitt. “We have incredible public/private partnerships in Wisconsin, including a deepening relationship with Exact Sciences, which was among the first to partner with us in boosting testing capacity and enhancing our coordinated response.”

Other notable partners include Promega and Epic, Orville said.

“These private partnerships have enabled DHS and our partners to build and strengthen our capabilities to identify and contain the spread of the disease,” Goodsitt added. “We have excellent clinical and public health labs across the state that are committed to this response – and they need additional support to meet the needs of this response that the clinical labs have been able to help provide.”

With the collection supplies from Exact Sciences, DHS distributes the supplies to health systems, community testing sites or local health departments and nursing homes. After collecting a specimen with a nasal swab, the samples are taken back to the Exact Sciences lab. Results are provided back to the provider or clinician that ordered tests, and that provider or clinician communicates the results to the individual that got swabbed. 

Most of these results are now coming back through email, although all positive tests are called personally, Orville said. 

-By Stephanie Hoff