- With so much Covid-19 infection asymptomatic, many see surveillance testing as key to keeping employees safe.
- One biotech CEO put together a system for 50 companies that returns results in a median of 12 hours.
- The testing enabled researchers to get back to labs safely since clinical research can't be done from home.
When the Covid-19 pandemic struck the U.S., young biotech company Verve Therapeutics was just months away from a pivotal development: studies in animals of its gene-editing approach to lowering cholesterol that would lead it to be heralded as a potential "cure for heart disease."
But Chief Executive Dr. Sekar Kathiresan had a problem: this isn't the kind of work you can do at home.
"Our work involves work in cells and animal models," Kathiresan said.
Initially, his company employed tools like social distancing, hand hygiene, masks and a symptom questionnaire to try to keep employees safe in the labs.
"But it became very clear early in the pandemic that about 40% of people, when they develop Covid, are asymptomatic," said Kathiresan, who's also a preventive cardiologist and geneticist. "Those individuals, you can't catch with a symptom questionnaire. The only option to identify these asymptomatic individuals before they spread the disease in the workplace is to do regular surveillance testing."
It wasn't clear how to do that kind of testing. Back in March, even people sick with what they thought was Covid-19 couldn't get a test.
Kathiresan felt he needed to ensure his company could catch any potential infections that might go undetected, in order to keep his employees healthy. So he tapped his connections. Verve's offices are in the middle of Kendall Square, in Cambridge, Massachusetts, the heart of the world's biotechnology industry. Kathiresan and a couple of biotech CEOs in the area got together to see if they could establish a testing infrastructure to keep their employees safe as they continued to work in labs developing potential medicines.
They started with the Broad Institute, a nonprofit just around the corner in Cambridge that happens to be one of the world's largest genome research centers. Before co-founding Verve, Kathiresan directed the cardiovascular disease initiative at Broad. He knew that the institute was working to get Food and Drug Administration authorization of a Covid test, so he reached out to Stacey Gabriel, senior director of the genomics platform.
"When the pandemic started, and testing was really ramping so slowly, in local hospitals and around the area, one of the faculty members of the Broad Institute, an infectious disease doctor from Brigham and Women's, Deborah Hung, came to me and said, 'You've got a CLIA lab. You've got an incredible amount of automation and expertise in high throughput processes. Could you stand up this test?'" Gabriel recalled. "And that was really the beginning of all of this. That was the second week of March."
The Clinical Laboratory Improvement Amendments require a laboratory be certified by the Centers for Medicare and Medicaid Services before it can accept samples for diagnostic testing.
The Broad team developed its own test and took about two weeks to transform a lab from one focused on genome sequencing to one that did Covid diagnostics. Initially, the lab could do 1,000 tests a day, then ramped up to 10,000, and now has instrumentation in place to do about 35,000 tests a day.
Its early users were hospitals like Brigham and Women's and Mass General. It then started a pilot in early April to test the city of Cambridge's nursing homes.
"It was a couple thousand tests," Gabriel said. "We detected around 200 infected individuals between the residents and staff that the nursing homes and Cambridge were then able to act on."
The Broad has since added 145 staff members to help with Covid testing, and it's expanding into Massachusetts' community health centers, as well as providing testing for colleges and universities, like Harvard.
Kathiresan calls Gabriel "one of the unsung heroes of this pandemic" in the local community.
To facilitate the testing process, he turned to Color, a Bay Area health technology company that had been ramping up testing on the West Coast, and which now says it provides about two-thirds of the testing for the city of San Francisco. Like the Broad, Color had seen the testing logjams at the beginning of the pandemic from the other coast.
"We saw that there was a huge crisis happening," said Caroline Savello, Color's chief commercial officer. "Testing locked up in traditional health-care systems."
Color began doing both its own testing, and providing infrastructure that Savello said can be layered on top of other labs, like the Broad's. It streamlines the testing process with all-digital appointment making and results notification, and operates testing sites.
In Cambridge, those sites are two trailers provided by Alexandria Real Estate, the largest landlord to biotech companies, that sit in a parking lot in Kendall Square's biotech hub. More than 50 biotech companies are now part of the testing group. The median turnaround time for results is 12 hours. The tests each cost $80.
Verve's employees have been getting tested once a week, and now have moved to twice a week as the Boston area will soon see a swell of college students returning, and as there's been a slight uptick in infection in Massachusetts, Kathiresan said.
Massachusetts' seven-day average in new daily cases rose by 90% in early August, to 423, from its lows in early July, according to data from the Covid Tracking Project, a data source run by journalists at the Atlantic.
"This has been an expense, I think, that's been well worth it," Kathiresan said. "I can't think of a better use of resources than making the work environment as safe as possible."
And, he noted, "we've been able to hit all of our research and development milestones."
— CNBC's Harriet Taylor contributed to this report.