A Buffalo startup played a key role in helping researchers obtain quick approval for a Covid-19 test that relies on a person's saliva, rather than using swabs.
Circuit Clinical was able to quickly recruit 99 local residents to provide saliva samples to help researchers determine if a saliva test would yield the same results as a blood test. Some of those patients also contributed blood samples, to provide a comparison with what was detected in the saliva samples.
The samples were necessary to validate a device that can measure DNA and RNA in saliva, for submission to the Food and Drug Administration.
Dr. Irfan Khan, Circuit Clinical's founder and CEO, said his company's employees, the volunteer patients and their physicians all played a part in helping the saliva test get FDA authorization on a faster-than-usual timeline.
"You could not get that approval without having that testing done," Khan said. "That's what the people of Western New York and Circuit provided."
Circuit Clinical, a homegrown company that won $500,000 as a runner-up in last year's 43North business plan competition, already had built a business model around connecting patients with clinical trials through their primary care physicians.
Dr. Andrew Brooks, the chief operating officer and director of technology development at Rutgers' RUCDR Infinite Biologics, sought Circuit Clinical's help. His organization collaborated with two other partners on the saliva test.
"As Andy said himself, we got done in 10 days what should have taken seven to 10 months," Kahn said, referring to Circuit Clinical's contribution.
Circuit Clinical recruited 99 unique participants within five different groups of donors. The company already had relationships with health care providers, so it was able to complete its task quickly.
The samples were collected at the end of February, the researchers submitted their application in March, and the FDA granted emergency use authorization in April.
Brooks serves on Circuit Clinical's board of directors, so he knew the company's capabilities.
"The identification of control samples and the recruitment of patients to provide biomaterials is the single most difficult task in the development of any medical device or diagnostic," Brooks said. "The services that Circuit Clinical offers are unique to this application and will quickly become the industry standard."
Brooks, in a statement at the time of the FDA's approval, said a saliva test is a good alternative to nose and throat swabs in different ways. The saliva test doesn't put health care workers at risk of infection while being performed, it preserves personal protection equipment for patient care and it increases the number of people who can be tested each day, he said.
“Saliva testing will also be important for people who are in quarantine because they don’t know how long it will be until they are no longer infectious," Brooks said. "This will allow health care workers to release themselves from quarantine and safely come back to work.”
At last fall's 43North competition, Circuit Clinical delivered a prize-winning pitch about its platform TrialScout, which allows patients to find, choose and rate their clinical trials experiences.
Circuit Clinical has 21 employees and hasn't laid anyone off amid the Covid-19 pandemic, Khan said.
"We have worked so hard for four years to develop a great team, so we just made a commitment that we were going to push through. And that was rewarded with what we hoped would happen, which was that clients and pharmaceutical companies and contract research organizations would come to us and say, 'We have work here, if you have access to patients who would be interested in participating in testing to develop new diagnostics,' " he said.
Khan's vision is for Circuit Clinical to expand its business model statewide, offering clinical research as a care option to a wider population.
Khan said clinical trials tend to have a diversity problem, with too few minorities and women represented. He said Circuit Clinical overcomes that obstacle by working directly with health care providers in those communities.
Khan praised the 99 Buffalo-area volunteer patients who provided samples to validate the Covid-19 saliva test.
"They should be very proud of themselves," he said. "We're very proud of them and very appreciative. And frankly everybody who's getting one of these Covid tests from Dr. Brooks' group is benefiting from that."