RESEARCH TRIANGLE PARK — Advanced Animal Diagnostics, as the name suggests, makes tests for animals, not humans.
However, in the age of coronavirus, this small ag tech company from Morrisville finds itself “repurposing” its QScout blood test platform — designed to detect disease in cattle — to now be used for screening COVID-19 in humans.
“We always knew there were applications for technology in the human market,” said AAD’s CEO and President Joy Parr Drach. “We had planned to eventually develop products; we just hadn’t expected to do that so soon.”
This month, it got a boost from the North Carolina Biotechnology Center when it picked the startup for the Wells Fargo Innovation Incubator, or IN2.
Launched in 2017 with $5 million from the Wells Fargo Foundation, the Channel Partner Awards is a competitive program open to IN2 channel partners — a network of more than 60 cleantech and sustainability-focused incubators, accelerators, and universities that refer promising startups to the program
As a channel partner, NCBiotech tapped AAD for this year’s incubator, which accelerated its 2020 awards to provide $900,0000 in immediate relief to cleantech and sustainable agriculture startups managing through the economic disruption caused by COVID-19.
AAD received $50,000, along with 17 other startups around the country.
“This is certainly an opportunity that nobody would have expected to come out of the animal health diagnostic space,” said Paul Ulanch, Ph.D., executive director for the Crop Commercialization Program at NCBiotech.
“This is a chance to really help others. It’s also an opportunity to move an ag tech company along. Now they’re able to get the ball rolling.”
“If COVID-19 has done anything, it’s taught us we live in a ‘One Health’ world,” added AAD’s founder and chief scientific officer Rudy Rodriguez, who started the company in 2001. “We know our livestock technology can make a difference by precisely targeting antibiotic use, and we hope to make a difference with the world’s fastest, most rugged white blood cell differential.”
Parr Drach said the funds will allow the company to continue its efforts to file a 510(k) application for its human test with the U.S. Food and Drug Administration.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is safe and effective.
For years now, farmers have used AAD’s QScout MLD test on dairies to detect subclinical mastitis or its QScout BLD blood test animal-side in feedlots to get a snapshot of a calf’s immune system. The test runs on AAD’s portable “lab-in-a-box” diagnostic platform, the QScout Lab, which provides test results in 32 seconds to guide antibiotic use.
This March, the race to pivot to a human test started when Parr Drach and Jasper Pollard, AAD’s head of R&D, were meeting with a clinical care head at a hospital who tipped them off to the usefulness of a white blood cell differential in COVID-19.
In that moment, Parr Drach realized that AAD’s QScout test had the potential to be used on humans in the fight against COVID-19.
“Our test can save lives and extend our limited medical resources. If we can make that kind of contribution, how could we not pivot?” she said.
For the last few months, Parr Drach and her small team have been collecting verification data to submit as part of its 510(k) application. That includes conducting a study using donated human blood.
NCBiotech, as it turns out, also helped in this regard.
“Our connection to the Biotech Center has been so helpful in so many ways,” she said. “Staff members have even bled for us.”
She wasn’t kidding.
Back in May, AAD set up an outdoor testing lab in its parking lot. It was one of series of collections where the team conducted the two-minute test outside, alongside the patients using QScout technology. It was then sent to a central lab for comparison testing.
Many NCBiotech staff members turned up to give blood, including Michelle VonCannon, NCBiotech’s agriculture program and event manager.
“They had their little tents and QScout machine. They drove up and had the phlebotomist there,” she said.
She didn’t hesitate, even with her young son in tow: “It’s vital to get faster diagnostics in order to get a better hold on containment. If donating blood is the least I can do, I’m on board.”
NCBiotech helped fund its research and development from its time as a young startup, with a $20,000 loan back in 2006.
The support helped the company attract equity capital from North Carolina investors, including Burlington-based LabCorp and Intersouth Partners of Durham, and from investors outside North Carolina including Novartis Venture Funds, Cultivian Sandbox, Middleland Capital and the Kansas Bioscience Authority.
Parr Drach said she’s grateful to NCBiotech for its support over the years, and to the volunteers who gave samples. She’s also looking ahead.
“We were very pleased with the performance of our test run outdoors — in a minute and a half, patient-side, when compared to the central lab test. That data has been used as part of our verification testing for an FDA submission. Our focus right now is how quickly can we get it into the hands of those who need it.”
(c) North Carolina Biotechnology Center