How Curative & KorvaLabs Created a Successful COVID-19 Testing Lab in Less than a Month

Say what you will about the current state and availability of COVID-19 diagnostic testing, the energetic, imaginative and speedy response by certain segments of the lab industry has been nothing short of heroic. A case in point is the collaboration between KorvaLabs and Curative to launch a COVID-19 testing firm in Southern California in record time.

Creating the Partnership

The story began in December 2019 when sepsis testing lab Shield Bio ran out of capital and had to close down. Shield CEO Fred Turner responded by founding Curative, Inc. The original plan was to focus on sepsis; but when the pandemic hit, it shifted gears and sought to create a COVID-19 testing lab. What it needed was an existing lab in the region that had the testing equipment, facility and capability to quickly adapt to COVID-19 testing.

KorvaLabs fit the bill. The San Dimas-based high-throughput lab specializing in sports drug testing was willing to partner. KorvaLabs would supply the infrastructure and Curative the infectious disease testing expertise.

Developing the Assay

The next thing the partners needed was a laboratory developed SARS-CoV-2 test. Within 10 days, that assay was created. The team brought the test to KorvaLabs, validated it and began performing it five days later. And on April 17, the Curative-Korva SARS-CoV2 assay received Emergency Use Authorization (EUA) from the FDA.

What distinguishes the Curative-Korva assay from other COVID-19 tests is its capacity to detect SARS-CoV-2 nucleic acids in not only oropharyngeal, nasopharyngeal and nasal swabs, but also oral fluid specimens, an extremely valuable trait given the shortages of nasal swabs. Of equal advantage was that samples can be self-collected with almost any type of sterile swab and without need of any special collection device. Using Zymo Research’s DNA/RNA Shield to stabilize the sample RNA, specimens are transported, stored at room temperature and tested within 24 hours of collection. 

Launching the COVID-19 Testing Lab

Because the lab was set up exclusively for COVID-testing, the team was able to arrange workflows to avoid other bottlenecks, e.g., use of a Norgen Biotek kit allowing for either manual or robotic extraction. Doing just COVID-19 testing also enabled the lab to be flexible in finding reagents, extraction kits and swabs. 

The lab is now doing up to 5,000 tests per day, including first responders, and hasn’t yet reached its testing capacity. Meanwhile, Los Angeles City and County drive-through test sites are also using the Curative-KorvaLab test service.

Takeaway

Four weeks. That’s all it took for Curative and KorvaLabs to partner, develop an assay, secure FDA approval and open a COVID-19 testing lab providing 5,000 tests per day. It’s a remarkable story and, let’s hope, an inspiration and model for many others around the country. 

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This article originally appeared in G2 Intelligence, Laboratory Industry Report, May 2020