CHICAGO – Scientific data management and clinical informatics firm Ovation.io wants its cloud-based laboratory information management system to serve as a hub for many of the estimated 2,500 molecular diagnostics labs in the US that do not currently offer testing for the novel SARS-CoV-2 coronavirus.
The company said that its initiative has the potential to double SARS-CoV-2 coronavirus testing capacity in the US, where testing has lagged the rest of the post-industrial world.
Cambridge, Massachusetts-based Ovation.io announced its ambitious effort last Friday with two laboratory customers offering testing for the virus that causes the COVID-19 respiratory disease. As of Wednesday afternoon, the company had 22 labs participating.
Ovation.io has invited the more than 100 LIMS customers in its network to participate. The startup said that all of the independent laboratories in the US could start testing in short order if they joined.
Ovation estimated there are 2,500 high-complexity, CLIA-certified labs that already run PCR tests and thus are in good position to add SARS-CoV-2 assays. All they would have to do is bring in tests from Thermo Fisher Scientific or the US Centers for Disease Control and Prevention that received Emergency Use Authorization from the US Food and Drug Administration, or use their own laboratory-developed test and validate it, according to Pauline Gee, Ovation's head of clinical affairs.
Gee said that the company has so far only updated its platform to handle these tests, not those from commercial suppliers other than Thermo Fisher.
According to Ovation Cofounder and CEO Barry Wark, many of the high-complexity CLIA labs in the country "are sitting on the sidelines for COVID-19 testing, and you can imagine that there are a number of hurdles there."
Among these are CDC regulatory hurdles, including the application for an Emergency Use Authorization, which Ovation can assist its clients through. The company also can help them navigate the supply chain, though the company does not offer testing supplies itself.
Above all, Ovation is selling itself as a workflow management partner to analyze data and generate reports.
Ovation has been in business since 2009, but its first labs did not come online until 2017. In these last three years, the company has mostly served independent MDx labs.
COVID-19, said Wark, "is a chance for all of these independent labs to come together with a pretty singular purpose, which is solving this huge testing gap in the US."
"Testing is the key to understanding epidemic outbreaks and [helping with] control, knowing what the actual situation is on the ground. Every disaster manager will tell you that what they want is information, and these labs are critical healthcare infrastructure," Wark said. "We're just trying to make sure that many of them can be online and contributing to this effort as possible, as quickly as possible."
The firm's laboratory information management system, Ovation Diagnostic (OvDx), is a cloud-based MDx platform that helps labs track samples, manage their revenue cycles, and conduct business and results analytics.
In the context of SARS-CoV-2, the company provides online order entry, automated results interpretation following CDC and FDA guidelines, report delivery, and support through assay validation and FDA EUA submission.
The cloud and software-as-a-service nature of the Ovation platform makes the technology nimble, according to Wark.
"And as a cloud-based [software-as-a-service], we're in a very high-leverage situation to be able to help them understand the regulatory guidance and to move through that hurdle and to have the informatics ready to go rather than having to rebuild these rules 2,500 times," Wark said. "We can track the latest guidelines and help these labs with data analysis right out of the gate."
He said that the technology is highly configurable, without the need for a lot of custom programming.
"Everyone on the Ovation platform can instantly take advantage of the COVID testing workflow and data analysis tool that we released," last week, Wark said.
That is exactly what one of the company's first labs offering SARS-CoV-2 testing, Vikor Scientific, an independent molecular diagnostics company in Charleston, South Carolina, was looking for. Vikor, an Ovation customer for about a year, conducts full pathogen panels for patients with infectious diseases, and received its EUA for the Thermo Fisher SARS-CoV-2 kits on Monday.
"In launching a new test, you run into all kinds of barriers, especially right now with COVID-19 as far as obstacles from disposable supplies to arrays and the reagents," said Vikor Scientific Cofounder Shea Harrelson.
Typical LIMS take three to six months to set up reports for new MDx tests, but Ovation provided a new report for COVID-19 essentially overnight. "It was the one thing that we did not have to be concerned with, which is usually the opposite," Harrelson said.
Vikor Scientific moved into a new, 22,000-square-foot headquarters facility just a few months ago and performs open-array testing on Thermo Fisher's QuantStudio 12K Flex equipment. Harrelson expects the lab to turn around COVID-19 results within 24 hours of the time a sample arrives.
"We have the machines. We have the people. It was really prime time for us to be able to launch this," she said, adding that the company could run anywhere from 500 to 1,500 SARS-CoV-2 tests per day.
While the process for getting EUA is similar to any testing approval, Wark said that the urgency of the COVID-19 pandemic right now has put a lot of pressure on MDx labs.
Further complicating the problem is the changing nature of the rules as regulators, including the CDC, try to get a handle on a novel virus and disease.
Wark said that labs are struggling to make sense of the rules and processes, and Ovation can help them do so.
Gee added that "the FDA and the CDC have been really proactive in smoothing the way through the compliance pathway to get these labs up and running. The fact that they've actually given [SARS-CoV-2 tests] Emergency Use Authorization has been a big plus and they've actually been very definite in the guidelines in what needs to be done to get the test out," Gee said.
She said that Ovation has an advantage in that its network includes high-complexity labs all over the country.
Gee, who joined Ovation in September after working as an independent consultant in clinical laboratory compliance, has been helping the company's clients implement all kinds of precision medicine, not just COVID-19 testing.
"We've taken the requirements that are set by the FDA Emergency Use Authorization, both for the Thermo Fisher kit and what the [FDA] has set in their guidelines," she said. "Ovation can actually automate this really quickly and standardize it for all labs."
The CDC guidelines also cover laboratory-developed tests. "Ovation can take that and code it in so that it's automated," Gee said.
According to Wark, a cloud-based platform like Ovation's provides the flexibility to get labs online as quickly as possible during this time of crisis. The vendor tracks the experience of all its customers and is able to push updates out to its entire network quickly.
Those on the front lines, such as lab and hospital personnel at drive-through testing sites, can enter orders through Ovation's web portal that runs on mobile devices.
Ovation also facilitates reporting to the CDC and state and local public-health authorities.
Ovation has a team of about 50 people, distributed across its Boston-area headquarters, as well as offices in Indianapolis, Seattle, and Portland, Maine.
Wark would not specify the cost of joining the network but said that Ovation's services would be affordable. "For labs that are doing COVID-19 testing, we're making additional capability available at a significant discount," he said.
The software company is not publicly promising how fast it can help a lab start SARS-CoV-2 testing due to the need to run validation assays and obtain testing certification from the CDC and FDA.
Gee said that it takes about a week for a lab already running PCR testing to complete the validation assay. Ovation could deploy its platform once the lab is certified to run the coronavirus test.
"We're just happy that we can help make an impact here in this moment of need," Wark said.