Ovation, a Cambridge, MA-based startup company, told Outsourcing-Pharma that a project centered around its cloud-based laboratory information management system (LIMS) could benefit the industry by enabling independent laboratories to broaden their capabilities, effectively doubling nationwide testing capacity.
Barry Wark, Ovation’s co-founder and CEO, told us his company’s Ovation Diagnostic technology has the potential to assist laboratories across the country with gathering and managing the necessary information to develop timely solutions.
“In the clinical world, adding a new test to a clinical lab’s repertoire generally takes a long period of design, development, optimization, standardization, validation and authorization to begin testing patient samples," he explained. "The government has allowed emergency use authorization (EUA) to be utilized to get ahead of this pandemic, allowing rapid adoption of an authorized test with leaner validation requirements.”
Still, Wark pointed out, the laboratory’s informational infrastructure must be able to handle the data management associated with tests and reporting. He explained the Ovation platform, which offers standardized reporting features, allows properly equipped laboratories to quickly ramp up testing of patient samples once validation studies are wrapped.
“Being cloud-based, the workflows and reporting are easily deployable to new labs, increasing testing capacity across the US rapidly," he said, adding the technology has the capability to nimbly respond to ever-changing regulatory requirements, enabling labs to keep current and compliant.
The company announced that Fishers, IN-based Quantigen Biosciences and Charleston, SC-based Vikor Scientific plan to use the platform on their respective COVID-19 testing efforts shortly.
“With Ovation’s support we were able to bring this new assay online at unprecedented speed. We are ready to provide COVID-19 testing at scale to meet the community demand for detection of this deadly and dangerous pathogen,” said Shea Harrelson, Vikor Scientific co-founder.
Jami Elliot, CEO and founder of Quantigen Biosciences, said Ovation’s development team, and familiarity with guidelines from the US Food and Drug Administration (FDA) and Centers for Disease Control (CDC), made the company a favorable partner in developing its COVID-19 testing solutions.
“We are urging our colleagues at other independent laboratories across the country to join this effort today because there is no time for waiting,” she said.
The company reports the Ovation LIMS features of particular use in this application include online order entry, standardized infectious disease workflow, automated interpretation following FDA and CDC guidelines, branded report template, and multimodal report delivery.
Additionally, the company offers resources to help laboratory personnel with assay validation and FDA Emergency Use Authorization submission.